FrancophonIA/ELRC3.0 huggingface dataset:
English: On the basis of the scientific conclusions for denosumab (indicated for osteoporosis and for bone loss associated with hormone ablation in prostate cancer) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing denosumab (indicated for osteoporosis and for bone loss associated with hormone ablation in prostate cancer) is unchanged subject to the proposed changes to the product information.
Maltese: Abbażi tal-konklużjonijiet xjentifiċi għal denosumab (indikat għal osteoporożi u għat-telf ta' għadam assoċjat ma' asportazzjoni tal-ormoni fil-kanċer tal-prostata) is-CHMP huwa tal-fehma li l-bilanċ bejn il-benefiċċju u r-riskju ta' prodott(i) mediċinali li fih/fihom denosumab (indikat għal osteoporożi u għat-telf ta' għadam assoċjat ma' asportazzjoni tal-ormoni fil-kanċer tal-prostata) huwa favorevoli suġġett għall-bidliet proposti għall-informazzjoni tal-prodott.
English: Adverse reactions reported in patients with osteoporosis and breast or prostate cancer patients receiving hormone ablation
Maltese: Reazzjonijiet avversi rrappurtati f' pazjenti b'osteoporożi u f'pazjenti b'kanċer tassider jew tal-prostata li qed jirċievu asportazzjoni tal-ormoni
English: Bone is a living tissue and is renewed all the time.
Maltese: L-għadam huwa tessut ħaj li jinbidel kontinwament.
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Maltese: Studji fuq l-annimali ma jindikawx effetti ħżiena diretti jew indiretti rigward il-fertilità (ara sezzjoni 5.3).
English: Atypical femoral fractures have been reported in patients receiving denosumab (see section 4.8).
Maltese: F'pazjenti li kienu qed jirċievu denosumab kien irrappurtat ksur mhux tipiku tal-wirk (ara sezzjoni 4.8).
English: • Upper part of your thigh.
Maltese: • Il-parti ta' fuq tal-koxxa.
English: • don't receive routine dental care or have not had a dental check-up for a long time.
Maltese: • ma jirċivix kura dentali ta' rutina jew ma kellekx eżaminazzjoni dentali għal żmien twil.
English: Step 1: Prepare A Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included).
Maltese: Pass 1: Preparazjoni A Neħħi it-trej tas-siringa mimlija għal-lest mill-pakkett u iġbor l-affarjiet li għandek bżonn għall-injezzjoni tiegħek: imsielaħ bl-alkoħol, biċċiet tat-tajjar jew garża, stikk u kontenitur għar-rimi ta' oġġetti li jaqtgħu jew bil-ponta (mhux inklużi).
English: Effect on Bone Mineral Density (BMD)
Maltese: Effett fuq id-densità tal-minerali fl-għadam
English: Efficacy and safety of Prolia once every 6 months for 1 year were investigated in 242 men aged 31-84 years.
Maltese: L-effikaċja u s-sigurtà ta' Prolia darba kull 6 xhur għal sena kienu nvestigati f'242 raġel b'età minn 31 sa 84 sena.
English: Knockout mice (see section 4.6) lacking RANK or RANKL exhibited decreased body weight, reduced bone growth and lack of tooth eruption.
Maltese: Ġrieden knockout (ara sezzjoni 4.6) li m'għandhomx RANK jew RANKL urew tnaqqis fil-piż talġisem, tnaqqis fit-tkabbir tal-għadam u nuqqas ta' ħruġ ta' snien.
English: Lichenoid drug eruptions (e.g. lichen planus-like reactions), have been reported in patients in the postmarketing setting.
Maltese: Kienu rrappurtati eruzzjonijiet Lichenoid minħabba l-mediċina (eż. reazzjonijiet simili għal lichen planus) fil-pazjenti fl-ambjent ta' wara t-tqegħid fis-suq.
English: What is in this leaflet
Maltese: II u ta' fażi
English: In a prospectively planned exploratory analysis, significant increases in BMD were observed at the lumbar spine, total hip, femoral neck and the hip trochanter 1 month after the initial dose.
Maltese: F'analiżi esploratorja ppjanata b'mod prospettiv, xahar wara l-ewwel doża kienu osservati żidiet sinifikanti fil-BMD fl-ispina lombari, ġenbejn totali, għonq tal-wirk u fit-trochanter tal-ġenbejn.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit-risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Elderly (age ≥ 65) No dose adjustment is required in elderly patients.
Maltese: Anzjani (età ta' ≥ 65)
English: In preclinical studies conducted in knockout mice lacking RANK or RANKL, impairment of lymph node formation was observed in the foetus.
Maltese: Fi studji ta' qabel l-użu kliniku li saru fuq ġrieden knockout li ma kellhomx RANK jew RANKL, kien osservat indeboliment fil-formazzjoni tal-glandoli tal-limfa fil-fetu.
English: Discard date..............................
Maltese: Data tar-rimi..............................
English: 8 hours 8 hours
Maltese: 8 sigħat 8 sigħat
English: LILLY FRANCE 13 Rue Pages 92158 Suresnes Cedex FRANCE
Maltese: LILLY FRANCE 13 Rue Pages 92158 Suresnes Cedex FRANZA
English: 3991 RA Houten THE NETHERLANDS
Maltese: 3991 RA Houten
English: Linda-a-Pastora 2790-326 QUEIJAS PORTUGAL
Maltese: Linda-a-Pastora 2790-326 QUEIJAS ILPORTUGALL
English: Via A. Gramsci, 731/733 Sesto Fiorentino ITALY
Maltese: Gramsci, 731/733 Sesto Fiorentino L-ITALJA
English: Biotransformation: Several metabolites are formed, the predominant one being identified as T1 (Ndemethyl tilmicosin).
Maltese: Diversi metaboliti jiġu ffurmati, u dak predominanti ġie identifikat bħala T1 (Ndemethyl tilmicosin).
English: Phosphoric acid (for pH adjustment)
Maltese: Phosphoric acid (għal aġġustament tal-pH)
English: 1000 Brussel
Maltese: 1000 Brussel IL-BELĠJU
English: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/02/WC500070670.pdf a single subcutaneous injection with tilmicosin at a dose of 10 mg/kg body weight.
Maltese: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/02/WC500070670.pdf punteġġi tad-dispneja u fil-punteġġi tal-imġiba fit-tielet jum wara injezzjoni waħda taħt il-ġilda b'tilmicosin f'doża ta' 10 mg/kg tal-piż tal-ġisem.
English: In rare cases recumbency, incoordination and convulsions have been observed.
Maltese: F'każijiet rari, ġew osservati recumbency, nuqqas ta' koordinazzjoni u konvulżjonijiet.
English: Tilmicosin in vitro microbiological data of European isolates from respiratory disease in bovines were presented for several periods (2002-2004; 2004-2006 and 2009-2013).
Maltese: Kienet ippreżentata dejta mikrobijoloġika in vitro dwar tilmicosin, ta' iżolati Ewropej minn mard respiratorju fl-ifrat għal diversi perjodi (2002-2004; 2004-2006 u 2009-2013).
English: Eli Lilly & Company Ltd Elanco Animal Health Lilly House
Maltese: Ir-Renju Unit Eli Lilly & Company Ltd Elanco Animal Health Lilly House
English: Mannheimia, Pasteurella, Actinomyces (Corynebacterium), Fusobacterium, Dichelobacter, Staphylococcus, and Mycoplasma organisms of bovine and ovine origin.
Maltese: Mannheimia, Pasteurella, Actinomyces (Corynebacterium), Fusobacterium, Dichelobacter,
English: This antibacterial activity is predominantly against Gram-positive microorganism with activity against certain Gram-negative ones and Mycoplasma of a bovine and ovine origin.
Maltese: Din l-attività antibatterjali hi predominantement kontra mikroorganiżmi Gram-pożittivi b'attività kontra ċerti mikroorganiżmi Gram-negattivi u Mycoplasma ta' oriġini bovina u ovina.
English: PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic Group: antibacterials for systemic use, macrolides.
Maltese: Grupp farmako-terapewtiku: antibatterjali għal użu sistemiku, makrolidi.
English: Eli Lilly Nederland B.V./Elanco AnimalHealth Grootslag 1-5
Maltese: Il-Pajjiżi l-Baxxi Eli Lilly Nederland B.V./Elanco AnimalHealth Grootslag 1-5
English: 40 kg animals 28-50 kg animals
Maltese: Annimali ta' 40 kg Annimali ta' 28-50 kg
English: Tilmicosin is a macrolide antibiotic synthesized from tylosin which has an antibacterial spectrum similar to tylosin with enhanced activity against Pasteurella multocida and Mannheimia haemolytica.
Maltese: Tilmicosin huwa antibijotiku makrolidi sintetizzat minn tylosin li għandu firxa antibatterika simili għal tylosin b'attività mtejba kontra l-Pasteurella multocida u l-Mannheimia haemolytica.
English: Additional operator safety warnings:
Maltese: Twissijiet addizzjonali tas-sigurtà lill-operatur:
English: Treatment of acute ovine mastitis caused by Staphylococcus aureus and Mycoplasma agalactiae.
Maltese: Kura ta' mastite akuta ovina kkawżata minn Staphylococcus aureus u Mycoplasma agalactiae.
English: Tilmicosin is a mainly bactericidal semi-synthetic antibiotic of the macrolide group.
Maltese: Tilmicosin hu primarjament antibijotiku semisintetiku batteriċidjali tal-grupp tal-makrolidi.
English: Intravenous injection of 4.5 to 5.6 mg tilmicosin/kg body weight followed by intravenous injection of 1 ml epinephrine (1/1000) 2 to 6 times resulted in death of all 6 injected pigs.
Maltese: Injezzjoni ġol-vina ta' 4.5-5.6 mg ta' tilmicosin/kg ta' piż tal-ġisem segwita minn injezzjoni ġol-vina ta' 1 ml ta' epinephrine (1/1000) minn 2 sa 6 darbiet, irriżultat fil-mewt tas-6 qżieqeż kollha li ġew injettati.
English: Dose Rate
Maltese: DATA TA' SKADENZA
English: Regarding the treatment of acute ovine mastitis associated with Staphylococcus aureus and Mycoplasma agalactiae, the pathogens Staphylococcus aureus and Mycoplasma agalactiae appear to be sensitive for tilmicosin according to the measured MIC values (S. aureus MIC <0.25-1 µg/ml, M. agalactiae MIC=0.5 µg/ml).
Maltese: Rigward il-kura ta' mastite akuta fin-nagħaġ assoċjata mal-Staphylococcus aureus u l-Mycoplasma agalactiae, il-patoġeni Staphylococcus aureus u Mycoplasma agalactiae jidhru li huma sensittivi għal tilmicosin skont il-valuri tal-MIC imkejla (S. aureus MIC <0.25-1 µg/ml, M. agalactiae MIC=0.5 µg/ml).
English: Pregnancy:
Maltese: Eliminazzjoni:
English: On 24 April 2012, the Netherlands sent a referral notification under Article 34(1) of Directive 2001/82/EC, as amended, to the CVMP/European Medicines Agency for Micotil 300 mg/ml Injectie and its associated names.
Maltese: Fl-24 ta' April 2012, il-Pajjiżi l-Baxxi bagħtu notifika ta' riferiment skont l-Artikolu 34(1) tadDirettiva 2001/82/KE, kif emendata, lis-CVMP/l-Aġenzija Ewropea għall-Mediċini għal Micotil 300 mg/ml Injectie u ismijiet assoċjati.
English: Cross resistance between tilmicosin and other macrolides and lincomycin has been observed.
Maltese: Reżistenza inkroċjata bejn tilmicosin u makrolidi oħrajn u lincomycin ġiet osservata.
English: Subcutaneous injection
Maltese: INJECTIE
English: The cardiovascular system is the target of toxicity, and this toxicity may be due to calcium channel blockade.
Maltese: Is-sistema kardjovaskulari hi l-mira ta' tossiċità, u din it-tossiċità tista' tkun minħabba imblokk tal-kanal tal-calcium.
English: 6.1 List of excipients
Maltese: 6.1 Lista ta' ingredjenti Propylene glycol
English: Pharmacokinetic studies demonstrate that concentrations of tilmicosin in the lung can exceed 2 µg/ml for more than 3 days which would be therapeutic for M. haemolytica, Trueperella pyogenes (formerly known as Actinomyces pyogenes), Staphylococcus aureus and Mycoplasma ovipneumonia according to in vitro studies conducted in 1992.
Maltese: Studji farmakokinetiċi juru li l-konċentrazzjonijiet ta' tilmicosin fil-pulmun jistgħu jaqbżu 2 µg/ml għal aktar minn 3 ijiem li jkunu terapewtiċi għall-M. haemolytica, it-Trueperella pyogenes (li qabel kienet magħrufa bħala Actinomyces pyogenes), l-iStaphylococcus aureus u l-Mycoplasma ovipneumonia skont studji in vitro li saru fl-1992.
English: Bacteria spp MIC (µg/ml) range MIC50 (µg/ml)
Maltese: Batterji spp medda ta' MIC (µg/ml)
English: 1030 Vienna AUSTRIA
Maltese: 1030 Vienna L-AWSTRIJA
English: Beta adrenergic antagonists such as propanolol exacerbated the negative inotrophy of tilmicosin in dogs.
Maltese: Antagonisti adrenerġiċi beta bħal propanolol aggravaw l-inotrofija negattiva ta' tilmicosin fil-klieb.
English: Meat and offal: 70 days Milk: 36 days
Maltese: Laħam u ġewwieni tal-annimali: 70 jum Ħalib: 36 jum
English: 1030 Wien
Maltese: 1030 Wien L-AWSTRIJA
English: Method of administration:
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI
English: This led the CVMP in 2005 to limit the use of Micotil to sheep weighing more than 15 kg and to be administered by veterinary surgeons only (referral procedure under Article 35 of Directive 2001/82/EC, for Micotil 300 (EMEA/V/A/010)).
Maltese: Fl-2005 dan wassal lis-CVMP sabiex jillimita l-użu ta' Micotil għal nagħaġ li jiżnu aktar minn 15 kg u biex jingħata biss minn kirurgi veterinarji (proċedura ta' riferiment skont l-Artikolu 35 tad-Direttiva 2001/82/KE, għal Micotil 300 (EMEA/V/A/010)).
English: Meat and offal: 42 days Milk: 18 days
Maltese: 42 jum Ħalib: 18-il jum
English: The CVMP concluded that, due to limited availability of alternative veterinary medicinal products for this indication and in the absence of reports on suspected lack of efficacy, the indication “for treatment of ovine mastitis associated with Staphylococcus aureus and Mycoplasma agalactiae” should be maintained, but in a modified manner to better reflect the study results, to “treatment of acute ovine mastitis associated with Staphylococcus aureus and Mycoplasma agalactiae”.
Maltese: Is-CVMP ikkonkluda li, minħabba d-disponibbiltà limitata ta' prodotti mediċinali veterinarji alternattivi għal din l-indikazzjoni u fl-assenza ta' rapporti dwar in-nuqqas suspettat ta' effikaċja, l-indikazzjoni “għall-kura ta' mastite fin-nagħaġ assoċjata maliStaphylococcus aureus u l-Mycoplasma agalactiae” għandha tinżamm, iżda b'mod modifikat sabiex tirrifletti aħjar ir-riżultati tal-istudju, għal “kura ta' mastite akuta fin-nagħaġ assoċjata maliStaphylococcus aureus u l-Mycoplasma agalactiae”.
English: The available data demonstrated that tilmicosin is efficacious at the proposed dose of 10 mg tilmicosin/kg body weight against interdigital necrobacillosis in cattle and foot rot in sheep.
Maltese: Id-dejta disponibbli wriet li tilmicosin huwa effikaċi fid-doża proposta ta' 10 mg tilmicosin/kg tal-piż tal-ġisem kontra n-nekrobaċillosi interdiġitali fl-ifrat u t-tmermir tas-saqajn fin-nagħaġ.
English: The Clinical and Laboratory Standards Institute (CLSI) has set the interpretive criteria for tilmicosin against M. haemolyica of bovine origin and specifically for bovine respiratory disease, as ≤8µg/ml = susceptible, 16 µg/ml = intermediate and ≥ 32 µg/ml = resistant.
Maltese: Il-Clinical and Laboratory Standards Institute (CLSI) stabbilixxa l-kriterji interpretattivi għal tilmicosin kontra M. haemolyica ta' oriġini bovina u speċifikament għall-marda respiratorja tal-baqar,
English: Milk: 18 days
Maltese: Ħalib: 18-il jum
English: Treatment of foot rot in sheep caused by Dichelobacter nodosus and Fusobacterium necrophorum.
Maltese: Kura ta' taħsir tas-saqajn fin-nagħaġ ikkawżat minn Dichelobacter nodosus u Fusobacterium necrophorum.
English: 10 mg/kg body weight 10 mg/kg body weight
Maltese: 10 mg/kg ta' piż tal-ġisem 10 mg/kg ta' piż tal-ġisem
English: 6.5 Nature and composition of immediate packaging 25 ml, 50 ml, 100 ml or 250 ml amber glass vials (Type I or Type II) sealed with a rubber stopper and aluminium overseal.
Maltese: Kunjetti tal-ħġieġ ta' lewn safrani ta' 25 ml, 50 ml, 100 ml jew 250 ml (Tip I jew Tip II) issiġillati b'tapp tal-lastku u siġill li jgħattih tal-aluminju.
English: Sheep Treatment of respiratory tract infections caused by Mannheimia haemolytica and Pasteurella multocida.
Maltese: Kura ta' infezzjonijiet fl-apparat respiratorju kkaġunati minn Mannheimia haemolytica u Pasteurella multocida.
English: A dose of 30 mg/kg body weight resulted in increased respiratory rate.
Maltese: Doża ta' 30 mg/kg tal-piż tal-ġisem wasslet għal żieda fir-rata respiratorja.
English: The second clinical trial which studied efficacy of tilmicosin against reproductive diseases showed no inferiority towards the positive control (penicillin combined with an aminoglycoside) however no negative controls were included.
Maltese: It-tieni prova klinika li studjat l-effikaċja ta' tilmicosin kontra mard riproduttiv ma wriet l-ebda inferjorità għall-kontroll pożittiv (penicillin flimkien ma' aminoglycoside) madankollu ma kienu inklużi l-ebda kontrolli negattivi.
English: Use 10 mg tilmicosin per kg body weight (corresponding to 1 ml “product name (to be completed nationally)” per 30 kg body weight).
Maltese: Uża 10 mg ta' tilmicosin għal kull kg ta' piż tal-ġisem (li jikkorrispondu għal 1 ml ta' “product name (biex timtela mill-pajjiż partikolari)” għal kull 30 kg ta' piż tal-ġisem).
English: Cardiovascular toxicity may be due to calcium channel blockade.
Maltese: Tossiċità kardjovaskulari tista' tkun minħabba imblokk tal-kanal tal-calcium.
English: Dobutamine partially offset the negative inotropic effects induced by tilmicosin in dogs.
Maltese: Dobutamine itaffi ftit mill-effetti inotropiċi negattivi indotti minn tilmicosin fil-klieb.
English: Czech Republic EIi Lílly Regional Operations GmbH Elanco Animal Health Kölblgasse 8-10
Maltese: EIi Lílly Regional Operations GmbH Elanco Animal Health Kölblgasse 8-10
English: Furthermore, the text in the proposed indication “…and other microorganisms sensitive to tilmicosin” is not in accordance with recommendations in the CVMP reflection paper on macrolides, lincosamides and streptogramins (EMA/CVMP/SAGAM/741087/2009)1 and not in line with the CVMP guideline on the SPC for antimicrobials (EMEA/CVMP/SAGAM/383441/2005)2.
Maltese: Barra minn hekk, it-test flindikazzjoni proposta “…u mikroorganiżmi oħra sensittivi għal tilmicosin” mhuwiex skont ir rakkomandazzjonijiet fid-dokument ta' riflessjoni tas-CVMP dwar il-makrolidi, il-linkosamidi u listreptogramini (EMA/CVMP/SAGAM/741087/2009)1 u mhux skont il-linja gwida tas-CVMP dwar lSPC għas-sustanzi antimikrobiċi (EMEA/CVMP/SAGAM/383441/2005)2.
English: The CLSI at the present time have no interpretive criteria for P. multocida of bovine origin, however they have interpretive criteria for P. multocida of swine origin, specifically swine respiratory disease, as ≤16 µg/ml = susceptible and ≥ 32 µg/ml = resistant.
Maltese: Is-CLSI bħalissa m'għandu l-ebda kriterji interpretattivi għal P. multocida ta' oriġini bovina, madankollu għandhom kriterji interpretattivi għal P. multocida ta' oriġini mill-qżieqeż, speċifikament mard respiratorju talqżieqeż, bħala ≤16 µg/ml = suxxettibbli u ≥ 32 µg/ml = reżistenti.
English: Operator Safety Warnings:
Maltese: Kodici ATC veterinarja:
English: • This product should only be administered by a veterinary surgeon.
Maltese: • Dan il-prodott għandu jingħata biss minn kirurgu veterinarju.
English: Absorption: Several studies have been conducted.
Maltese: Twettqu diversi studji.
English: Higher doses (150 mg/kg body weight) caused ataxia, lethargy and the inability to raise the head.
Maltese: Dożi ogħla (150 mg/kg ta' piż tal-ġisem) ikkawżaw atassija, letarġija u l-inabilità li l-annimal jerfa' rasu.
English: OTHER INFORMATION “product name (to be completed nationally)” is contained in 25 ml, 50 ml, 100 ml or 250 ml amber glass vials (Type I or Type II) sealed with a rubber stopper and aluminium overseal.
Maltese: IEĦOR “product name (biex timtela mill-pajjiż partikolari)” ikun ġo kunjetti tal-ħġieġ ta' lewn safrani ta' 25 ml, 50 ml, 100 ml jew 250 ml (Tip I jew Tip II) issiġillati b'tapp tal-lastku u siġill li jgħattih talaluminju.
English: In a clinical trial, treatment of Pasteurellosis was performed with a dose of 25 mg/kg body weight.
Maltese: Fi prova klinika, il-kura tal-Pasteurellosis twettqet b'doża ta' 25 mg/kg tal-piż tal-ġisem.
English: In dog studies, tilmicosin induced a negative inotropic effect with consequent tachycardia, and a reduction in systemic arterial blood pressure and arterial pulse pressure.
Maltese: Fi studji fuq il-kelb, tilmicosin induċa effett inotropiku negattiv b'takikardija konsegwenti, u tnaqqis fil-pressjoni sistemika tad-demm fl-arterji u pressjoni arterjali tal-polz.
English: See fold out label or package leaflet for details.
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu qegħdin fis-suq.
English: Propylene glycol
Maltese: TWISSIJIET SPEĊJALI
English: In pigs, intramuscular injection of 10 mg tilmicosin/kg body weight caused increased respiration, emesis and convulsions; 20 mg/kg body weight resulted in mortality in 3 of 4 pigs, and 30 mg/kg body weight caused the death of all 4 pigs tested.
Maltese: Fil-qżieqeż, injezzjoni ġol-muskoli ta' 10 mg ta' tilmicosin/kg ta' piż tal-ġisem ikkawżat żieda firrespirazzjoni, emesi u konvulżjonijiet; 20 mg/kg ta' piż tal-ġisem irriżultat fil-mortalità fi 3 minn 4 qżieqeż, u 30 mg/kg ta' piż tal-ġisem ikkawżat il-mewt tal-4 qżieqeż kollha li ġew ittestjati.
English: EXPIRY DATE
Maltese: DATA TA' SKADENZA JIS
English: Benefit-Risk assessment
Maltese: 3. Valutazzjoni benefiċċji/riskji
English: Bordetella bronchiseptica was not isolated in any clinical or preclinical study and no in vitro study has been performed with this bacteria.
Maltese: Il-Bordetella bronchiseptica ma kienet iżolata fl-ebda studju kliniku jew prekliniku u ma sar l-ebda studju in vitro b'dan il-batterju.
English: Apply a cold pack (not ice directly) to the injection site.
Maltese: Applika cold pack (mhux silġ direttament) fuq is-sit tal injezzjoni.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard carton
Maltese: Kartuna tal-cardboard
English: Micotil 300 Injectie and its associated names are veterinary medicinal products authorised for use in the target species cattle, sheep and rabbits for treatment of various infections caused by microorganisms susceptible to tilmicosin.
Maltese: Micotil 300 Injectie u ismijiet assoċjati huma prodotti mediċinali veterinarji awtorizzati għall-użu fl-ifrat, in-nagħaġ u l-fniek għall-kura ta' diversi infezzjonijiet ikkawżati minn mikroorganiżmi suxxettibbli għal tilmicosin.
English: Numerous field studies using naturally infected calves of various ages with pneumonia, conducted over 20 years ago, indicated that tilmicosin is not inferior towards other positive controls, being long acting antibiotics or combinations of two antibiotics.
Maltese: Diversi studji fuq il-post li użaw għoġġiela ta' diversi etajiet infettati b'mod naturali bil-pulmonite, li twettqu 'l fuq minn 20 sena ilu, indikaw li tilmicosin mhuwiex inferjuri għal kontrolli pożittivi oħra, sew jekk antibijotiċi li jaħdmu fit-tul jew kombinazzjonijiet ta' żewġ antibijotiċi.
English: The primary cardiac effects are increased heart rate (tachycardia) and decreased contractility (negative inotrophy).
Maltese: Leffetti kardijaċi primarji huma żieda fir-rata ta' taħbit tal-qalb (takikardija) u tnaqqis fil-kontrattilità (inotrofija negattiv).
English: The clinical trials did not demonstrate a bacteriological cure in sheep with acute mastitis caused by Staphyloccocus aureus and Mycoplasma agalactiae.
Maltese: Il-provi kliniċi ma wrewx kura batterjoloġika f'nagħaġ b'mastite akuta kkawżata minn Staphyloccocus aureus u Mycoplasma agalactiae.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holders in the Member States
Maltese: Lista ta' ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodott mediċinali veterinarju, speċi ta' annimal, mnejn jingħata, iddetenturi ta' l-awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri
English: Strength Pharmaceutical form
Maltese: TAL-PRODOTT MEDIĊINALI
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Maltese: Inkompatibilitajiet Fin-nuqqas ta' studji dwar il-kompatibilità, dan il-prodott mediċinali veterinarju ma jistax jintuża flimkien ma' prodotti mediċinali veterinarji oħra.