FrancophonIA/ELRC3.0 huggingface dataset:
English: For storage conditions of the reconstituted or diluted medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet tal-ħżin tal-prodott mediċinali rikostitwit jew dilwit, ara s-sezzjoni 6.3.
English: Not known: frequency cannot be estimated from the available data severe allergic reactions (anaphylaxis).
Maltese: Mhux Magħruf: il-frekwenza ma tistax tiġi stmata mid-data disponibbli reazzjonijiet allerġiċi severi (anafilassi).
English: The studies did not provide any evidence for a genotoxic potential of telavancin.
Maltese: L-istudji ma pprovdew ebda evidenza ta' potenzjal ġenotossiku għal telavancin.
English: VIBATIV is used to treat adult patients with infections of the lungs that have developed in the hospital, including patients on artificial ventilation, when these infections are known or suspected to be caused by bacteria called methicillin-resistant Staphylococcus aureus (MRSA).
Maltese: VIBATIV jintuża sabiex jikkura adulti b'infezzjonijiet fil-pulmun li jkunu żviluppaw fl-isptar, inklużi pazjenti fuq ventilazzjoni artifiċjali, meta l-infezzjonijiet ikunu magħrufa jew issuspettati li ġew ikkawżati mill-batterja msejħa Staphylococcus aureus reżistenti għal methicillin (MRSA).
English: Uncommon: may affect up to 1 in 100 people intestinal bacterial infection; urinary tract infection anaemia, changes in white blood cell counts; changes in blood platelet counts decreased appetite; changes in blood levels of glucose; changes in blood levels of potassium and restlessness; anxiety; confusion; depression loss of taste, migraine, abnormal touch sensation, smell disturbance, sleepiness, trembling chest pain; heart failure; abnormal heart rhythm or heart beat flushing; high or low blood pressure; inflammation of a vein breathlessness, hiccups, nasal congestion, sore throat abdominal pain; dry mouth; indigestion, bloating; numbness of the mouth skin redness; swelling of face; sweating, hives joint pain; back pain; muscle cramp; muscle pain painful urination; blood in urine; low urine output, frequent urination; abnormal urine odour lack of energy; irritation at infusion site; feeling unwell; chest discomfort; accumulation of fluid in the lower legs; pain; fever; skin flushing of upper body
Maltese: Mhux komuni: jista' jaffettwa sa persuna 1 f'100 infezzjoni batterika intestinali; infezzjoni fil-passaġġ tal-urina anemija, bidliet fl-għadd ta' ċelluli bojod tad-demm; bidliet fl-għadd tal-plejtlets fid-demm tnaqqis fl-aptit; bidliet fil-livelli ta' glukows fid-demm; bidliet fil-livelli ta' potassju u manjesju irrikwitezza; ansjetà; konfużjoni; dipressjoni telf tat-togħma, emigranja, sensazzjoni anormali ta' ħass, disturb fix-xamm, ngħas, rogħda;
English: Tell your doctor that you are receiving VIBATIV.
Maltese: Għarraf lit-tabib tiegħek li qed tirċievi VIBATIV.
English: In healthy volunteers who received a dose of 15 mg/kg, a higher incidence of adverse reactions to telavancin was seen: dysgeusia, nausea, vomiting, injection site erythema, headache, macular rash, and red man syndrome.
Maltese: F'voluntieri b'saħħithom li rċevew doża ta' 15 mg/kg, kien hemm inċidenza ogħla ta' reazzjonijiet avversi għal telavancin: tibdil fit-togħma, dardir, remettar, eritema fis-sit tal-injezzjoni, uġigħ ta' ras,
English: For doses of 150 to 800 mg, the appropriate volume of reconstituted concentrate must be further diluted in 100 to 250 ml prior to infusion.
Maltese: Għal dożi ta' minn 150 sa 800 mg, il-volum xieraq tal-konċentrat rikostitwit għandu jiġi dilwit aktar f'100 sa 250 ml qabel l-infużjoni.
English: In the event of overdose, telavancin should be discontinued and supportive care is advised with maintenance of glomerular filtration and careful monitoring of renal function.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Aseptic technique must be used to reconstitute VIBATIV.
Maltese: Uża teknika asettika biex tirrikostitwixxi VIBATIV.
English: The dose for adults (18 years and older) is 10 milligrams (mg) for every kilogram (kg) of body weight, given once a day.
Maltese: Id-doża għal adulti (18-il sena jew aktar) hi 10 milligrammi (mg) għal kull kilogramm (kg) ta' piż tal-ġisem, li jingħata darba kuljum.
English: Caution should be exercised when prescribing telavancin to patients with a prior history of hypersensitivity reaction to vancomycin.
Maltese: Għandha tiġi eżerċitata kawtela meta telavancin jiġi preskritt lil pazjenti bi storja preċedenti ta' sensittività eċċessiva għal vancomycin.
English: VIBATIV 750 mg powder for concentrate for solution for infusion
Maltese: VIBATIV 750 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni
English: Because renal excretion is the primary route of elimination, dosage adjustment is necessary in patients with a creatinine clearance of 30-50 ml/min (see section 4.2).
Maltese: Peress li l-eliminazzjoni mill-kliewi hija l-passaġġ ewlieni ta' eliminazzjoni, l-aġġustament fid-dożaġġ hu meħtieġ f'pazjenti li għandhom tneħħija tal-kreatinina ta' 30-50 ml/min (ara s-sezzjoni 4.2).
English: VIBATIV 250 mg powder for concentrate for solution for infusion VIBATIV 750 mg powder for concentrate for solution for infusion
Maltese: VIBATIV 250 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni VIBATIV 750 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni
English: Bolus injections must not be administered.
Maltese: M'għandhomx jingħataw injezzjonijiet Bolus.
English: The use of VIBATIV is contraindicated during pregnancy (see section 4.3).
Maltese: L-użu ta' VIBATIV fit-tqala huwa kontraindikat (ara s-sezzjoni 4.3).
English: Preparation of the reconstituted concentrate (VIBATIV 750 mg vial) The contents of the vial containing 750 mg telavancin must be reconstituted with 45 ml of either dextrose 50 mg/ml (5%) solution for injection, or water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection to obtain a concentration of approximately 15 mg/ml (total volume of approximately 50 ml).
Maltese: Preparat tal-konċentrat rikostitwit (kunjett ta' VIBATIV 750 mg) Il-kontenut tal-kunjett li jikkonsisti minn 750 mg telavancin għandu jiġi rikostitwit b'45 ml soluzzjoni ta' dextrose 50 mg/ml (5%) għall-injezzjoni, jew ilma għall-injezzjonijiet jew soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride għall-injezzjoni sabiex tikseb konċentrazzjoni ta' madwar 1 mg/ml (volum
English: • Healthcare professionals should be aware that the administration of Vibativ may interfere with some coagulation laboratory tests and qualitative and quantitative urine protein tests.
Maltese: • Il-professjonisti tas-saħħa għandhom ikunu jafu li l-għoti ta' Vibativ jista' jinterferixxi f'xi testijiet tal-laboratorju relatati mal-koagulazzjoni u f'testijiet kwalitattivi u kwantitattivi ta'
English: In the clinical studies, patients with pre existing acute renal failure receiving telavancin had an increased risk of mortality.
Maltese: Fl-istudji kliniċi, il-pazjenti b'falliment akut tal-kliewi li kien jeżisti minn qabel u li kienu qed jirċievu telavancin kellhom riskju ogħla ta' mortalità.
English: Also patients with baseline QTc >500 msec, congenital long QT syndrome, uncompensated heart failure, or abnormal K+ or Mg2+ blood levels that could not be corrected, severely neutropenic (absolute neutrophil count <500/mm3) or anticipated to develop severe neutropenia due to prior or planned chemotherapy, or who had HIV with CD4 count <100/mm3 during the last 6 months were excluded.
Maltese: QT twil, falliment tal-qalb mhux ikkompensat, jew livelli mhux normali ta' K+ jew Mg2+ fid-demm li ma setgħux jiġu kkoreġuti, newtropeniċi severa (għadd assolut ta' newtrofili <500/mm³) jew mistennija li jiżviluppaw newtropenja severa minħabba kimoterapija mogħtija qabel jew ippjanata, u l-pazjenti li kellhom l-HIV b'għadd ta' CD4 <100/mm³ matul l-aħħar 6 xhur ġew esklużi.
English: B. PACKAGE LEAFLET
Maltese: Id-daqsijiet tal-pakkett:
English: VIBATIV powder for concentrate for solution for infusion is provided as a 30 ml or 50 ml clear glass vial with rubber stopper, with an aluminium closure with plastic flip-off caps.
Maltese: VIBATIV jiġi f'kunjett tal-ħġieġ ċar ta' 30 ml jew 50 b'tapp tal-lastku, b'għatu tal-aluminju u għotjien tal-plastik li jinqalgħu bis-saba'.
English: Important information about some of the ingredients of VIBATIV This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'.
Maltese: Tagħrif importanti dwar xi wħud mis-sustanzi ta' VIBATIV Din il-mediċina fiha inqas minn 1 mmol sodju (23 mg) f'kull kunjett, i.e. huwa essenzjalment ‘ħieles mis-sodju'.
English: Gastrointestinal disorders Very common:
Maltese: Disturbi fl-għajnejn Mhux komuni:
English: It is unknown whether telavancin is excreted in human breast milk.
Maltese: Ma ġiex esperjenzat telavancin fuq il-bnedmin.
English: In the rat embryo-fetal development study dilatation of lateral ventricles of the brain was observed in the high dose group.
Maltese: Fl-istudji tal-iżvilupp embrijufetali tal-firien kien osservat twessigħ tal-ventriċi laterali tal-moħħ fil-grupp b'doża għolja.
English: Reporting of side effects
Maltese: INFORMAZZJONI GĦALL-UTENT
English: Information to be collected shall include data on renal impairment, fatal outcomes (assessed for causality), cardiac disorders, liver and hepatobiliary disorders, tinnitus and hearing loss, adherence to the SmPC and off label use.
Maltese: L-informazzjoni li għandha tinġabar għandha tinkludi dejta dwar l-indeboliment tal-kliewi, riżultati fatali (assessjati għall-kawżalità), disturbi fil-qalb, disturbi fil-fwied u epatobiljari, tinnite u nuqqas ta' smigħ, ladeżjoni mal-SmPC u l-użu mhux kif approvat.
English: VIBATIV 250 mg powder for concentrate for solution for infusion
Maltese: VIBATIV 250 mg trab għall konċentrat għal soluzzjoni għall-infużjoni
English: If an allergic reaction to telavancin occurs, discontinue treatment and institute appropriate therapy.
Maltese: Jekk ikun hemm reazzjoni allerġika għal telavancin, waqqaf il-kura u ibda t-terapija xierqa.
English: Elderly
Maltese: Patoġen
English: A retrospective, chart review, post authorisation safety study (PASS) shall be conducted with the objective to further characterise the adverse drug reaction profile of telavancin when used in the clinical setting.
Maltese: Għandha ssir analiżi retrospettiva tal-kartella klinika, studju dwar is-sikurezza wara l-awtorizzazzjoni (PASS - Post Authorisation Safety Study), bl-għan li jiġi kkaratterizzat ulterjorment il-profil tar-reazzjonijiet avversi għal telavancin meta jintuża f'kuntest kliniku.
English: Although telavancin does not interfere with coagulation, it interfered with certain tests used to monitor coagulation (see below), when tests are conducted using samples drawn between 0 to 18 hours after telavancin administration to patients being treated once every 24 hours.
Maltese: Għalkemm telavancin ma jxekkilx il-koagulazzjoni, huwa interferixxa ma' ċertu testijiet li jintużaw biex jimmonitoraw il-koagulazzjoni (ara isfel), meta jsiru testijiet fuq kampjuni li jkunu ttieħdu minn 0 sa 18-il siegħa wara l-għoti ta' telavancin lil pazjenti li jkunu ġew ikkurati darba kull 24 siegħa.
English: Paediatric population
Maltese: TAL-PRODOTT MEDIĊINALI
English: As with other glycopeptides, ototoxicity (deafness and tinnitus) has been reported in patients treated with telavancin (see section 4.8).
Maltese: Bħalma jiġri b'glycopeptides oħra, ġiet irrappurtata ototossiċità (truxija u tinnite) f'pazjenti li kienu kkurati b'telavancin (ara s-sezzjoni 4.8).
English: Patients who develop signs and symptoms of impaired hearing or disorders of the inner ear during treatment with telavancin should be carefully evaluated and monitored (see section 4.8).
Maltese: Il-pazjenti li jiżviluppaw dawn is-sinjali u sintomi ta' smigħ indebolit jew disturbi fil-widna ta' ġewwa waqt il-kura b'telavancin għandhom jiġu evalwati u sorveljati bir-reqqa (ara s-sezzjoni 4.8).
English: Telavancin has a small volume of distribution.
Maltese: Telavancin għandu volum ta' distribuzzjoni żgħir.
English: The liver, kidney, macrophages and testis were identified as target organs of toxicity in animals.
Maltese: Il-fwied, il-kliewi, makrofaġi u t-testikoli kienu identifikati bħala l-organi bersalljati ta' tossiċità fl
English: Caution is warranted when using telavancin to treat patients taking medicinal products known to prolong the QT interval.
Maltese: TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: No evidence of increased bleeding risk has been observed in clinical trials with telavancin.
Maltese: Ma kienx hemm evidenza murija ta' riskji ogħla ta' fsada fil-provi kliniċi b'telavancin.
English: There is no known cross-resistance between telavancin and other non-glycopeptide classes of antibiotics.
Maltese: M'hemmx reżistenza inkroċjata magħrufa bejn telavancin u klassijiet oħra ta' antibijotiċi mhux tat-tip glycopeptides.
English: 3-O-desacyl-4'- monophosphoryl lipid A (MPL)
Maltese: 3-O-desacyl-4'- monophosphoryl lipidu A (MPL)3
English: --1 1 dose (0.5 ml) contains: Human Papillomavirus1 type 16 L1 protein2,3,4
Maltese: --1 Doża 1 (0.5 ml) fiha: Vajrus tal-Papilloma uman1 proteina tip 16 L12,3,4
English: Human Papillomavirus1 type 18 L1 protein2,3,4
Maltese: Vajrus tal-Papilloma uman1 proteina tip 18 L12,3,4
English: 4L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from Trichoplusia ni.
Maltese: 50 mikrogramma adsorbit fuq aluminium hydroxide, idrat (Al(OH)3) 0.5 milligrammi Al b'kollox Proteina L1 fil-forma ta' partikuli bħal tal-vajrus mhux infettivi (VLPs) prodotti minn teknoloġija rikombinanti tad-DNA li tuża sistema ta' espressjoni ta' Baculovirus li tuża ċelluli Hi-5 Rix4446 derivati minn Trichoplusia ni.
English: 1Human Papillomavirus = HPV adjuvanted by AS04 containing:
Maltese: Vajrus tal-Papilloma uman = HPV 2adjuvantat minn AS04 li fih:
English: 1 pre-filled syringe + 2 needles
Maltese: siringa mimlija għal-lest 1 + 2 labar
English: 10 pre-filled syringes
Maltese: 10 kunjetti (b'ħafna dożi)
English: 1 pre-filled syringe + 1 needle
Maltese: 10 kunjetti siringa mimlija għal-lest 1 + labra 1
English: NAO-1 stabiliser
Maltese: Stabilizzant NAO-1
English: To stimulate immunity against Streptococcus equi.
Maltese: Sabiex tistimula l-immunità kontra Streptococcus equi.
English: 10 x 1 dose of vaccine 10 x 1 dose of solvent 10 applicators 10 syringes with needle
Maltese: 10 x 1 doża tal-vaċċin 10 x 1 doża tas-solvent 10 applikaturi 10 siringi bil-labra
English: MARKETING AUTHORISATION NUMBER(S) EU/2/04/043/001
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/04/043/001
English: Lyophilisate:
Maltese: Rivaċċinazzjoni:
English: Figure 3
Maltese: Figura 3.
English: The duration of immunity is up to 3 months.
Maltese: L-immunità ddum sa 3 xhur.
English: Figure 1
Maltese: Figura 1.
English: The vaccine strain is resistant to aminoglycosides, sulphonamides, flumequine and trimetroprim-sulfa combinations.
Maltese: L-istrejn tal-vaċċin huwa reżistenti għal aminoglikosidi, sulfonamidi, flumekwin u kombinazzjonijiet ta' trimetoprim-sulfa.
English: Zero days.
Maltese: Iġbed 0.
English: Allow the sterile solvent to reach room temperature (15-25 °C).
Maltese: Ħalli s-solvent jilħaq it-temperatura tal-kamra (15 - 25oC).
English: Lyophilisate for suspension for injection
Maltese: Lijofilizzat, għal suspensjoni għal injezzjoni
English: 6.5 Nature and composition of immediate packaging Each package of Equilis StrepE contains: 10 vials with lyophilisate and 10 vials of 0.5 ml solvent, each in 3 ml Type I glass vials closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap, 10 applicators, 10 syringes with needle.
Maltese: In-natura u l-għamla tal-ewwel ippakkjar Kull pakkett ta' Equilis StrepE: 10 fjali bil-lijofilizzat u 10 fjali b'0.5ml ta' solvent, kull wieħed minn dawn huwa fjala tal-ħġieġ, Tip I ta' 3ml, magħluqa b'tapp tal-gomma u ssiġillat b'kappa talaluminjum b'kodiċi fuqha, 10 applikaturi 10 siringi bil-labra.
English: Live deletion mutant Streptococcus equi strain TW928 109.0 to 109.4 cfu
Maltese: Deletion mutant ħaj ta' Streptococcus equi strejn TW928 10
English: The vaccine strain is sensitive to penicillins, tetracyclines, macrolides and lincomycin.
Maltese: L-istrejn tal-vaċċin huwa sensittiv għal peniċillin, tetraċiklini, makrolidi u linkomiċin.
English: Intervet International B.V. Wim de Körverstraat 35 NL - 5831 AN Boxmeer The Netherlands
Maltese: NL - 5831 AN Boxmeer Olanda
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Maltese: KWANTITÀTAS-SUSTANZA ATTIVA
English: Overdose (symptoms, emergency procedures, antidotes):
Maltese: Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti) jekk ikun hemm bżonn
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA U MANIFATTUR RESPONSABBLI
English: Lyophilisate: Store in a refrigerator (2 °C - 8 °C).
Maltese: Aħżen fil-friġġ (2°C - 8°C).
English: After reconstitution use within 4 hours.
Maltese: {xahar / sena} Wara li jitħallat uża f'ħin ta' 4 sigħat.
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 jaqgħux taħt l-iskop tar-Regolament (EC) No 470/2009 meta użati f'dan il-prodott mediċinali veterinarju.
English: Withdraw 0.2 ml of the reconstituted vaccine into the syringe provided (see Figure 1) and connect the applicator to the needle (see Figure 2).
Maltese: 2ml mit-tilqim imħallat, ġos-siringa pprovduta (ara immaġni 1 u qabad l-applikatur mal-labra (ara immaġni 2).
English: This product contains a live bacterial deletion mutant with a limited growth potential in mammalian tissue.
Maltese: Dan il-prodott fih deletion mutant b'kapaċità limitata ta' tkabbir f'tessut mammiferu.
English: In rare cases, inappetence, fever, shivering and diffuse oedematous swellings (e.g. facial oedema, swollen muzzle/upper lip) may be observed.
Maltese: F'każijiet rari ħafna jista' jiġi osservat nuqqas t'aptit, deni u tertir u nefħiet b'edema diffusi (eż.edema fil-wiċċ, geddum/xufftejn minfuħin) .
English: Pharmacotherapeutic group: immunological for equidae, live bacterial vaccine, ATCvet code: QI05AE.
Maltese: Kodici ATC veterinarja QI05AE
English: TARGET SPECIES Horses.
Maltese: Kompetenti tal-pajjiż.
English: Excipients:
Maltese: Lijofilizzat:
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata fuq dan il-prodott veterinarju mediċunali tinstab fuq il-websajt tal-Aġenzija Ewropeja tal-Mediċini (ema) http://www.ema.europa.eu
English: Lyophilisate: off-white or cream coloured pellet Solvent: clear colourless solution
Maltese: Lijofilizzat: pelit offwajt jew kannella ċara Solvent: soluzzjoni ċara bla kulur
English: Furthermore, an increase in rectal temperature up to 2.5 °C may occur on the day of vaccination.
Maltese: Barra minn hekk, jista' jkun hemm żieda sa 2.5oC fit-temperatura tal-warrani,
English: An additional antibiotic treatment should be considered for safety reasons.
Maltese: Trattament addizzjonali t'antibijotiċi għandu jkun ikkunsidrat, għal raġunijiet ta' sigurtà.
English: ROUTE OF ADMINISTRATION For submucosal use.
Maltese: MOD TA' AMMINISTRAZZJONI Għal użu fis-submukoża
English: Shelf life after reconstitution according to directions: 4 hours.
Maltese: Data tal-aħħar tiġdid: 10.
English: Do NOT shake.
Maltese: PERJODU TA' TIŻMIM
English: PACKAGE LEAFLET FOR: Equilis StrepE, lyophilisate and solvent for suspension for injection, for horses
Maltese: Equilis StrepE, lijofilizzat u solvent, għal suspensjoni għal-injezzjoni.
English: Aseptically reconstitute the lyophilisate with 0.3 ml of the sterile solvent provided.
Maltese: B'mod asettiku, żid il-lijofilizzat ma' 0.3ml tas-solvent sterili pprovdut.
English: QUANTITY OF THE ACTIVE SUBSTANCE Live Streptococcus equi.
Maltese: Streptococcus equi ħaj
English: DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION Submucosal vaccination of 0.2 ml of reconstituted product.
Maltese: .9 Doża rakkomandata u l-metodu ta' amministrazzjoni Tilqima fis-submukoża b'0.2ml tal-prodott imħallat.
English: Marketing authorization holder and manufacturer responsible for batch release: Intervet International B.V.
Maltese: L-ENTITÀ LI GĦANDHA L-AWTORIZZAZZJONI TAL-KUMMERĊ Intervet International B.V.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For administration submucosally to the inside of the upper lip. Read the package leaflet before use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Għall-amministrazzjoni fis-submukoża, in-naħa ta' ġewwa tax-xoffa ta' fuq.
English: BATCH NUMBER Batch {number}
Maltese: OĦRA, JEKK MEĦTIEĠ
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKAMENT ATTIVA U L
English: Name and address of the manufacturer of the biological active substance Intervet International B.V.
Maltese: U L-INDIRIZZ TAS-SID TAL-AWTORIZZAZZJONI TAL-KUMMERĊ Intervet International B.V.
English: This product contains a live auxotrophic deletion mutant Streptococcus equi vaccine strain with attenuated virulence.
Maltese: Immunizzazzjoni għaż-żwiemel kontra Streptococcus equi biex tnaqqas is-sinjali kliniċi u li joħorġu nefħiet bil-materja fl-għoqod tal-limf.
English: Vaccination scheme:
Maltese: Grupp farmakoterapwetiku:
English: Restrain the animal's head, lift the upper lip and insert the needle into the inside of the upper lip until the applicator rests on the lip. Administer the whole contents of the syringe into the inside of the upper lip (see Figure 3).
Maltese: Wara t-tilqima, reazzjoni li tinħass bħala nefħa mifruxa li tista' tkun sħuna u tuża', tiżviluppa fil-post tal-injezzjoni f'ħin ta' erba' sigħat.
English: WITHDRAWAL PERIOD Zero days.
Maltese: Kull doża ta' 0.
English: EXPIRY DATE EXP: {month/year}
Maltese: DOŻA GĦAL KULL SPEĊI, MOD(I)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis StrepE, lyophilisate and solvent for suspension for injection, for horses
Maltese: Equilis StrepE, lijofilizzat, għal suspensjoni għal injezzjoni, għaż-żwiemel
English: It is able to multiply locally at the submucosal injection site during a short period and is shed into the oro-nasal cavity during a few days, but the vaccine strain does not survive on the oro-nasal mucosa and does not dissiminate systemically at the recommended dose.
Maltese: Dan il-prodott fih strejn tal-vaċċin Streptococcus equi, li hu oksotrofik deletion mutant ħaj li l kapaċitajiet li jagħmel il-ħsara ġew imwaqqfa.
English: PARTICULARS TO APPEAR ON THE INNER BOX WITH LYOPHILISATE
Maltese: PREKAWZJONIJIET SPEĊJALI GĦALL-ĦAŻNA
English: In very rare cases depression may develop.
Maltese: F'każi rari ħafna tista' tiżviluppa dipressjoni.
English: The vaccine organism may establish a small suppurative inflammation locally at the injection site, leading to a disruption of the overlaying lip mucosa and subsequent discharge fluid and inflammatory cells.
Maltese: Kura anti-inflammatorja hija indikata, anke jekk ġie injettat ammont żgħir ħafna ta' prodott.
English: DATE OF FIRST AUTHORISATION Date of first authorization: 07.05.2004 Date of last renewal: 10.04.2014
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 07.
English: PACKAGE SIZE 10 x 1 dose TARGET SPECIES
Maltese: 10 x 1 doża SPEĊI GĦAL XIEX HUWA INDIKAT IL-PRODOTT
English: EMA/337860/2014 EMEA/H/C/002782
Maltese: EMEA/H/C/002782
English: Entyvio is given as an infusion that lasts 30 minutes.
Maltese: Entyvio jingħata bħala infużjoni li ddum 30 minuta.