FrancophonIA/ELRC3.0 huggingface dataset:
English: - Haemorrhagic urinary disorders, further to prostate surgery or surgical procedures affecting the urinary tract, - Ear Nose Throat surgery (adenoidectomy, tonsillectomy, dental extractions), - Gynaecological surgery or disorders of obstetric origin, - Thoracic and abdominal surgery and other major surgical intervention such as cardiovascular surgery, - Management of haemorrhage due to the administration of a fibrinolytic agent.
Maltese: - Emorraġija kkaġunata minn fibrinoliżi ġenerali jew lokali bħal: - Menorraġija u metrorraġija, - Tnixxija tad-demm mis-sistema gastrointestinali, - Disturbi fis-sistema urinarja b'emorraġija, wara operazzjoni fuq il-prostata jew proċeduri kirurġiċi li jaffettwaw is-sistema urinarja, - Operazzjonijiet fuq il-widna, l-imnieħer u l-griżmejn (tneħħija tal-adenojdi, tneħħija tattunsilli, kirurġija dentali) - Operazzjonijiet ġinekoloġiċi jew disturbi ta' oriġini ostetrika, - Operazzjonijiet fil-kaxxa tas-sider u fiż-żaqq u intervenzjonijiet kirurġiċi maġġuri oħra bħal kirurġija fis-sistema kardjovaskulari, - Maniġġjar ta' emorraġija minħabba amministrazzjoni ta' sustanza fibrinolitika.
English: Acute venous or arterial thrombosis (see section 4.4 Special) Fibrinolytic conditions following consumption coagulopathy except in those with predominant activation of the fibrinolytic system with acute severe bleeding (see section 4.4) Severe renal impairment (risk of accumulation)
Maltese: • Kundizzjonijiet fibrinolitiċi li jseħħu wara consumption coagulopathy ħlief f'pazjenti li għandhom attivazzjoni predominanti tas-sistema fibrinolitika bi tnixxija akuta severa taddemm (ara sezzjoni 4.4)
English: - Convulsions particularly in case of misuse (refer to sections 4.3 and
Maltese: - Aċċessjonijiet speċjalment fil-każ ta' użu ħażin (irreferi għal sezzjonijiet 4.3 u 4.4)
English: Tranexamic acid does not bind to serum albumin.
Maltese: Tranexamic acid ma jingħaqadx mal-albumin fis-serum.
English: Within each system organ class, adverse reactions are ranked by frequency.
Maltese: F'kull sistema tal-klassifika tal-organi, ir-reazzjonijiet avversi huma kklassifikati skont il-frekwenza.
English: <Tranexamic acid - containing medicinal products> contains tranexamic acid which belongs to a group of medicines called antihaemorragics; antifibrinolitics, aminoacids.
Maltese: Il-prodotti mediċinali li fihom tranexamic acid fihom tranexamic acid li jappartjeni għal grupp ta' mediċini magħrufa bħala antiemoraġiċi, antifibrinolitiċi, aminoaċidi.
English: Adverse reactions reported are presented in table below.
Maltese: Reazzjonijiet avversi li ġew irraportati huma ppreżentati fit-tabella hawn taħt.
English: Literature review identified 12 efficacy studies in paediatric cardiac surgery which have included 1073 children, 631 having received tranexamic acid.
Maltese: Reviżjoni tal-letteratura wera 12-il studju dwar l-effikaċja f'kiruġija tal-qalb fi tfal li jinkludi 1073 tfal, li minnhom 631 ġew mogħtija tranexamic acid.
English: Following administration of an intravenous injection of 10 mg/kg to 12 pregnant women, the concentration of tranexamic acid in serum ranged 10-53 μg/mL while that in cord blood ranged 4-31 μg/mL.
Maltese: Wara l-amministrazzjoni ta' injezzjoni fil-vina ta' 10mg/kg lil 12-il mara tqila, il-konċentrazzjoni ta' tranexamic acid fis-serum varjat bejn 10-53 μg/ml waqt li dik fid-demm tal-kurdun varjat bejn 4-31 μg/ml.
English: Limited clinical of the use of tranexamic acid in different clinical haemorrhagic settings during the second and third trimesters did not identify deleterious effect for the foetus.
Maltese: Meta kien hemm użu kliniku limitat ta' tranexamic acid f'sitwazzjonijiet kliniċi differenti ta' emorraġija waqt it-tieni u ttielet trimestru ma nstabux effett ħżiena fuq il-fetu.
English: - Menorrhagia and metrorrhagia,
Maltese: - Żomm dan il-fuljett.
English: Dose IV
Maltese: Kull 24 siegħa
English: Nervous system disorders Not known
Maltese: Disturbi fis-sistema nervuża
English: • are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6)
Maltese: • allerġiku għal tranexamic acid jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis sezzjoni 6)
English: Skin and subcutaneous tissue disorders
Maltese: - Sensitività eċċessiva li tinkludi anafilassi
English: Epileptogenic activity has been observed in animals with intrathecal use of tranexamic acid.
Maltese: Attività epilettoġenika ġiet osservata f'annimali li ġew mogħtija tranexamic acid b'mod intratekali.
English: - Diarrhoea - Vomiting - Nausea
Maltese: - Dijarea - Rimettar - Dardir
English: <Tranexamic acid - containing medicinal products>
Maltese: Prodotti mediċinali li fihom Tranexamic acid
English: However, data on efficacy, posology and safety for these indications are limited.
Maltese: Madanakollu, dejta fuq l-effikaċja, posoloġija u s-sigurtà għal dawn l-indikazzjonijiet hija limitata.
English: Uncommon (may affect 1 to 10 in 1000 users) • effects on the skin problems : rash
Maltese: Mhux komuni (jista' jaffettwaw minn 1 sa 10 utenti minn kull 1000 utent)
English: Elimination half-life of tranexamic acid is approximately 3 hours
Maltese: Il-half-life tal-eliminazzjoni ta' tranexamic acid hija ta' madwar 3 sigħat.
English: NAME OF THE MEDICINAL PRODUCT Tranexamic acid containing medicinal products [See Annex I - To be completed nationally]
Maltese: Prodotti mediċinali li fihom Tranexamic acid [Ara anness I - biex titkompla fil-pajjiż partikolari]
English: The plasma protein binding of tranexamic acid is about 3% at therapeutic plasma levels and seems to be fully accounted for by its binding to plasminogen.
Maltese: L-għaqda bejn il-proteini fil-plażma u tranexamic acid hija ta' madwar 3% fil-livell terapewtiku filplażma u dan jidher li hu spjegat kompletament bl-irbit tiegħu mal-plasminogen.
English: Following administration of an intravenous injection of 10 mg/kg to 17 patients undergoing knee surgery, concentrations in the joint fluids were similar to those seen in corresponding serum samples.
Maltese: Wara amministrazzjoni ta' injezzjoni fil-vina ta' 10mg/kg lil 17-il pazjent li kienu għaddejjin minn operazzjoni fl-irkoppa, il-konċentrazzjonijiet fl-ilma ta' madwar ilġogi kienu simili għal dawk osservati f'kampjuni ekwivalenti tas-serum.
English: In renal insufficiency leading to a risk of accumulation, the use of tranexamic acid is contraindicated in patient with severe renal impairment (see section 4.3).
Maltese: F'każijiet ta' insuffiċjenza renali li jistgħu jwasslu għal riskju ta' akkumulazzjoni, l-użu ta' tranexamic acid huwa kontra-indikat f'pazjenti b'indeboliment renali serju (ara sezzjoni 4.3).
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ [Biex titkompla fil-pajjiż partikolari]
English: With continuous long-term use of TXA solution for injection, regular ophthalmologic examinations (eye examinations including visual acuity, colour vision, fundus, visual field etc.) are indicated.
Maltese: • Meta jkun hemm użu kontinwu u fit-tul ta' prodotti mediċinali li fihom Tranexamic acid soluzzjoni għal injezzjoni , wieħed għandu jagħmel viżti oftalmoloġiċi regulari (eżamijiet talgħajnejn inkluż akutezza viżiva, il-viżjoni bil-kulur, fundus, kamp viżiv eċċ).
English: Before use of TXA, risk factors of thromboembolic disease should be considered.
Maltese: TXA, għandhom jiġu kkunsidrati r-riskji li jkun hemm mard tromboembolitiku.
English: Studied population was heterogenic in terms of age, surgery types, dosing schedules.
Maltese: Il-popolazzjoni li ġiet studjata kienet eteroġena f'termini ta' età, it-tip ta' kirurġija u skedi ta' dożaġġ.
English: Currently available data are limited and are described in section 5.1.
Maltese: Id-dejta li hawn disponibbli hija limitata u hija deskritta f'sezzjoni 5
English: Tranexamic acid exerts an anti haemorrhagic activity by inhibiting the fibrinolytic properties of plasmin.
Maltese: Tranexamic acid għandu effett kontra l-emorraġija billi jinibixxi il-karatteristiċi fibrinolitiċi talplasmin.
English: Haematuria In case of haematuria from the upper urinary tract, there is a risk for urethral obstruction.
Maltese: Ematurja F'każijiet ta' ematurja mis-sistema urinarja ta' fuq, hemm riskju li l-uretra timblokka.
English: Pregnancy and breast-feeding
Maltese: L-użu fl-adulti
English: Tranexamic acid passes through the placenta.
Maltese: Tranexamic acid jgħaddi mill-plaċenta.
English: Convulsions
Maltese: Komuni
English: 6.1 List of excipients [To be completed nationally]
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna [Biex titkompla fil-pajjiż partikolari]
English: Study results with tranexamic acid suggest reduced blood loss and reduced blood product requirements in paediatric cardiac surgery under cardiopulmonary bypass (CPB) where there is a high risk of haemorrhage, especially in cyanotic patients or patients undergoing repeat surgery.
Maltese: Ir-riżultati tal-istudju bi tranexamic acid jissuġġerixxu tnaqqis fit-telf tad-demm u tnaqqis fil-bżonn ta' prodotti tad-demm f'operazzjonijiet tal-qalb fit-tfal li kellhom bypass kardjopulmonari (CPB) fejn hemm riskju kbir ta' emorraġija, speċjalment f'pazjenti li m'għandhomx biżżejjed ossiġinazzjoni tad-demm jew pazjenti li għaddejjin minn kirurġija repetuta.
English: • If you have had blood in your urine <Tranexamic acid - containing medicinal products> it may be lead to urinary tract obstruction.
Maltese: • Jekk kellek demm fl-urina, prodotti li fihom tranexamic acid jistgħu jikkaġunaw imblukkar fis-sistema urinarja.
English: - Keep this leaflet.
Maltese: • għandek storja ta' aċċessjonijiet.
English: Paediatric Population:
Maltese: Kategorija farmakoterapewtika:
English: In such acute cases a single dose of 1g tranexamic acid is frequently sufficient to control bleeding.. Administration of Tranexamic acid in DIC should be considered only when appropriate haematological laboratory facilities and expertise are available.
Maltese: F'każijiet akuti simili doża waħda ta' 1g tranexamic acid hija ħafna drabi biżżejjed biex tikkontrolla t-tnixxija tad-demm.
English: While studied in very few patients, the limited data suggest that continuous infusion is preferable, since it would maintain therapeutic plasma concentration throughout surgery.
Maltese: Għalkem ġie studjat f'numru żgħir ħafna ta' pazjenti, id-dejta limitata tindika li infużjoni kontinwa hija preferibbli, għax din iżżomm il-konċentrazzjoni terapewtika fil-plażma waqt il-kirurġija.
English: Patients with disseminated intravascular coagulation (DIC) should in most cases not be treated with tranexamic acid (see section 4.3).
Maltese: Pazjenti b'koagulazzjoni intravaskulari mxerrda (DIC) fil-biċċa l-kbira tal-każijiet m'għandhomx jiġu trattati bi tranexamic acid (ara sezzjoni 4.3).
English: Prevention and treatment of haemorrhages due to general or local fibrinolysis in adults and children from one year.
Maltese: Prevenzjoni u kura tal-emorraġiji kkaġunati minn fibrinoliżi ġenerali jew lokali fl-adulti u fit-tfal minn sena 'l fuq.
English: Use in patients with kidney problem
Maltese: L-użu f'pazjenti bi problemi fil-kliewi
English: Special populations
Maltese: Pożoloġija Adults
English: ILT: 4 weeks, MD: 9 days.
Maltese: ILT: 4 ġimgħat MD: 9 tijiem
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 03/07/2015
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 03/07/2015
English: Store and transport frozen in liquid nitrogen (-196 °C).
Maltese: Aħżen u trasporta friżati fin-nitroġenu likwidu (-196 °C).
English: Do not use chemical disinfectants.
Maltese: Tużax diżinfettanti kemikali.
English: Pancreatic digest of casein Phenolsulfonphthalein (Phenol red) Potassium dihydrogen phosphate Water for injections
Maltese: Diġest pancreatic tal- casein Phenolsulfonphthalein (Phenol red) Potassium dihydrogen phosphate
English: MARKETING AUTHORISATION NUMBER(S) EU/2/15/182/001
Maltese: FIS-SUQ EU/2/15/182/001
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer THE NETHERLANDS
Maltese: Wim de Körverstraat 35 5831 AN Boxmeer L-OLANDA
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) HVT/ILT-138
Maltese: HVT/ILT-138
English: Store below 25 °C.
Maltese: Aħzen taħt 25 °C.
English: 5 bags of 400 ml solvent or 5 bags of 800 ml solvent.
Maltese: 5 boroż ta' 400ml solvent u 5 boroż ta' 800ml solvent.
English: - 400 ml polyethylene or multilayer plastic bags of solvent.
Maltese: - 400ml polyethylene jew boroż multilayer tal-plastik tas-solvent.
English: - 800 ml polyethylene or multilayer plastic bags of solvent.
Maltese: - 800ml polyethylene jew boroż multilayer tal-plastik tas-solvent.
English: Onset of immunity:
Maltese: Bidu tal-immunita`:
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: Cell-associated live recombinant turkey herpesvirus (strain HVT/ILT-138), expressing the glycoproteins gD and gI of infectious laryngotracheitis virus:
Maltese: Herpesvirus rikombinant ħaj cell-associated tad-dundjan (strejn HVT/ILT-138) li jesprimi ilglycoproteini gD u gI tal-virus infettiv laryngotracheitis:
English: 5 ampoules, each containing 2,000 or 4,000 doses of cell suspension (attached to the cane is a coloured clip displaying the dose; 2,000 doses: salmon-pink coloured clip, and 4,000 doses: yellow coloured clip).
Maltese: 5 ampulli, li fihom 2,000 jew 4,000 doża ta' suspensjoni taċ-ċelloli (mwaħħal mal-basket hemm klippa kkulurita li turi d-doża (2,000 dożi: klippa kulur roża salamun u l-4,000 doża: klippa safra).
English: Chickens.
Maltese: Tiġieġ .
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Innovax-ILT, suspension and solvent for suspension for injection for chickens
Maltese: VETERINARJU Innovax-ILT suspensjoni u solvent għal suspensjoni għall- injezzjoni għat- tiġieġ
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Innovax-ILT
Maltese: Innovax-ILT
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Maltese: IL-KLIEM "GĦALL-KURA TAL-ANNIMALI BISS” For animal treatment only.
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: Skont l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, kif emendata, Stat Membru jista, skont il-liġijiet nazzjonal tiegħu, jipprojbixxi il-manifattura, l-importazzjoni, ilpussess, il-bejgħ, il-forniment u/jew l-użu ta' prodotti mediċinali veterinarji immunoloġiċi fit-territorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: Use 400 ml of solvent for each 2,000 doses of cell suspension or 800 ml of solvent for each 4,000 doses of cell suspension.
Maltese: Uża 400ml tas-solvent għall-kull 2,000 doża ta'suspensjoni ta' ċelloli jew 800ml tas-solvent għall-kull 4,000 doża ta'suspensjoni ta' ċelloli.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 400 ml
Maltese: PIŻ, VOLUM JEW NUMRU TA' DOŻI 400 ml
English: Pack sizes:
Maltese: Posoloġija:
English: Pharmacotherapeutic group: immunologicals for Aves, live viral vaccines for domestic fowls.
Maltese: Grupp farmako-terapewtiku: immunoloġiku tat-tjur, vaċċin ta' virus ħaj għall-għasafar domestiċi Kodici ATĊ veterinarja:
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 ikunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta wżati bħal f'dan il-prodott mediċinali veterinarju.
English: Gently withdraw the contents of the ampoule into a sterile syringe, mounted with an 18 gauge needle.
Maltese: Iġbed bil-mod il-kontenut tal-ampulla f'siringa sterili li għabdha labbra 18 gauge.
English: For this reason, thaw the ampoules in clean water at 25-27 °C.
Maltese: Għal din irraġuni ħoll l-ampull f' ilma nadif bejn 25 - 27°C.
English: For active immunization of one-day-old chicks to reduce mortality, clinical signs and lesions due to infection with avian infectious laryngotracheitis (ILT) virus and Marek's disease (MD) virus.
Maltese: Għall-immunita` attiva tal-flieles ta' ġurnata sabiex inaqqas l-imwiet, sinjali kliniċi u lesjonijiet minħabba infezzjoni bil-virus infettiv tal-għasafar laryngotracheitis (ILT) u l-virus tal-Marek`s disease (MD).
English: The solvent must be clear, red coloured, without sediment and at room temperature (15-25 °C) at the time of mixing
Maltese: Is-solvent irid ikun ċar, kulur aħmar, mingħajr sediment u f'temperatura tal-kamra (15-25°C) filħin li jiġi mħallat.
English: The vaccine induces active immunity against infectious laryngotracheitis and Marek's disease in chickens.
Maltese: Il-vaċċin jinduċi immunita` attiva kontra laryngotracheitis u l-marda ta' Marek fit-tiġieġ.
English: Control of correct storage:
Maltese: Kontroll ta' ħażna koretta:
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day, but not mixed with, Nobilis ND Clone 30 or Nobilis ND C2.
Maltese: Hemm informazzjoni dwar is-sigurtà u l-effikaċja li turi li dan il-vaċċin jista' jiġi amministrat fl-istess ġurnata, iżda mhux imħallat man-Nobilis ND Clone 30 jew Nobilis ND C2.
English: When this product is mixed with Nobilis Rismavac, both should be diluted in the same solvent bag in the same way (400 ml of solvent for each 2,000 doses of both products or 800 ml of solvent for each 4,000 doses of both products).
Maltese: Meta dan il-prodott jiġi mħallat man-Nobilis Rismavac, it-tnejn għandhom jiġu dilwiti fl-istess borża tas-solvent fl-istess manjiera (400ml tas-solvent għall-kull 2,000 doża taż-żewġ prodotti u 800ml 400ml tas-solvent għall-kull 4,000 doża taż-żewġ prodotti
English: Safety trials have shown that the strain is safe for turkeys.
Maltese: Provi fuq is-sigurta wrew li l-istrejn huwa sikur fid-dundjani.
English: Disinfect vaccinating equipment by boiling in water for 20 minutes or by autoclaving (15 minutes at 121 °C).
Maltese: Iddiżifetta l-apparat tal-vaċċinazzjoni billi tgħalli fl-ilma jbaqbaq għall-20 minuta jew bl-‘autoclaving' (15 il-minuta f` 121°C).
English: PACKAGE LEAFLET: Innovax-ILT suspension and solvent for suspension for injection for chickens
Maltese: Innovax-ILT suspensjoni u solvent għal suspensjoni għall- injezzjoni għat- tiġieġ
English: The vaccine is a cell-associated live recombinant turkey herpesvirus (HVT) expressing the gD and gI glycoproteins of infectious laryngotracheitis virus.
Maltese: Herpes virus rikombinant ħaj cell-associated tad-dundjan (strejn HVT/ILT-138) li jesprimi ilglycoproteini gD u gI tal-virus infettiv laryngotracheitis:
English: The manufacture, import, possession, sale, supply and/or use of Innovax-ILT 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, il-bejgħ, il-provvista u/jew l-użu ta' Innovax-ILT huwa pprojbit jew jista' jkun ipprojbit f'ċertu Stati Membri fit-territorju kollu tagħhom jew f'parti minnu taħt leġizlazzjoni nazzjonali.
English: Shelf life after reconstitution according to directions: 2 hours at a temperature below 25 °C.
Maltese: 2 snin Żmien kemm idum tajjeb wara li jitħallat skond kif indikat: sagħtejn f'temperatura taħt 25 °C.
English: PHARMACEUTICAL FORM Suspension and solvent for suspension for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni u solvent għal suspensjoni għall-injezzjoni għat-tiġieġ.
English: It is important that the suspension, after being thawed, is mixed immediately into the solvent to protect the cells.
Maltese: Huwa mportanti li s-suspensjoni, wara li tiġi mħolla, tiġi mħallta immedjatament mas-solvent sabiex tipproteġi ċ-ċelloli.
English: The bag of vaccine should be gently swirled frequently during vaccination to guarantee that the vaccine suspension remains homogenous and that the correct vaccine virus titre is administered (e.g. during long vaccination sessions).
Maltese: Il-borża tal-vaċċin għanda tiġi frekwentament mdawwra waqt il-vaċċinazzjoni sabiex tiggarantixxi li lsuspensjoni tal-vaċċin tinqa ħomoġenja u li t-tajter korrett ta' virus huwa amministrat (e.ż. waqt sessjonijiet twal ta' vaċċinazzjoni).
English: (number of doses per ampoule is presented on the colour coded clip attached to each cane containing the ampoule)
Maltese: (numru ta' dożi kull ampulla hija presentata fuq il-klippa kodifikat b'kulur mwaħħla ma kull baskett (cane) li fih l-ampulla)
English: Do not mix with any other veterinary medicinal product except Nobilis Rismavac and the solvent supplied for use with the veterinary medicinal product.
Maltese: Tħallatx ma ebda prodott mediċinali veterinarju ieħor ħlief man-Nobilis Rismavac u s-solvent provdut għal użu ma dan il-prodott mediċinali veterinarju.
English: Innovax-ILT is a virus suspension packed in glass ampoules and stored in liquid nitrogen.
Maltese: Innovax-ILT huwa suspensjoni tal-virus ippakjat f`ampulla tal-ħġieġ u maħżuna fin-notroġenu likwidu.
English: The content of the ampoule(s) is thawed rapidly by immersing in clean water at 25-27 °C.
Maltese: Il-kontenut tal-ampulla(i) għandu jiġi mħolli malajr billi tniżżel fl-ilma nadif bejn 25 - 27°C.
English: Suspension: off-red to red suspension.
Maltese: Suspensjoni: suspensjoni kważi ħamra għal ħamra.
English: Any person intending to manufacture, import, possess, sell, supply and/or use Innovax-ILT 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 għandha l-ħsieb li timmanifattura, timporta, tieħu pussess, tbiegħ, tipprovdi u/jew tuża Innovax-ILT għandha tikkonsulta ma' l-Awtorità Kompetenti ta' l-Istat Membru dwar il-programmi ta' tilqim fis-seħħ qabel ma timmanifattura, timporta, tieħu pussess, tbiegħ, tipprovdi u/jew tuża.
English: Subcutaneous use.
Maltese: AMPULLA ISEM
English: Use solvent (Solvent for cell associated poultry vaccines) for reconstitution.
Maltese: Uża solvent ( Solvent għall-vaċċin ta`ċelloli assoċjati mat-tjur.)għar-rikostituzzjoni.
English: For this mixed use, an onset of immunity of 5 days has been demonstrated for MD.
Maltese: Għall-dan l-użu mħallat, bidu tal-immunita` ta' 5 ijiem ġiet murija għall-MD.
English: WITHDRAWAL PERIOD Zero days.
Maltese: Injezzjoni waħda ta' 0.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (0.2 ml) of reconstituted vaccine contains:
Maltese: U INGREDJENT(I) OĦRA Kull doża (0.2ml) tal-vaċċin rikostitwit fiha:
English: There is no information available on the number of doses on the ampoules once they are removed from the cane, so special care has to be taken to ensure that the mix-ups of ampoules with different number of doses is avoided and the correct solvent is used.
Maltese: Huwa mportanti li s-suspensjoni, wara li tiġi mħolla (thawed), tiġi mħallta immedjatament mas-solvent sabiex tipproteġi iċ-ċelloli.
English: Gently swirl the ampoule(s) to disperse the contents.
Maltese: Wara li tneħħi l-ampulla(i) poġġi lura minnufih l-ampulli li jifdal fil-kontenitur tan-niroġenu likwidu.
English: CAUTION: Ampoules have been known to explode on sudden temperature changes.
Maltese: Huwa magħruf li lampulli jistgħu jisplodu f'tibdil f'daqqa tat-temperatura.
English: Contains mannitol and aspartame.
Maltese: Fiha mannitol u aspartame.
English: Neoclarityn contains lactose
Maltese: Neoclarityn fih lactose