FrancophonIA/ELRC3.0 huggingface dataset:
English: What is the risk associated with Baraclude?
Maltese: X'inhu r-riskju assoċjat ma' Baraclude?
English: Two of the studies were carried out in 1,363 patients who had not been treated with nucleoside analogues before.
Maltese: Tnejn minn dawn l-istudji twettqu fuq 1,363 pazjent li ma kinux ġew ikkurati b'analogi nukleosidi qabel.
English: Baraclude was also shown to be effective in the children's study: 24% of children in the Baraclude group achieved the primary goal of having a viral DNA level of less than 50 IU/ml plus production of antibody to e-antigen and no e-antigen in their blood compared with 2% of children in the placebo group.
Maltese: IU/ml barra minn produzzjoni ta' antikorpi għal antiġen-e u ebda antiġen-e f'demmhom meta mqabbel mat-2% tat-tfal fil-grupp tal-plaċebo.
English: At the end of the study, 55% of the patients treated with Baraclude had both a normal ALT level and undetectable viral DNA in their blood, while 4% of those treated with lamivudine showed the same results.
Maltese: Fl-aħħar tal-istudju, 55% tal-pazjenti kkurati b'Baraclude kellhom kemm livell normali ta' ALT u DNA virali li ma jistgħu jiġu osservati f'demmhom, filwaqt li 4% ta' dawk ikkurati b'lamivudina wrew l-istess riżultati.
English: How has Baraclude been studied?
Maltese: Kif ġie studjat Baraclude?
English: Baraclude was compared with lamivudine in three main studies in adults with chronic hepatitis B who had compensated liver disease.
Maltese: Baraclude tqabbel ma‘ lamivudina fi tliet studji ewlenin f'adulti li jbatu mill-epatite B kronika li kellhom mard fil-fwied ikkumpensat.
English: It can also be considered for children aged from 2 to 18 years but only in those with compensated liver disease.
Maltese: Jista' wkoll jiġi kkunsidrat għal tfal ta' età minn 2 sa 18-il sena iżda biss f'dawk li għandhom mard talfwied ikkumpensat.
English: Entecavir stops the virus making DNA, and prevents it from multiplying and spreading.
Maltese: Entecavir ma jħallix lill-virus jipproduċi DNA u ma jħallihx jimmultiplika ruħu u jinfirex.
English: For the full list of side effects and restrictions with Baraclude, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet kollha b'Baraclude, ara l-fuljett ta' tagħrif.
English: What measures are being taken to ensure the safe and effective use of Baraclude?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Baraclude?
English: Entecavir interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of viral DNA.
Maltese: Entecavir jinterferixxi mal-azzjoni ta' enzima virali msejħa DNA polimerażi, li għandha x'taqsam malformazzjoni ta' DNA virali.
English: • Use of antibiotics
Maltese: • L-użu ta' antibijotiċi
English: • Use of povidone iodine or equivalent
Maltese: • L-użu ta' povidone iodine jew ekwivalenti
English: • Sterile techniques, including periocular and ocular disinfection, to minimise risk of infection
Maltese: • Proċeduri tekniċi sterili, inkluż kif tidiżinfetta d-dawra ta' l-għajnejn u l-għajnejn, sabiex ikun minimizzat ir-riskju ta' infezzjoni
English: • Key signs and symptoms of IVT injection related adverse events
Maltese: • Sinjali u sintomi kruċjali ta' effetti avversi relatati ma' l-injezzjoni IVT
English: • Key signs and symptoms of serious adverse events
Maltese: • Sinjali u sintomi kruċjali ta' effetti avversi serji
English: The Marketing Authorisation Holder (MAH) shall ensure that updated physician information packs are provided to all ophthalmology clinics where Lucentis is expected to be used.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) sejjer jaċċerta, li pakketti ta' tagħrif aġġornati għat-tobba qed jingħataw lill-kliniċi oftalmoloġiċi kollha fejn Lucentis huwa mistenni li jintuża.
English: • Intravitreal injection procedure pictogram
Maltese: • Proċeduri tekniċi għall-injezzjoni fil-vitriju
English: The patient information pack should be provided in the form of both patient information booklets and audio-CD that contain following key elements:
Maltese: Il-pakkett ta' tagħrif tal-pazjent għandu jkun provdut kemm bħala kotba żgħar ta' tagħrif għallpazjent kif ukoll CD bl-awdjo li jkun fih dawn l-elementi kruċjali:
English: • Management of IVT injection related adverse events
Maltese: • Maniġġjar ta' effetti avversi relatati ma' l-injezzjoni IVT
English: • Intravitreal injection procedure video
Maltese: • Filmat tal-proċedura kif tingħata injezzjoni ġol-vitriju
English: • What are the steps following treatment with Lucentis
Maltese: • X'inhuma l-passi ta' wara l-kura b'Lucentis
English: 10 mg/160 mg Film-coated tablet
Maltese: Mnejn jingħata Il-pakkett
English: PhotoBarr porfimer sodium
Maltese: PhotoBarr porfimer sodiku
English: The full EPAR for PhotoBarr can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It contains the active substance porfimer sodium.
Maltese: Fih is-sustanza attiva porfimer sodiku.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for PhotoBarr can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni dwar PhotoBarr huwa disponibbli fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The most common side effects with PhotoBarr (seen in more than 1 patient in 10) are dehydration, oesophageal stenosis (narrowing of the oesophagus), vomiting, dysphagia (difficulty swallowing), constipation, nausea (feeling sick), photosensitivity reactions (sunburn-like reactions) and pyrexia (fever).
Maltese: L-iżjed effetti sekondarji komuni rraportati bl-użu ta' PhotoBarr (li dehru f'iktar minn pazjent 1 minn kull 10) huma deidradazzjoni, stenożi (tidjiq) fl-esofagu, remattar, disfaġija (diffikultà fil-bligħ tal-ikel), stitikezza, nawżja (mejt), reazzjonijiet fotosensittivi (reazzjonijiet bħall-ħruq) u piressija (deni).
English: What is PhotoBarr?
Maltese: X'inhu PhotoBarr?
English: Because the number of patients with Barrett's oesophagus is low, the disease is considered ‘rare', and PhotoBarr was designated an ‘orphan medicine' (a medicine used in rare diseases) on 6 March 2002.
Maltese: Minħabba li l-għadd ta' pazjenti li jbatu mill-marda ta' Barrett huwa baxx, din il-mard titqies ‘rari', u PhotoBarr ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fis-6 ta' Marzu 2002.
English: The European Commission granted a marketing authorisation valid throughout the European Union for PhotoBarr on 25 March 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Photobarr fl-25 ta' Marzu 2004.
English: This is a summary of the European public assessment report (EPAR) for PhotoBarr.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR).
English: PhotoBarr has been studied in one main study involving 208 patients who had Barrett's oesophagus with high-grade dysplasia.
Maltese: PhotoBarr ġie studjat fi studju wieħed ewlieni li involva 208 pazjenti li kellhom il-metaplażja talesofagu ta' Barrett b'diżplażija ta' grad għoli.
English: The active substance in PhotoBarr, porfimer sodium, is a photosensitising agent (a substance that changes when exposed to light).
Maltese: Is-sustanza attiva f'PhotoBarr, jiġifieri l-porfimer sodiku, hija aġent fotosensitizzanti (sustanza li tinbidel meta titpoġġa fid-dawl).
English: PhotoBarr must not be used in patients with porphyria (an inability to break down porphyrins), severe problems with the liver or kidneys, varices (swollen veins) in the oesophagus or stomach, large ulcers in the oesophagus, fistulae (abnormal passageways) between the oesophagus and either the trachea (windpipe) or the bronchi (airways in the lungs), or suspected damage to major blood vessels.
Maltese: PhotoBarr ma għandux jintuża minn pazjenti li jbatu mill-porfirija (inkapaċità fit-tkissir tal-porfirini), problemi severi fil-fwied jew filkliewi, variċi (vini minfuħin) fl-esofagu jew fl-istonku, ulċeri kbar fl-esofagu, fistula (ftuħ anormali) bejn l-esofagu u t-trakea (il-kanal tan-nifs) jew il-bronki (passaġġi tal-arja fil-pulmun), jew ħsara possibbli f'vini jew f'arterji ewlenin.
English: What is the risk associated with PhotoBarr?
Maltese: X'inhu r-riskju assoċjat ma' PhotoBarr?
English: After six months, 72% of the patients using PhotoBarr in combination with omeprazole had no high-grade dysplasia left, compared with 31% of those taking omeprazole alone.
Maltese: Wara sitt xhur, 72% tal-pazjenti li użaw PhotoBarr flimkien malomeprażole ma baqgħu juru l-ebda sintomu ta' diżplażija ta' grad għoli, apparagun mal-31% ta' dawk li ħadu l-omeprażole biss.
English: PhotoBarr is used in photodynamic therapy (treatment using light) for the ablation (destruction) of high-grade dysplasia (abnormal cells at high risk of turning into cancer) in patients with Barrett's oesophagus.
Maltese: PhotoBarr jintuża fit-terapija fotodinamika (trattament li juża d-dawl) għall-asportazzjoni (qerda) ta' diżplażija ta' grad għoli (ċelloli anormali b'riskju għoli li jsiru kanċer) f'pazjenti li jbatu mill-metaplażja tal-esofagu ta' Barrett.
English: Why has PhotoBarr been approved?
Maltese: Għaliex ġie approvat PhotoBarr ?
English: For a more complete list of the side effects reported with PhotoBarr, see the package leaflet.
Maltese: Għal lista iktar kompleta tal-effetti sekondarji rrappurtati bl-użu ta' PhotoBarr, ara lFuljett tat-Tagħrif.
English: How has PhotoBarr been studied?
Maltese: Kif ġie studjat PhotoBarr?
English: See the package leaflet for full details.
Maltese: Baqa' jsir segwitu tal-pazjenti sa mill-inqas sentejn wara.
English: Photodynamic therapy with PhotoBarr should only be carried out or supervised by a doctor who has experience in laser treatment using an endoscope (a thin tube used to look into the body) and who has been trained in photodynamic therapy.
Maltese: It-terapija fotodinamika b'PhotoBarr għandha tiġi mogħtija jew sorveljata minn tabib li jkun imġarrab fl-għoti tat-trattament bil-lajżer permezz tal-endoskopju (tubu rqiq li jintuża biex jintara l-ġewwien talġisem) u li jkun imħarreġ fit-terapija fotodinamika.
English: The CHMP decided that PhotoBarr's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' PhotoBarr huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Treatment with PhotoBarr is a two-step process: the medicine is given first before it is activated using a laser. PhotoBarr is given by slow, careful injection into a vein at a dose of 2 mg per kilogram body weight over three to five minutes.
Maltese: Meta tiddawwal bid-dawl tal-lejżer bi frekwenza speċifika, il-mediċina tiġi attivata u tirreaġixxi mal-ossiġenu li jkun hemm fiċ-ċelluli biex jinħoloq tip ta' ossiġenu reattiv u tossiku ħafna.
English: This kills the cells by reacting with and destroying their components, such as their proteins and DNA.
Maltese: Dan joqtol iċ-ċelluli billi jirreaġixxi mal-komponenti tagħhom bħall-proteini u d-DNA tagħhom.
English: The effects of photodynamic therapy with PhotoBarr, used in combination with omeprazole (an antacid medicine), were compared with those of omeprazole alone.
Maltese: Barra dan, PhotoBarr għandu jintuża biss jekk ikun hemm disponibbli fil-pront persunal imġarrab u materjal li jivvaluta u jittratta l-anafilassi (reazzjoni allerġika severa).
English: 20041 Agrate Brianza (MB) ITALY
Maltese: 20041 Agrate Brianza (MB) L-ITALJA
English: CEVA VETEM SpA via Colleoni 15
Maltese: SpA via Colleoni 15
English: Lilly Portugal - Produtos Farmacêuticos, Lda.
Maltese: Il-Portugall Lilly Portugal - Produtos Farmacêuticos, Lda.
English: In: Association of Exotic Mammal Veterinarians (AEMV) Sessions, Preceedings, 2006
Maltese: In: Association of Exotic Mammal Veterinarians (AEMV) Sessions, Preceedings, 2006 (Cathy A.
English: LILLY France 13 Rue Pages 92158 Suresnes Cedex
Maltese: LILLY Franza 13 Rue Pages 92158 Suresnes Cedex
English: Cathy A. Johnson-Delaney, DVM, Dipl ABVP (Avian).
Maltese: Johnson-Delaney, DVM, Dipl ABVP (Avian).
English: 34 Rue Jean Monnet Zi D'Etriche 49500 Serge FRANCE
Maltese: 34 Rue Jean Monnet Zi D'Etriche 49500 Serge FRANZA
English: During the previous referral procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/037)
Maltese: Matul il-proċedura ta' riferiment ta' qabel skont l-Artikolu 34 tad-Direttiva 2001/82/KE (EMEA/V/A/037)
English: 200 Route de Mayenne Zi des Touches 53000 Laval FRANCE
Maltese: Route de Mayenne Zi des Touches 53000 Laval FRANZA
English: ELI LILLY ITALIA SPA VIA GRAMSCI
Maltese: L-Italja ELI LILLY ITALIA SPA VIA GRAMSCI
English: Denmark Elanco Animal Health Eli Lilly Danmark A/S Nybrovej 110
Maltese: Elanco Animal Health Eli Lilly Danmark A/S Nybrovej 110
English: DK-2800 Kongens
Maltese: DK-2800 Kongens Lyngby
English: The pharmacokinetic parameters confirm the effective dose of tilmicosin.
Maltese: Il-parametri farmakokinetiċi jikkonfermaw id-doża effettiva ta' tilmicosin.
English: CVMP opinion following an Article 34 referral on Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names (2009)http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Pulmotil_Premix_34/WC500036654 .pdf
Maltese: Opinjoni tas-CVMP wara referenza skont l-Artikolu 34 dwar Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix u ismijiet assoċjati (2009)http://www.ema.europa.eu/docs/mt_MT/document_library/Referrals_document/Pulmotil_Premix_34/WC500036654 .pdf
English: Germany Lilly Deutschland GmbHAbt.
Maltese: Il-Ġermanja Lilly Deutschland GmbHAbt.
English: A-4600 Wels AUSTRIA
Maltese: A-4600
English: Belgium Eli Lilly Benelux N.V. Elanco Animal Health Rue de l'Etuve 52
Maltese: Il-Belġju Eli Lilly Benelux N.V. Elanco Animal Health Rue de l'Etuve 52
English: de la Industria 30 28108 Alcobendas Madrid
Maltese: ELANCO VALQUÍMICA, S.A. Avda. de la Industria 30 28108 Alcobendas Madrid
English: 12.5 mg/kg bodyweight/day
Maltese: 12.5 mg/kg piż talġisem/jum
English: 4.9 Amounts to be administered and administration route:
Maltese: .9 Doża rakkomandata u l-metodu ta' amministrazzjoni:
English: Netherlands Eli Lilly Nederland B.V. Elanco Animal Health Grootslag 1-5
Maltese: Eli Lilly Nederland B.V. Elanco Animal Health Grootslag 1-5
English: Netherlands Eli Lilly Nederland B.V.Elanco Animal Health
Maltese: Eli Lilly Nederland B.V.Elanco Animal Health
English: Prevention and treatment of respiratory disease
Maltese: Prevenzjoni u trattament tal-marda respiratorja
English: 3991 RA Houten
Maltese: 3991 RA Houten IL-PAJJIŻI L-BAXXI
English: CVMP Note for Guidance on additional quality requirements for products intended for incorporation into animal feedingstuffs (mediciated premixes)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004466.pdf
Maltese: Nota tas-CVMP għal Gwida dwar rekwiżiti addizzjonali tal-kwalità għal prodotti maħsuba għal inkorporazzjoni f'għalf tal-annimali (taħlitiet minn qabel medikati) (mhux disponibbli bil-Malti)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004466.pdf
English: Ireland Eli Lilly and Company Ltd Elanco Animal Health Lilly House
Maltese: L-Irlanda Eli Lilly and Company Ltd Elanco Animal Health Lilly House
English: Pulmotil G 20% AMV Tilmicosin (as phosphate)
Maltese: Pulmotil G 20% AMV Tilmicosin (bħala fosfat)
English: Concentrations are 10 - 13% higher than the expected nominal concentration of 200 mg/kg.
Maltese: Il-konċentrazzjonijiet huma 10 - 13% ogħla mill-konċentrazzjonijiet nominali mistennija ta' 200 mg/kg.
English: MICLOZAN 200 PRE-MIX Tilmicosin (as phosphate)
Maltese: MICLOZAN 200 PRE-MIX Tilmicosin (bħala fosfat)
English: Pulmotil 40 VET Pre-mix Tilmicosin (as phosphate)
Maltese: Pulmotil 40 VET Pre-mix Tilmicosin (bħala fosfat)
English: kg pre-mix/ton feed = Dose rate (mg/kg bodyweight) x bodyweight (kg) Daily feed intake (kg) x pre-mix strength (g/kg)
Maltese: kg taħlita minn qabel/tunnellata għalf = Rata tad-doża (mg/kg piż tal-ġisem) x piż tal-ġisem (kg) Teħid ta' għalf kuljum (kg) x saħħa tat-taħlita minn qabel (g/kg)
English: The pre-mixes for medicated feedingstuffs containing 40 g, 100 g or 200 g of tilmicosin per kg premix, are veterinary medicinal products which are indicated in pigs for the prevention and treatment of respiratory disease caused by Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida and other organisms sensitive to tilmicosin.
Maltese: It-taħlitiet minn qabel għall-għalf medikat li fih 40 g, 100 g jew 200 g tilmicosin għal kull kg taħlita minn qabel, huma prodotti mediċinali veterinarji li huma indikati fil-majjali għall-prevenzjoni u ttrattament ta' marda respiratorja kkaġunata minn Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida u organiżmi oħrajn sensittivi għal tilmicosin.
English: Regarding meal feeds, mean content was not in the range of 90-110% of the nominal content (180220 ppm), since concentration values were higher than the expected nominal concentration of 200 ppm ± 10% (values rate between 198.1 - 243.6 ppm).
Maltese: Rigward l-għalf magħġun, il-kontenut medju ma kienx fil-medda ta' 90-110% tal-kontenut nominali (180 - 220 ppm), peress li l-valuri ta' konċentrazzjoni kienu ogħla mill-konċentrazzjoni nominali mistennija ta' 200 ppm ± 10% (rata tal-valuri bejn 198.1 - 243.6 ppm).
English: Rua Cesário Verde, nº5- piso 4 Linda-a-Pastora 2790 - 326 QUEIJAS PORTUGAL
Maltese: Rua Cesário Verde, nº5- piso 4
English: Pulmotil 100 Granules Tilmicosin (as phosphate)
Maltese: Pulmotil 100 Granules Tilmicosin (bħala fosfat)
English: Administer in the feed at 12.5 mg/kg bodyweight/day of tilmicosin (equivalent to 200 ppm in the feed) for 7 days.
Maltese: Amministra fl-għalf bi 12.5 mg/kg piż tal-ġisem/jum ta' tilmicosin (ekwivalenti għal 200 ppm fl-għalf) għal 7 ijiem.
English: The relevant advice given in the product literature should be provided along with a discussion of whether this is in line with CVMP's Note for guidance (EMEA/CVMP/080/95).
Maltese: Il-parir relevanti mogħti fit-tagħrif dwar il-prodott għandu jiġi pprovdut flimkien ma' diskussjoni dwar jekk dan huwiex konformi man-Nota tas-CVMP għal gwida (EMEA/CVMP/080/95).
English: 5 kg tilmicosin 40 g premix /ton
Maltese: 5 kg tilmicosin 40 g taħlita minn qabel /tunnellata
English: On 8 April 2011, the European Commission initiated a referral under Article 35 of Directive 2001/82/EC, as amended, for all pre-mixes for medicated feedingstuff containing 40, 100 or 200 g tilmicosin per kg pre-mix and administered to rabbits.
Maltese: Fit-8 ta' April 2011, il-Kummissjoni Ewropea fetħet proċedura ta' riferiment skont l-Artikolu 35 tadDirettiva 2001/82/KE, kif emendata, għat-taħlitiet minn qabel kollha għal għalf medikat li fih 40, 100 jew 200 g tilmicosin għal kull kg taħlita minn qabel u amministrat lill-fniek.
English: Mean content in pelleted feeds was in the range of 90-110% of the nominal content therefore, the homogeneity of those medicated feeds is considered demonstrated.
Maltese: Il-kontenut medju f'għalf magħmul f'gerbubiet kien fil-medda ta' 90-110% tal-kontenut nominali u għaldaqstant, jitqies li ntweriet lomoġenità ta' dak l-għalf medikat.
English: Thus, one rabbit of 1.5 kg can consume in average 180 g of feed per day.
Maltese: B'hekk, fenek wieħed ta' 1.5 kg jista' jikkonsma medja ta' 180 g għalf kuljum.
English: Germany Lilly Deutschland GmbH Abt. Elanco Animal Health Werner-Reimers-Str. 2-4
Maltese: Elanco Animal Health Werner-Reimers-Str. 2-4
English: The use of tilmicosin in rabbits orally at 12.5 mg/kg bw/day for 7 days showed that from the second day of treatment, tilmicosin concentrations attained in lung tissue and pulmonary alveolar macrophages exceeded those in plasma by 7 and 400 fold, respectively, and high levels were maintained in lung tissues during the entire treatment duration.
Maltese: L-użu ta' tilmicosin fil-fniek b'mod orali bi 12.5 mg/kg bw/jum għal 7 ijiem wera li mit-tieni jum tattrattament, il-konċentrazzjonijiet ta' tilmicosin miksuba fit-tessut tal-pulmun u l-makrofaġi alveolari pulmonari qabżu dawk fil-plażma b'7 u 400 darba, rispettivament, u li l-livelli għoljin baqgħu fit-tessuti tal-pulmun sakemm dam it-trattament kollu.
English: Romania Eli Lilly Regional Operations GmbH
Maltese: Ir-Rumanija Eli Lilly Regional Operations GmbH
English: Pellet storage stability was evaluated by examining the difference in the level of tilmicosin assay over a 12 week period at 25 °C/60% relative humidity (RH) and 40 °C/70% RH.
Maltese: L-istabilità tal-ħżin tat-tiswir f'gerbubiet ġiet evalwata billi ġiet eżaminata d-differenza fil-livell tat-test ta' tilmicosin fuq perjodu ta' 12-il ġimgħa b'umdità relattiva (RH) ta' 25 °C/60% u RH ta' 40 °C/70%.
English: The results of a mixing uniformity study (with tilmicosin 100 g and 200 g pre-mixes) the homogeneity results obtained from ten analysed samples per batch, showed no samples out of the 85-115% range of the mean content.
Maltese: Ir-riżultati ta' studju ta' uniformità dwar it-taħlit (b'tilmicosin 100 g u 200 g taħlitiet minn qabel), irriżultati tal-omoġenità miksuba minn għaxar kampjuni analizzati għal kull porzjon, ma urew l-ebda kampjun barra l-medda ta' 85-115% tal-kontenut medju.
English: As outlined in the CVMP's Note for guidance (EMEA/CVMP/080/95) a description should be provided of how the pre-mix is to be incorporated into the feedingstuff.
Maltese: Kif stipulat fin-Nota tas-CVMP għal gwida (EMEA/CVMP/080/95), għandha tiġi pprovduta deskrizzjoni ta' kif it-taħlita minn qabel għandha tiġi inkorporata fl-għalf.
English: Hungary Eli Lilly Regional Operations GmbH
Maltese: L-Ungerija Eli Lilly Regional Operations GmbH
English: Inclusion rates
Maltese: Rati ta' inklużjoni
English: Note: The text in grey shading below is not applicable for MICLOZAN 200 pre-mix (see Annex I):
Maltese: Nota: It-test ta' hawn taħt bl-isfond griż mhuwiex applikabbli għal MICLOZAN 200 taħlita minn qabel (ara l-Anness I):
English: Taking into account the information provided, it is considered that the target of 200 g of tilmicosin per ton of rabbit pelleted feed (200 ppm) could be achieved with the appropriate inclusion rate of the tilmicosin 40 g pre-mix, tilmicosin 100 g pre-mix and tilmicosin 200 g pre-mix, and with all of the pack sizes mentioned.
Maltese: Wara li ġie kkunsidrat it-tagħrif ipprovdut, tqies li l-mira ta' 200 g tilmicosin għal kull tunnellata ta' għalf f'gerbubiet għall-fniek (200 ppm) tista' tinkiseb bir-rata ta' inklużjoni xierqa ta' tilmicosin 40 g taħlita minn qabel, tilmicosin 100 g taħlita minn qabel u tilmicosin 200 g taħlita minn qabel, u fiddaqsijiet kollha tal-pakketti msemmija.
English: Homogeneity was demonstrated as the coefficient of variation was less than 5 % in all the cases tested.
Maltese: varjazzjoni kien inqas minn 5 % fil-każijiet kollha ttestjati.
English: Additionally, these veterinary medicinal products are indicated in rabbits for the prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to tilmicosin.
Maltese: Barra minn hekk, dawn il-prodotti mediċinali veterinarji huma indikati fil-fniek għall-prevenzjoni u t-trattament ta' marda respiratorja kkawżata minn Pasteurella multocida u Bordetella bronchiseptica, suxxettibbli għal tilmicosin.
English: The approved dose is 12.5 mg/kg bw/day for 7 days, which is achieved by incorporating tilmicosin at a rate of 200 g per ton of finished feed (equivalent to 200 ppm).
Maltese: Id-doża approvata hija ta' 12.5 mg/kg bw/jum għal 7 ijiem, li tinkiseb billi tilmicosin jiġi inkorporati b'rata ta' 200 g għal kull tunnellata ta' għalf lest (ekwivalenti għal 200 ppm).