FrancophonIA/ELRC3.0 huggingface dataset:
English: In a phase III study, 1218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either docetaxel (T) 75 mg/m as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m over
Maltese: III, 1218-il pazjent li kellhom tumur li ma jistax jitneħħa kiruġikament, kategorija IIIB jew IV NSCLC, b'KPS ta' 70% jew akbar, u li ma rċevewx kimoterapija preċedenti għal din ilkundizzjoni, kienu mqassmin, mingħajr għażla, jew fi ġrupp li ħa it-docetaxel (T) f'doża ta' 75 mg/m2 bħala infużjoni tul siegħa, segwita immedjatament b'cisplatin (Cis) 75 mg/m2 li ngħata fuq perjodu ta'
English: TAXOTERE 80 mg/4 ml concentrate for solution for infusion docetaxel
Maltese: TAXOTERE 80 mg/4 ml konċentrat għall-infużjoni docetaxel
English: Each single-dose vial of TAXOTERE 80 mg/2 ml concentrate contains docetaxel (as trihydrate) corresponding to 80 mg of docetaxel (anhydrous).
Maltese: Kull kunjett b'doża waħda ta' TAXOTERE 80 mg/2 ml, konċentrat, li fih docetaxel (bħala tri-idrat) li jikkorrispondenti għal 80 mg ta' docetaxel (anidru).
English: Cautions for use in adjuvant treatment of breast cancer There are limited data available in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Maltese: Huwa limitat it-tagħrif disponibbli f'pazjenti li ghandhom >70 sena u li kienu fuq docetaxel flimkien ma' doxorubicin u cyclophosphamide.
English: • The solvent for TAXOTERE 20 mg/0.5 ml vial is a 7 ml clear glass vial with a transparent colourless flip-off cap.
Maltese: • Is-solvent għal TAXOTERE 20 mg/0.5 ml huwa f'kunjett tal-ħġieġ ċar ta' 7 ml u li għandu tapp trasparenti u mingħajr kulur, li jinfetaħ billi tgħollih.
English: Tabulated list of adverse reactions in breast cancer for TAXOTERE 100 mg/m² in combination with trastuzumab
Maltese: Lista f'forma tabulari tar-reazzjonijiet avversi fil-kanċer tas-sider għal TAXOTERE 100 mg/m² użat flimkien ma' trastuzumab
English: Docetaxel must not be used in patients with severe liver impairment since there is no data available (see sections 4.2 and 4.4).
Maltese: Docetaxel ma jistax jintuża f'pazjenti b'indeboliment serju tal-fwied għaliex m'hemmx data dwar dan (ara sezzjonijiet 4.2 u 4.4).
English: TAXOTERE in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Maltese: TAXOTERE użat flimkien ma' doxorubicin Studju wieħed kbir fil-fażi
English: What solvent vial contains 13% (w/w) ethanol 95% (see section 2) in water for injections.
Maltese: X'fih il-kunjett ta' solvent 13% (w/w) t'ethanol 95% (ara sezzjoni 2) fl-ilma għall-injezzjonijiet.
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP) Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l interventi meħtieġa ta' farmakoviġilanza ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Pregnancy
Maltese: PREżENTAZZJONI
English: Time to clinical progressionc Median (months) 95% CI
Maltese: Żmien sa kanċer tal-prostata reżistenti għall kastrazzjonib Medjan (xhur) 95% CI
English: Anaemia (G3/4: 6.9%); Thrombocytopenia (G4:
Maltese: Għejja (G3/4: 3.9%); Żamm tal-fluwidu (sever:
English: Dysgeusia (G3/4:
Maltese: Stitikezza (G3/4:
English: OUTER CARTON / TAXOTERE 20 mg/1 ml
Maltese: KAXXA TA' BARRA/TAXOTERE 20 mg/1 ml
English: Weight decreased (G3/4: 0.2%)
Maltese: Arritmija (G3/4: 0.2%)
English: Actavis Group hf. Reykjavíkurvegi 76-78 220 Hafnafjördur Iceland
Maltese: Actavis Group hf Reykjavíkurvegur 76-78 IS-220
English: TEOFARMA Sr Sede legale: via F.lli Cervi, 8 27010 Valle Salimbene (PV) Italy
Maltese: TEOFARMA Sr Sede legale: via F.lli Cervi, 8 27010
English: TEOFARMA Srl Sede legale: via F.lli Cervi, 8 27010 Valle Salimbene (PV) Italy
Maltese: TEOFARMA Srl Sede legale: via F.lli Cervi, 8 27010
English: ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Maltese: LISTA TA` ISMIJIET IVVINTATI, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TALPRODOTTI MEDIĊINALI, MNEJN JINGĦATAW, U D-DETENTURI TA` LAWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI
English: Denmark
Maltese: Spain
English: Member State Marketing Authorisation Holder Invented Name
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-suq
English: Strength
Maltese: Stat Membru
English: Route of Administration
Maltese: Konċentrat għal soluzzjoni għallinfużjoni
English: SC injection.
Maltese: Injezzjoni SC.
English: Poloxamer 188 Sodium chloride Glycine
Maltese: Sodium chloride Glycine
English: Disodium edetate Sodium hydroxide Hydrochloric acid Meglumine Water for injection
Maltese: Disodium edetate Sodium hydroxide Hydrochloric acid Meglumine Ilma għall-injezzjoni
English: The active substance in Novem is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Is-sustanza attiva f'Novem hija sustanza ammissibbli kif deskritt fit-tabella numru 1 fl-anness tarRegolament tal-Kummissjoni (UE) Nru 37/2010:
English: Sodium hydroxide Glycofurol Meglumine Water for injection
Maltese: Sodium hydroxide Glycofurol Meglumine Ilma għall-injezzjoni
English: To obtain the best possible pain relieving effect post-surgery Novem should be administered 30 minutes before surgical intervention.
Maltese: Biex tikseb l-aħjar effett possibbli biex jittaffa l-uġigħ wara operazzjoni, Novem għandu jingħata 30 minuta qabel intervent kirurġiku.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: Manufacturer responsible for batch release: Labiana Life Sciences S.A.
Maltese: Labiana Life Sciences S.A.
English: Vial, 100 ml
Maltese: Kunjett, 100 ml
English: Meloxicam in Novem 5 mg/ml solution for injection for cattle and pigs is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Meloxicam f'Novem 5 mg/ml soluzzjoni għall-injezzjoni għal baqar u majjali hi sustanza ammissibbli kif deskritt fit-tabella numru 1 fl-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010:
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn 10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn 10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: Carton for 20 ml, 50 ml, 100 ml and 250 ml
Maltese: Kartuna għal 20 ml, 50 ml, 250 ml u 100 ml
English: Treatment of calves with Novem 20 minutes before dehorning reduces post-operative pain.
Maltese: Trattament ta' għoġiela b' Novem 20 minuta qabel it-tneħħija tal-qrun inaqqas l-uġigħ ta' wara l operazzjoni.
English: Cattle:
Maltese: Majjali:
English: Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
Maltese: Prodotti anti-infjammatorji u anti-rewmatiċi, mhux sterojdi (oxicams)
English: EXP {month/year} Shelf-life of broached vial: 28 days.
Maltese: La darba jinfetaħ uża fi żmien: 28 jum.
English: Carton for 20 ml, 50 ml and 100 ml
Maltese: Kartuna għal 20 ml, 50 ml u 100 ml
English: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic effects.
Maltese: Meloxicam hu mediċina mhux sterojdi kontra l-infjammazzjoni (NSAID) tal-klassi oxicam li taġixxi bl-inibizzjoni tas-sintesi ta' prostaglandin, u b'hekk teżerċita effetti anti-infjammatorji, kontra ttnixxija, analġesiċi u antipiretiċi.
English: Cattle: SC Pigs:
Maltese: Kodici ATC veterinarja:
English: People with known hypersensitivity to non-steroidal antiinflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Maltese: Nies li huma sensittivi għal Mediċini Mhux Sterojdi Kontra l-Infjammazzjoni (NSAIDs) għandhom jevitaw li jmissu mal-prodott mediċinali veterinarju.
English: Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity.
Maltese: Evita l-użu f'annimali li huma deidratati, ipovolaemiċi jew ipotensivi severament, li jkunu jeħtieġu idratazzjoni mill-ġdid permezz ta' injezzjoni, għax jista' jkun hemm riskju potenzjali ta' tossiċità tal kliewi.
English: Pharmacologi cally active substance
Maltese: Sustanza farmakoloġi kament attiva
English: For the relief of post-operative pain associated with minor soft tissue surgery such as castration.
Maltese: Għas-solliev mill-uġigħ ta' wara l-operazzjoni assoċjat ma' kirurġija minuri fuq tessut artab bħal kastrazzjoni.
English: IM injection.
Maltese: Majjali: Injezzjoni IM.
English: Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATCvet code: QM01AC06
Maltese: Prodotti anti-infjammatorji u anti-rewmatiċi, mhux sterojdiċi (oxicams)
English: Pigs:
Maltese: Baqar:
English: In pigs, after intramuscular administration, the mean plasma elimination half-life is approximately 2.5 hours.
Maltese: Fil-majjali, wara li jingħata b'injezzjoni ġol-muskoli, il-medja tal-half-life ta' l-eliminazzjoni tal plażma hi ta' madwar 2.5 sigħat.
English: One ml contains: Meloxicam 5 mg Ethanol
Maltese: Meloxicam 5 mg Ethanol 150 mg
English: Novem 40 mg/ml solution for injection for cattle
Maltese: VETERINARJU Novem 40 mg/ml soluzzjoni għall-injezzjoni għal baqar
English: Active substance: Meloxicam 5 mg
Maltese: TAS-SUSTANZA(I) ATTIVA(I) Meloxicam 5 mg/ml
English: Meloxicam 20 mg Ethanol
Maltese: Meloxicam 20 mg
English: Meat and offal: 15 days; milk: 5 days.
Maltese: Laħam u ġewwieni tal-annimali: 15-il ġurnata; ħalib: 5 ġranet.
English: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/25 kg body weight).
Maltese: Injezzjoni waħda ġol-muskoli b'dożaġġ ta' 0.4 mg ta' meloxicam/kilogramm ta' piż tal-ġisem (i.e. 0.4 ml/5 kg ta' piż tal-ġisem) qabel l-operazzjoni.
English: Active substance: Meloxicam 20 mg
Maltese: TAS-SUSTANZA(I) ATTIVA(I) Meloxicam 20 mg/ml
English: EU/2/04/042/005 1 x 20 ml EU/2/04/042/003 1 x 50 ml EU/2/04/042/004 1 x 100 ml EU/2/04/042/006 1 x 250 ml EU/2/04/042/011 12 x 20 ml EU/2/04/042/012 12 x 50 ml EU/2/04/042/013 12 x 100 ml EU/2/04/042/014 6 x 250 ml
Maltese: EU/2/04/042/005 1 x 20 ml EU/2/04/042/003 1 x 50 ml EU/2/04/042/004 1 x 100 ml EU/2/04/042/006 1 x 250 ml EU/2/04/042/011 12 x 20 ml EU/2/04/042/012 12 x 50 ml EU/2/04/042/013 12 x 100 ml EU/2/04/042/014
English: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 0.4 ml/5 kg body weight) before surgery.
Maltese: Injezzjoni waħda ġol-muskoli b'dożaġġ ta' 0.4 mg ta' meloxicam/kilogramma ta' piż tal-ġisem (i.e. 0.4 ml/5 kg ta' piż tal-ġisem) qabel l-operazzjoni.
English: EU/2/04/042/001 1 x 100 ml EU/2/04/042/002 12 x 100 ml
Maltese: EU/2/04/042/002 12 x 100 ml
English: EU/2/04/042/005 1 x 20 ml EU/2/04/042/003 1 x 50 ml EU/2/04/042/004 1 x 100 ml EU/2/04/042/006 1 x 250 ml
Maltese: EU/2/04/042/003 1 x 50 ml EU/2/04/042/004 1 x 100 ml EU/2/04/042/006 1 x 250 ml EU/2/04/042/011
English: EU/2/04/042/003 1 x 50 ml EU/2/04/042/004 1 x 100 ml EU/2/04/042/006 1 x 250 ml EU/2/04/042/012 12 x 50 ml EU/2/04/042/013 12 x 100 ml EU/2/04/042/014 6 x 250 ml
Maltese: EU/2/04/042/003 1 x 50 ml EU/2/04/042/004 1 x 100 ml EU/2/04/042/006 1 x 250 ml EU/2/04/042/012 12 x 50 ml EU/2/04/042/013 12 x 100 ml EU/2/04/042/014
English: EU/2/04/042/007 1 x 20 ml EU/2/04/042/009 1 x 50 ml EU/2/04/042/001 1 x 100 ml EU/2/04/042/008 12 x 20 ml EU/2/04/042/010 12 x 50 ml EU/2/04/042/002 12 x 100 ml
Maltese: EU/2/04/042/007 1 x 20 ml EU/2/04/042/009 1 x 50 ml EU/2/04/042/001 1 x 100 ml EU/2/04/042/008 12 x 20 ml EU/2/04/042/010
English: EXP {month/year} Once broached use within 28 days.
Maltese: La darba jinfetaħ, uża fi żmien 28 jum.
English: Single subcutaneous injection at a dose of 0.5 mg meloxicam/kg body weight (i.e. 1.25 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Maltese: U METODU TA' AMMINISTRAZZJONI Injezzjoni waħda taħt il-ġilda, b'doża ta' 0.5 mg ta' meloxicam/kg ta' piż tal-ġisem (i.e. 1.25 ml/100 kg ta' piż tal-ġisem) flimkien ma' terapija antibijotika, jew ma' terapija orali ta' idratazzjoni mill-ġdid, kif ikun xieraq.
English: Novem 40 mg/ml solution for injection for cattle Meloxicam
Maltese: VETERINARJU Novem 40 mg/ml soluzzjoni għall-injezzjoni għal baqar meloxicam
English: Following single intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.1 to 1.5 µg/ml was reached within 1 hour in pigs.
Maltese: Wara l-għoti ta' dożi waħidhom fil-muskoli ta' 0.4 mg ta' meloxicam/kg, intlaħaq valur Cmax ta' 1.1 sa 1.5 µg/ml fi żmien siegħa fil-majjali.
English: Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves and lactating cows.
Maltese: Meloxicam għandu wkoll proprjetajiet anti-endotossiċi għax intwera li jinibixxi l-produzzjoni ta' thromboxane B2 ikkaġunata mill-għoti ta' E. coli endotoxin fl-għoġġiela, baqar li jkunu qed ireddgħu u majjali.
English: PACKAGE LEAFLET: Novem 5 mg/ml solution for injection for cattle and pigs
Maltese: VETERINARJU Novem 5 mg/ml soluzzjoni għall-injezzjoni għall-baqar u l-majjali.
English: Withdrawal periods:
Maltese: Data tal-aħħar tiġdid:
English: EU/2/04/042/011 12 x 20 ml EU/2/04/042/012 12 x 50 ml EU/2/04/042/013 12 x 100 ml EU/2/04/042/014 6 x 250 ml
Maltese: 12 x 20 ml EU/2/04/042/012 12 x 50 ml EU/2/04/042/013 12 x 100 ml EU/2/04/042/014
English: Novem 40 mg/ml solution for injection for cattle meloxicam
Maltese: VETERINARJU Novem 40 mg/ml għall-injezzjoni għall-baqar meloxicam
English: Equidae
Maltese: KWANTITÀ
English: After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 µg/ml were reached after 7.7 hours in young cattle.
Maltese: Wara l-għoti ta' doża waħda taħt il-ġilda ta' 0.5 mg ta' meloxicam/kg, intlaħqu valuri Cmax ta' 2.1 µg/ml wara 7.7 sigħat f'baqar żgħar.
English: 4.11 Withdrawal periods
Maltese: 4.11 Perjodi ta' tiżmim
English: PACKAGE LEAFLET: Novem 20 mg/ml solution for injection for cattle and pigs
Maltese: VETERINARJU Novem 20 mg/ml soluzzjoni għall-injezzjoni għall-baqar u majjali
English: Excipient: Ethanol
Maltese: Speċe tal annimal
English: Withdrawal period:
Maltese: Sustanza attiva:
English: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate.
Maltese: Majjali: Injezzjoni waħda fil-muskolu b'dożaġġ ta' 0.4 mg ta' meloxicam / kg ta' piż tal-ġisem (i.e. 2.0 ml/100 / kg ta' piż tal-ġisem) flimkien ma' terapija antibijotika, kif ikun xieraq.
English: In view of the risk of accidental self-injection and the known adverse class-effects of NSAIDs and other prostaglandin inhibitors on pregnancy and/or embryofoetal development, the veterinary medicinal product should not be administered by pregnant women or women attempting to conceive.
Maltese: Minħabba r-riskju li tinjetta lilek innifsek b'mod aċċidentali u l-effetti avversi magħrufa tal-klassi ta' NSAIDs u inibituri oħrajn ta' prostaglandin fuq it-tqala u/jew l-iżvilupp embrijofetali, il-prodott mediċinali veterinarju m' għandux jingħata minn nisa tqal jew minn nisa li jkun qed jippruvaw joħorġu tqal.
English: Subcutaneous and intramuscular injection is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.
Maltese: Fin-nuqqas ta' studji dwar kompatibilità, dan il-prodott mediċinali veterinarju ma jistax jintuża flimkien ma' prodotti mediċinali veterinarji oħra.
English: Special precautions for use in animals:
Maltese: U METODU TA' AMMINISTRAZZJONI Baqar:
English: meat and offal: 15 days
Maltese: Laħam u ġewwieni tal-annimali: 15-il ġurnata;
English: Single subcutaneous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Maltese: Injezzjoni waħda taħt il-ġilda b'dożaġġ ta' 0.5 mg ta' meloxicam / kg ta' piż tal-ġisem (i.e. 2.5 ml/100 kg ta' piż tal-ġisem) flimkien ma' terapija antibijotika, jew ma' terapija orali ta' idratazzjoni mill-ġdid, skond kif ikun xieraq.
English: Active substance: Meloxicam
Maltese: Meloxicam Meloxica m
English: Withdrawal periods: Meat and offal: 15 days; milk: 5 days.
Maltese: PERJODU TA' TIŻMIM Laħam u ġewwieni tal-annimali: 15-il ġurnata; ħalib: 5 ġranet.
English: Expiry date
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: MA (EU) Number
Maltese: Numru MA (EU)
English: (Invented) name
Maltese: (Ivvintat) isem
English: To stimulate active immunity against Bordetella bronchiseptica.
Maltese: Sabiex tkun stimulata immunita attiva kontra Bordetella bronchiseptica.
English: Date of last renewal: 30/08/2012
Maltese: Data tal-ewwel awtorizzajoni: 10-09-2002 Data tal-aħħar tiġdid: 30/08/2012
English: ATC vet code: QI06AE02
Maltese: Kodiċi ATC veterinarja QI 06AE02
English: Cats.
Maltese: Biss.
English: Phosphate buffers.
Maltese: Baffers tal-fosfat.
English: Sorbitol
Maltese: Ġelatina, Sorbitol,
English: Intervet International B.V. Wim de Körverstraat 35 NL - 5831 AN Boxmeer The Netherlands
Maltese: Wim de Körverstraat 35 NL - 5831 AN Boxmeer.
English: In cats that show more severe signs, appropriate antibiotic treatment may be indicated.
Maltese: F' qtates li juru sinjali aktar gravi, jista' jkun indikat trattament adattat b'antibijotiku.
English: Lyohpilisate:
Maltese: Preżentazzjoni:
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 1 dose
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI 1 Doża
English: MARKETING AUTHORISATION NUMBER(S) EU/2/02/034/001-002
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/02/034/001-002
English: MANUFACTURER'S BATCH NUMBER Lot/Batch {number}
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott {numru}
English: Manufacturers of the biological active substance
Maltese: TAS-SUSTANZA BIOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: 106.3-108.3 colony forming units (CFU) of live Bordetella bronchiseptica strain B-C2 Solvent:
Maltese: Lajofiliżejt: ≥ 106.3 u ≤ 108.3 ta' partijiet li jiffurmaw kolonji (PJK) tal-batterja ħajja Bordatella bronchiseptica strejn B-C2,
English: Excipients: For a full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' l-ingredjenti (mhux attivi), ara sezzjoni 6.1.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (0.2 ml) of reconstituted suspension contains: Lyophilisate:
Maltese: Kull doża (0.2ml) tas-suspensjoni rikostitwita fiha: Lajofiliżejt:
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 their territory if it is established that:
Maltese: Skond l-Artikolu 71 tad-Direttiva 2001/82/KE, tal-Parlament Ewropej u tal-Kunsill kif amendat, stat membru jistgħa, bi qbil mal-leġizlazzjoni nazzjonali, jipprojbixxu l-manifattura, l-importazzjoni, ilbejgħ, il-forniment u/jew l-użu tal-prodott immunoloġiku mediċinali veterinarju fit-territorju sħiħ tagħhom jew parti minnu jekk jiġi stabbilit illi:
English: Plastic box containing 5 vials of 1 dose of lyophilisate and 5 vials of solvent.
Maltese: Kaxxa tal-plastik li fiha 5 fjali ta' 1 doża ta' lajofiliżejt , u 5 fjali ta' solvent.
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 dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: INDICATION(S)
Maltese: INDIKAZZJONI (JIET)
English: PHARMACEUTICAL FORM Lyophilisate and solvent for suspension.
Maltese: 3. GĦAMLA FARMAĊEWTIKA Lajofiliżejt u solvent għal suspensjoni.
English: IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Immunologicals for felidae - cat - live bacterial vaccines.
Maltese: Immunoloġiċi għall-felidae - qtates - vaċċin batteriku ħaj.
English: One 3 ml unit-dose vial (glass Type I) of lyophilisate sealed with a halogenobutyl rubber stopper and an aluminium cap, supplied with a vial (glass Type I) of 0.5 ml sterile solvent sealed with a halogenobutyl rubber stopper.
Maltese: Fjal wieħed ta' 3ml, li jkun fih ammont ta' lajofiliżejt għal doża, (magħmul minn ħġieġ Tip I) ssiġillat b'tapp tal-gomma u kappa tal-aluminjum, flimkien ma fjal (ta' ħġieġ Tip I) b'0.5ml ta' solvent sterili ssiġillat b'tapp tal-gomma .
English: Lyophilisate:
Maltese: Lajofiliżejt:
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 0.5 ml
Maltese: PIŻ, VOLUM JEW NUMRU TA' DOŻI 0.5ml
English: ROUTE(S) OF ADMINISTRATION Nasal use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Għal użu fl-imnieħer.
English: The duration of immunity is up to 1 year.
Maltese: L-immunita ddum sa sena.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Bb for cats
Maltese: VETERINARJU Nobivac Bb għal qtates
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Bb lyophilisate and solvent for suspension for cats
Maltese: VETERINARJU Nobivac Bb lajofiliżejt u solvent għall-suspensjoni għall- qtates
English: Nasal use.
Maltese: Mhux applikabbli.
English: Carton box containing 5 vials of 1 dose of lyophilisate and 5 vials of solvent.
Maltese: Kaxxa tal-kartun li fiha 5 fjali ta' 1 doża ta' lajofiliżejt , u 5 fjali ta' solvent.
English: colony forming units (CFU) of live Bordetella bronchiseptica bacteria strain B-C2
Maltese: ta' partijiet li jiffurmaw kolonji (PJK) tal-batterja ħajja Bordatella bronchiseptica strejn B-C2,
English: No adverse reactions other than those mentioned in section 4.6 were observed after the administration of an overdose of the vaccine.
Maltese: L-ebda rejazzjoni mhux mixtieqa apparti dawk msemmija f'sezzjoni 4.6 ma ġew osservati wara amministrazzjoni ta' doża eċċessiva tal-vaċċin.
English: LABELLING
Maltese: MANIFATTURI
English: Onset of immunity: Onset of immunity was established in 8 week old cats as early as 72 hours after vaccination.
Maltese: Il-bidu tal-immunita ġie stabbilit fi qtates ta' tmien ġimgħat, sa minn 72 siegħa wara t-tilqima.
English: Solvent: Water for injection
Maltese: Solvent Ilma għal injezzjoni
English: Withdraw 0.2 ml of reconstituted vaccine into a 1 ml or 2 ml syringe, remove the needle and administer the whole contents of the syringe into one of the cat's nostrils.
Maltese: 2ml ta' vaċċin imħallat ġewwa siringa ta' millilitru jew żewġ millilitri, neħħi l-labbra u amministra l-kontenut kollu tas-siringa f'waħda mill-imnifsejn talqattus.
English: Store at 2 - 8C.
Maltese: oC - 8
English: INDICATION Live vaccine against feline upper respiratory tract disease caused by Bordetella bronchiseptica.
Maltese: Vaċċin ħaj kontra mard fil-parti ta' fuq tas-sistema respiratorja fil-qtates ikkawżat minn Bordetella bronchiseptica.