FrancophonIA/ELRC3.0 huggingface dataset:
English: Changes in Laboratory Test Results Uncommon: Increased blood lipids (fats) Rare:
Maltese: Bidliet fir-Riżultati ta' Testijiet tal-Laboratorju Mhux komuni: Żjieda ta' lipidi (xaħmijiet) fid-demm Rari:
English: - Clinical efficacy of moxifloxacin in the treatment of severe burn infections, fasciitis, major abscesses and diabetic foot infections with osteomyelitis has not been established.
Maltese: - L-effikaċja klinika ta' moxifloxacin fil-kura ta' infezzjonijiet severi ta' ħruq, faxxite, axxess maġġuri u infezzjonijiet ta' sieq dijabetika b'osteomjelite ma ġietx stabbilita.
English: Greece
Maltese: L-Olanda
English: The analysis of outlying QTc values demonstrated a consistent excess risk for moxifloxacin for the data from the CAP studies with ECG data.
Maltese: L-analiżijiet tal-valuri remoti ta' QTc urew riskju eċċessiv konsistenti għal moxifloxacin għad-dejta mill-istudji tal-CAP b'dejta tal-ECG.
English: Seizures incl.
Maltese: Ilma għall-injezzjonijiet
English: Adverse reactions observed in clinical trials with moxifloxacin 400 mg daily administered by the intravenous or oral route sorted by frequencies are listed below:
Maltese: Reazzjonijiet avversi osservati fi provi kliniċi b'moxifloxacin 400 mg kuljum mogħti fil-vini jew b'mod orali rranġati skond il-frekwenza huma mniżżla taħt:
English: The submitted ECG data and the analysis of outlying QTc values demonstrated a consistent excess risk of moxifloxacin in the studies with ECG data.
Maltese: Id-dejta tal-ECG sottomessa u l-analiżi ta' valuri remoti talQTc urew riskju eċċessiv konsistenti ta' moxifloxacin fl-istudji bid-dejta tal-ECG.
English: The Applicant discussed the efficacy and safety of sequential IV/oral moxifloxacin in the treatment of cSSSI and concluded that non-inferiority was demonstrated, and that the clinical studies and post-marketing safety data show no evidence that moxifloxacin-treated patients are at greater risk for morbidity, including cardiac and hepatic morbidity, than patients receiving comparator antibiotics.
Maltese: L-Applikant iddiskuta l-effikaċja u s-sigurtà ta' moxifloxacin sekwenzjali IV/orali fit-trattament ta' cSSSI u kkonkluda li n-nuqqas ta' inferjorità ntwera, u li l-istudji kliniċi u d-dejta dwar is-sigurtà ta' wara t-tqegħid fis-suq ma juru ebda evidenza li l-pazjenti li jiġu trattati b'moxifloxacin qegħdin f'riskju akbar għall-morbidità, inkluża l-morbidità kardijaka u epatika, milli pazjenti li qegħdin jirċievu antibijotiċi komparaturi.
English: Par- and Dysaesthesia Taste disorders (incl.
Maltese: Konfużjoni u disorjentazzjoni Disturbi fl-irqad (laktar insomnja)
English: Polyolefine bags with polypropylene port sealed in aluminium foil overwrap.
Maltese: Boroż tal-polyolefine b'tieqa tal-polypropylene issiġillata f'pakkett fuq barra tal-aluminium.
English: Anaphylaxis incl.
Maltese: Tfal u adoloxxenti
English: increase of a special liver enzyme in the blood (LDH)), increase of bilirubin in the blood, increase of a special liver enzyme in the blood (gammaglutamyl-transferase and/or alkaline phosphatase)
Maltese: Indeboliment fil-funzjoni tal-fwied (inkluż żjieda ta' enzima speċjali tal-fwied fiddemm (LDH)), żjieda tal-bilirubin fid-demm, żjieda ta' enzima speċjali tal-fwied fiddemm (gamma-glutamyl-transferase u/jew alkaline phosphatase)
English: Vomiting Gastrointestinal and abdominal pains
Maltese: Tqalligħ Rimettar Weġgħat gastrointestinali u addominali Dijarea
English: Like all medicines, Octegra can cause side effects, although not everybody gets them.
Maltese: Bħal kull mediċina oħra, Octegra jista' jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
English: Considering these results a metabolic interaction via cytochrome P450 enzymes is unlikely.
Maltese: Jekk jiġu kkunsidrati dawn ir-riżultati, interazzjoni metabolika permezz ta' l-enzimi taċ-ċitokromju P450 mhux probabbli.
English: The Applicant reiterated that the QTc changes observed did not translate into a higher risk to develop a clinical cardiac event.
Maltese: L-Applikant reġa' semma' li l-bidliet osservati fil-QTc ma jwasslux għal riskju ogħla li wieħed jiżviluppa avveniment kardijaku kliniku.
English: Germany:
Maltese: Il-Portugall:
English: Ventricular tachyarrhythmias Syncope (i.e., acute and short lasting loss of consciousness) Hypertension Hypotension
Maltese: Takiarritmiji ventrikulari Sinkope (i.e., telf akut ta' koxjenza għal tul ta' ħin qasir)
English: - If you have a history of tendon disease or disorder which was related to treatment with quinolone antibiotics (see sections Take special care ... and 4.
Maltese: - Jekk għandek passat ta' marda tat-tendon jew marda li kienet relata ma' kura b'antibijotiċi quinolone (ara sezzjonijiet Oqgħod attent ħafna ... u 4.
English: - The other ingredients are sodium chloride, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment) and water for injections
Maltese: - Is-sustanzi l-oħra huma sodium chloride, hydrochloric acid (għall-aġġustament tal-pH), sodium hydroxide (għall-aġġustament tal-pH) u ilma għall-injezzjonijiet Id-Dehra ta' Octegra u l-kontenuti tal-pakkett
English: No prolongation of the QT interval was seen when a dose of 30 mg/kg was infused over 60 minutes.
Maltese: Għall-infużjoni b'rata kostanti fuq medda ta' 60 minuta.
English: Moxifloxacin should be used with caution in patients with any condition pre-disposing to cardiac arrhythmias (e.g. acute myocardial ischaemia) because they may have an increased risk of developing ventricular arrhythmias (incl.
Maltese: Moxifloxacin għandu jintuża b'kawtela f'pazjenti b'kull kundizzjoni li tippredisponihom għallarritmija kardijaka (eż. iskemija mijokardijaka akuta) għax dawn jista' jkollhom riskju akbar li jiżviluppaw arritmija ventrikulari (inkluż torsade de pointes) u arrest kardijaku.
English: NAME OF THE MEDICINAL PRODUCT Octegra and associated names (see Annex I) 400 mg/250 ml solution for infusion [See Annex I - To be completed nationally]
Maltese: Octegra u ismijiet assoċjati (ara Anness I) 400 mg/250 ml soluzzjoni għall-infużjoni [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Further information) of Octegra.
Maltese: Aktar tagħrif) ta' Octegra.
English: - If you suffer from myasthenia gravis using Octegra may worsen the symptoms of your disease.
Maltese: - Jekk issofri minn myasthenia gravis l-użu ta' Octegra jista' jaggrava s-sintomi tal-marda tiegħek.
English: The data indicates that moxifloxacin carries a risk of severe hepatotoxicity at least 2-fold greater than comparators and the CHMP considers that the consistency of these risk estimates is a strong signal of an increased risk of hepatotoxicity, supporting non-first line use in the proposed indications.
Maltese: Id-dejta tindika li moxifloxacin għandu riskju ta' epatotossiċità severa mill-inqas darbtejn akbar mill-komparaturi u sCHMP jikkunsidra li l-konsistenza ta' dawn l-istimi tar-riskju hija sinjal qawwi ta' riskju miżjud ta' epatotossiċità, li jappoġġja l-użu mhux tal-ewwel linja fl-indikazzjonijiet proposti.
English: - the efficacy of IV (followed by PO) moxifloxacin in the treatment of CAP and cSSTI is established, however the safety profile of intravenous moxifloxacin when used to treat CAP or cSSTI raises some concerns, particularly with regard to hepatotoxicity and cardiac conduction effects,
Maltese: - l-effikaċja ta' moxifloxacin IV (segwit minn PO) fit-trattament tal-CAP u tal-cSSTI hija stabbilita, iżda l-profil tas-sigurtà ta' moxifloxacin ta' ġol-vina meta jintuża għat-trattament talCAP jew tal-cSSTI iqajjem ftit tħassib, b'mod partikolari fir-rigward tal-epatotossiċità u ta' effetti ta' trasmissjoni kardijaka,
English: increase in special kidney laboratory test results like urea and creatinine), kidney failure
Maltese: Indeboliment tal-kliewi (inkluż żjieda f'riżultati speċjali tal-laboratorju tal-kliewi bħal ureja u krejatinina), insuffiċjenza tal-kliewi
English: Do not use Octegra after the expiry date which is stated on the label on the bottle bag and carton.
Maltese: Tużax Octegra wara d-data ta' skadenza li tidher fuq it-tikketta fuq il-flixkun borża u l-kartuna.
English: The Applicant then discussed the cumulative review of spontaneous ADR reports on “QT/QTc prolongation” and “Torsade de Pointes” for IV only or IV/PO sequential treatment.
Maltese: “prolongazzjoni QT/QTc” u “Torsade de Pointes” għal IV biss jew trattament IV/PO sekwenzjali.
English: A precautionary measure would be to more frequently monitor the INR.
Maltese: Miżura ta' prekawzjoni tkun li jsir monitoraġġ aktar frekwenti ta' l-INR.
English: - If you suffer from epilepsy or a condition which makes you likely to have convulsions, tell your doctor before taking Octegra.
Maltese: - Jekk issofri minn epilessija jew minn kundizzjoni li tagħmlek probabbli li jkollok konvulżjonijiet, għid lit-tabib tiegħek qabel tieħu Octegra.
English: Hyperaesthesia
Maltese: Iperestesija
English: Ventricular tachyarrhythmias, hypotension, oedema, antibiotic associated colitis (incl.
Maltese: Tħossok maqtugħ minnek innifsek (telf ta' identità), ġenn (potenzjalment iwwassal li tagħmel ħsara lilek innifsek)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 bottle or 1 bag of 250 ml contains 400 mg moxifloxacin (as hydrochloride).
Maltese: U KWANTITATTIVA Fixkun jew borża ta' 250 ml fiha 400 mg ta' moxifloxacin (bħala hydrochloride).
English: Moxifloxacin has been shown to prolong the QTc interval on the electrocardiogram in some patients.
Maltese: Moxifloxacin intwera li f'xi pazjenti jtawwal l-interval QTc fuq l-elettrokardjogramma.
English: A large number of cases showing an increase in oral anticoagulant activity have been reported in patients receiving antibacterial agents, especially fluoroquinolones, macrolides, tetracyclines, cotrimoxazole and some cephalosporins.
Maltese: F'pazjenti li rċevew sustanzi kontra l-batterja, speċjalment fluoroquinolones, macrolides, tetracyclines, cotrimoxazole u ċertu cephalosporins, kienu rrapportati numru kbir ta' każijiet li wrew żjieda fl-attività ta' sustanzi orali kontra l-koagulazzjoni.
English: Octegra and associated names (see Annex I) 400mg/250ml solution for infusion
Maltese: Octegra u ismijiet assoċjati (ara Anness I) 400mg/250ml soluzzjoni ħall-infużjoni [Ara Anness I - Biex timtela mill-pajjiż partikolari.]
English: 400 mg Solution for infusion
Maltese: 400 mg Soluzzjoni għall-infużjoni
English: Patients were more likely to have a notable increase in QTc on intravenous moxifloxacin than on oral moxifloxacin.
Maltese: III issuġġerixxu riżultati simili għal moxifloxacin u għall-komparaturi.
English: - The efficacy of Octegra in the treatment of severe burns, infections of deep tissue, major purulent ulcers (abscesses) and diabetic foot infections with osteomyelitis (infections of the bone marrow) has not been established.
Maltese: - L-effikaċja ta' Octegra fil-kura ta' ħruq sever, infezzjonijiet fit-tessut fond, ulċeri maġġuri bilmaterja (axxessi) u infezzjonijiet ta' sieq dijabetika b'osteomjelite (infezzjonijiet tal-mudullun tal-għadam) ma ġietx stabbilita.
English: An early evaluation of the effects of moxifloxacin on QTc showed a correlation between plasma concentration and QTc in healthy subjects and increases in QTc were significantly higher in healthy elderly subjects post-moxifloxacin versus placebo.
Maltese: Filwaqt li d-dejta tal-effikaċja hija suffiċjenti biex tappoġġa indikazzjoni għall-użu fil-CAP hija tissuġġerixxi li moxifloxacin jista' ma jkunx tajjeb daqs xi reġimi alternattivi.
English: Efficacy in the treatment of CAP
Maltese: Effikaċja fit-trattament tal-CAP
English: - There is limited experience on use of sequential intravenous/oral Octegra for the treatment of infection of the lungs (pneumonia) acquired outside the hospital.
Maltese: - Hemm esperjenza limitata dwar l-użu ta' Octegra b'mod sekwenzjali fil-vini/orali għall-kura ta' infezzjoni tal-pulmun (pnewmonja) miksuba minn barra l-isptar.
English: Infusion site Common:
Maltese: Fwied Komuni:
English: For reasons of drug safety, moxifloxacin is therefore contraindicated in patients with: - Congenital or documented acquired QT prolongation - Electrolyte disturbances, particularly in uncorrected hypokalaemia - Clinically relevant bradycardia - Clinically relevant heart failure with reduced left-ventricular ejection fraction - Previous history of symptomatic arrhythmias
Maltese: Kemm f'investigazzjonijiet prekliniċi kif ukoll fil-bnedmin, wara esponiment għal moxifloxacin, kienu osservati tibdiliet fl-elettrofiżjoloġija kardijaka fil-forma ta' titwil ta' QT. Għalhekk, għarraġunijiet ta' sigurtà tal-mediċina, moxifloxacin huwa kontra-indikat f'pazjenti b': - Titwil ta' QT miksub b'mod konġenitali jew dokumentat - Disturbi fl-elektroliti, partikolarment f'każ ta' ipokalimja mhux ikkoreġuta - Bradikardija ta' rilevanza klinika - Insuffiċjenza tal-qalb ta' rilevanza klinika bi frazzjoni ta' tneħħija ventrikolari tax-xellug imnaqqsa - Passat ta' arritmija sintomatika
English: Infections caused by resistant bacteria or fungi e.g. oral and vaginal infections caused by Candida
Maltese: Infezzjonijiet ikkawżati minn batterja jew fungi reżistenti eż. infezzjonijiet orali u vaġinali kkawżati minn Kandida
English: Eye Uncommon: Visual disturbances incl.
Maltese: Għajn Mhux komuni: Disturbi fil-vista inkluż vista doppja jew imċajpra
English: Recovery of the dose (unchanged drug and metabolites) totalled to approximately 98% after intravenous administration of the drug.
Maltese: Irkupru tad-doża (mediċina mhux mibdula u metaboliti) ammontaw għal madwar 98% wara għoti fil-vini tal-mediċina.
English: The following information is intended for medical or healthcare professionals only:
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-Suq u l-Manifattur:
English: Regarding the risk of hepatic ADRs associated with IV/PO moxifloxacin, the greater background morbidity/clinical monitoring may partly explain the increased rates but it remains plausible that it is linked to the greater bioavailability of the IV formulation.
Maltese: Ko-morbiditajiet potenzjali ma jbiddlux il-fatt li l-għoti IV kellu riskju eċċessiv fuq il-komparaturi, inkluż l-istudju fl-anzjani.
English: “Complicated skin and skin structure infections only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection (see section
Maltese: “Infezzjonijiet ikkumplikati tal-ġilda u tal-istruttura tal-ġilda biss meta l-użu ta' aġenti antibatterjali, li normalment huma rakkomandati għat-trattament inizjali ta' din l-infezzjoni, jiġi kkunsidrat bħala mhux xieraq (ara s-sezzjoni 4.4)”
English: In several cases, the lower 95% CI around the treatment differences in individual studies were borderline with instances of notable numerical inferiority for moxifloxacin versus comparators.
Maltese: F'bosta każijiet, il-CI 95% l-aktar baxx madwar id-differenzi tat-trattament fi studji individwali kien joqrob ma' mumenti ta' inferjorità numerika notevoli għal moxifloxacin meta mqabbel mal-komparaturi.
English: However, the CHMP maintained its position, stating that the clinical and microbiological responses point to a conclusion that moxifloxacin IV/PO is not among the optimal treatments for cSSSI.
Maltese: Is-CHMP ħa nota tar-risposta tal-Applikant iżda kkunsidra li d-dejta indikat li probabbilment, moxifloxacin mhuwiex tajjeb daqs it-terapija komparattiva.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Influenza H7N1
Maltese: VETERINARJU Nobilis Influenza H7N1
English: II.E.2 Identification and assay of active ingredients 4.
Maltese: II.E.2 Identifikazzjoni u stima tas-sustanza attiva
English: A dose of 1 ml is advised.
Maltese: Do\a ta' 1mL hija rakkomandata.
English: Inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/CK/Italy/473/99), inducing an HI titre of ≥6.0 log2 as tested according to the potency test.
Maltese: Antiġen sħiħ inattivat tal-virus tal-influwenza avjarja, subtip H7N1 (strejn, A/CK/Italy/473/99), li jinduċi titru ta' HI ta' ≥6.0log2, kif ittestjat għat-test ta' potenza.
English: II.F.1 Stability of the bulk antigen 5.
Maltese: II.F.1 Stabillita tal-bulk antiġen
English: PACKAGE SIZE 250 ml
Maltese: DAQS TAL-PAKKETT 250ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Influenza H7N1 emulsion for injection
Maltese: VETERINARJU Nobilis Influenza H7N1 emulsjoni għal injezzjoni
English: Store refrigerated (2°C to 8°C).
Maltese: Aħżen fil-friġġ (2°C - 8°C)
English: 6.5 Nature and composition of immediate packaging 250 ml or 500 ml bottles of glass, hydrolytical class type II or of polyethylene terephthalate (PET).
Maltese: Fliexken tal-250 jew 500 ml, ta' ħġieġ, ta' klassi idrolitika tip II, jew tal-poli-etilin tereftalejt (PET).
English: On dose of 0.5 ml contains:
Maltese: Doża ta' 0.5ml fiha:
English: MARKETING AUTHORISATION NUMBER EU/2/07/073/001-004
Maltese: NUMRU TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/07/073/001-004
English: Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt ta' lAġenzija Ewropea għall-Mediċini (EMEA) http://www.emea.europa.eu
English: Sorbitane mono-oleate
Maltese: MILL-HRUĠ TALLOTT
English: From 8 to 14 days old: 0.25 ml subcutaneously
Maltese: Flieles li għandhom minn 8 -14 il-ġurnata: 0.25ml taħt il-ġilda
English: A transient diffuse swelling may occur at the vaccination site in 50% of the animals, which persists for about 14 days.
Maltese: Nefħa mifruxa ta' natura temporanja tista' sseħħ fil-post tat-tilqima f'50% tal-annimali, li tippersisti għal madwar 14 ilġurnata.
English: The vaccine stimulates active immunity against Avian Influenza virus type A, subtype H7N1.
Maltese: Il-vaċċin jistimula immunita attiva kontra l-virus tal-Influwenza Avjarja tip A, subtip H7N1.
English: If the circulating avian influenza field virus has a different H and/or N component to the H7N1 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic test to detect haemagglutinin and/or neuraminidase antibodies.
Maltese: Jekk il-virus tal-influwenza avjarja li qed jiċċirkula fil-beraħ għandu l-komponent Hu/jew N tiegħu differenti mill-H7N1, inkluż fil-vaċċin, ikun possibli li tagħraf tagħżel bejn tjur imlaqqma u dawk infettati billi tuża test dijagnostiku li jagħraf antikorpi Nuraminidejs.
English: Do not freeze.
Maltese: ASPETTI TA' SIGURTA
English: Ducks
Maltese: Biss
English: An up-to-date certificate of suitability should be provided for Rousselot Acid hide gelatin (European origin)
Maltese: Għandu jiġi provdut ċertifikat aġġornat li juri li l-ġilda Rousselot Acid (Oriġini Ewropeja) hija tajba.
English: A clear justification should be given in support of the proposed pass level of an HI serum titre of 6.0 log2.
Maltese: Ġustifikazzjoni ċara għandha tingħata li tissaportja il-livell aċċettabli propost ta' HI tajter tasserum ta' 6.0log2.
English: Polysorbate 80
Maltese: Paraffina likwida ħafifa Polisorbejt 80
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: Isem u indirizz tal-manufatturi tas-sustanza(i) bioloġika(ċi) attiva(i)
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
Maltese: Skond l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, l-Istati Membri jipprojbixxu jew jistgħu jipprojbixxu l-importazzjoni, il-bejgħ, il-forniment u/jew lużu tal-prodott mediċinali veterinarju fit-territorju sħiħ tagħhom jew parti minnu jekk jiġi stabbilit illi:
English: INDICATION(S) Active immunisation against avian influenza type A, subtype H7N1.
Maltese: INDIKAZZJONI(JIET) Għal immunizzazzjoni attiva fil-flieles kontra l-Influwenza avjarja tip A, subtip H7N1.
English: The following substances contained in the final product are included in Annex II of Council Regulation (EEC) No 2377/90:
Maltese: II tar-Regolament talKunsill (KE) Nru 2377/90:
English: -In chickens, reduction of clinical signs, mortality, excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination.
Maltese: Fil-flieles, tnaqqis ta' sinjali kliniċi, mortalita u tneħħija tal-virus wara tlaqqiegħ mal-vaċċin ġew murija fi żmien ġimgħatejn wara t-tilqima waħda
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Wim de Körverstraat 35 NL - 5831 AN Boxmeer The Netherlands
English: Batch potency test:
Maltese: Mhux applikabbli.
English: II.C.2 Not listed in a Pharmacopoeia
Maltese: II.C.2 Mhux fil-lista tal-Farmakopeja
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2°C to +8°C).
Maltese: Aħżen u ttrasporta ġo friġġ (2°C - 8°C).
English: For active immunisation of chickens and ducks against avian influenza type A, subtype H7N1.
Maltese: Għal immunizzazzjoni attiva fil-flieles u l-papri kontra l-Influwenza avjarja tip A, subtip H7N1.
English: DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION Chickens
Maltese: DOŻA GĦAL KULL SPEĊI, MODI U METODU TA' AMMINISTRAZZJONI
English: The applicant is required to submit 3-montly Periodic Update Safety reports for the first 2 years following the initial use in the field and is additionally required to present a protocol that would ensure adequate recording and reporting of field data in relation to suspected adverse reactions including suspected lack of efficacy.
Maltese: Huwa wkoll rikjest protokoll li jassigura rekordjar u rappurtaġġ ta' tagħrif miġbur fil-beraħ, f'relazzjoni ma' effetti mhux mixtieqa suspettati, inkluż nuqqas t'effikaċja.
English: DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TALAWTORIZZAZZJONI
English: 5831 AN Boxmeer The Netherlands
Maltese: NL - 5831 AN Boxmeer.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Maltese: .6 Prekawzjonijiet speċjali għar-rimi tal-prodotti mediċinali veterinarji mhux użata jew materjal ieħor għar-rimi li huwa derivat minn dawn il-prodotti
English: or S.C. injection Read the package leaflet before use.
Maltese: L-effikaċja kienet evalwata abbażi ta'riżultati preliminari fil-flieles u papri .
English: a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and 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: a) l-għotja tal-prodott mediċinali veterinarju lill-annimali tinterferixxi ma' limplimentazzjoni ta' programmi nazzjonali għad-djanjosi, il-kontroll u l-eradikazzjoni tal-mard ta' l-annimali, jew tikkawża diffikultajiet fiċ-ċertifikazzjoni ta' l-assenza tal kontaminazzjoni f' annimali ħajjin jew fl-ikel jew prodotti oħrajn akkwistati minn annimali ttrattati;
English: Any person intending to import, sell, supply and/or use Nobilis Influenza H7N1 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 Nobilis Influenza H7N1 għandha tikkonsulta ma' lAwtorità Kompetenti ta' l-Istat Membru dwar il-programmi ta' tilqim kurrenti qabel timporta, tbiegħ, tipprovdi u/jew tuża.
English: Emulsion of injection
Maltese: emulsjoni għal injezzjoni
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
Maltese: TAS-SUSTANZA BIOLOĠIKA ATTIVA U SID LAWTORIZZAZZJONI TAL-MANIFATTURA RESPONSABBLI
English: {250ml/500ml}
Maltese: Flixkun ta' 250ml / 500ml