FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance is levofloxacin.
Maltese: Is-sustanza attiva hija levofloxacin.
English: Linearity
Maltese: Linejarità
English: Extrapyramidal disorder Ageusia
Maltese: Disturbi ekstrapiramidali Ageusia
English: Frequencies in this table are defined using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).
Maltese: Il- frekwenzi f'din it-tabella huma mfissra hekk: komuni ħafna (1/10), komuni (1/100, <1/10), mhux komuni (1/1000, <1/100), rari (1/10000, <1/1000), rari ħafna (<1/10000), mhux magħrufa (ma tistax tittieħed stima mid-dejta disponibbli).
English: Interference with laboratory test
Maltese: Interferenza ma' testijiet tal-laboratorju
English: • Non-steroidal anti-inflammatory drugs (NSAIDS) - used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen, indomethacin.
Maltese: • Mediċini li mhumiex sterojdi kontra l-infjammazzjoni (NSAIDs) - użati għall-uġigħ u linfjammazzjoni bħal aspirina, ibuprofen, fenbufen, ketoprofen, indomethacin.
English: Patients with G-6- phosphate dehydrogenase deficiency
Maltese: Pazjenti li għandhom defiċjenza ta' G-6-phosphate dehydrogenase
English: Anaerobic bacteria Bacteroides fragilis
Maltese: Batterji li huma anaerobiċi Bacteroides fragilis
English: Impaired renal function (creatinine clearance 50 ml/min)
Maltese: Indeboliment fil-funzjoni renali (tneħħija tal-krejatinina 50 ml/min)
English: Rare (≥1/10,000 to <1/1,000)
Maltese: Rari (≥1/10,000 sa
English: Aerobic Gram-positive bacteria Bacillus anthracis
Maltese: Batterji li huma aerobiċi u Gram-positive Bacillus anthracis
English: For incompatibilities see section 6.2 and compatibility with other infusion solutions see section 6.6.
Maltese: Għal inkompatibbilitajiet ara sezzjoni 6.2 u għal kompatibbilitajiet ma' soluzzjonijiet għall-infużjoni oħra ara sezzjoni 6.6.
English: 50 - 20 ml/min then: 125 mg/24 h then: 250 mg/24 h then: 250 mg/12 h
Maltese: 50 - 20 ml/min imbagħad: 125 mg/24 h imbagħad: 250 mg/24 h imbagħad: 250 mg/12 h
English: This includes medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (‘macrolide' antibiotics such as erythromycin, azithromycine and clarithromycin).
Maltese: Dawn jinkludi mediċini użati għat-ritmu tal-qalb mhux normali (antiarritmiċi bħal quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide u amiodarone), għad-dipressjoni (antidipressivi triċikliċi bħal amitriptyline u imipramine), għal disturbi psikjatriċi (antipsikotiċi), u għall-infezzjonijiet batterjali (antibijotiċi tal-klassi ‘makrolidi' bħal erythromycin, azithromycine u clarithromycin)
English: CARDBOARD / BOTTLE OF 100 ML LABEL / BOTTLE OF 100 ML
Maltese: KARTUN / FLIXKUN TA' 100 ML TIKKETTA / FLIXKUN TA' 100ML
English: Total duration of treatment1 (according to severity)
Maltese: Żmien totali tal-kura1 (skont is-severità)
English: • The 100 ml bottle is available in packs of 1, 5 and 20
Maltese: • Il-flixkun ta' 100 ml huwa f'pakketti ta' 1, 5 u 20
English: • Prostate gland infection: 500 mg once daily
Maltese: • Infezzjoni tal-prostata: 500 mg darba kuljum
English: Aerobic Gram-positive bacteria Enterococcus faecium
Maltese: Batterji li huma aerobiċi u Gram-positive Enterococcus faecium
English: • Infection of urinary tract, including your kidneys or bladder: 500 mg once daily
Maltese: • Infezzjoni tas-sistema urinarja, inkluż kliewi jew bużżieqa tal-urina: 500 mg darba kuljum
English: 1 bottle of 50 ml 5 bottles of 50 ml
Maltese: 5 fliexken ta' 50 ml
English: Tendon disorders (see sections 4.3 and 4.4) including tendinitis (e.g. Achilles tendon) Muscular weakness which may be of special importance in patients with myasthenia gravis (see section 4.4)
Maltese: Disturbi fit-tendini (ara sezzjonijiet 4.3 u 4.4) inkluż tendinite (eż. tendin ta' Akille) Dgħufija fil-muskoli li jistgħu jkunu ta' importanza partikolari f'pazjenti b'myasthenia gravis (ara sezzjoni 4.4)
English: Dose regimen 250 mg/24h
Maltese: 250 mg/24h
English: Psychotic reactions
Maltese: Reazzjonijiet Psikotiċi
English: Tavanic 5 mg/ml solution for infusion
Maltese: Tavanic 5mg/ml soluzzjoni għall-infużjoni
English: 1 bottle of 100 ml 5 bottles of 100 ml 20 bottles of 100 ml
Maltese: Għall-flixkun ta' 100 ml: flixkun wieħed ta' 100 ml 5 fliexken ta' 100 ml 20 flixkun ta' 100ml
English: This medicinal product contains 7.8 mmol (181 mg) sodium per 50 ml dose and 15.8 mmol (363 mg) per 100 ml dose.
Maltese: Dan il-prodott mediċinali għandu 7.8 mmol (181 mg) ta' sodju għal kull doża ta' 50 ml u 15.
English: Also contains: sodium chloride, sodium hydroxide, hydrochloric acid and water for injection.
Maltese: L-ingredjenti l-oħra huma: sodium chloride, sodium hydroxide, hydrochloric acid u ilma għallinjezzjoni.
English: 50 ml of solution for infusion contain 7.9 mmol (181 mg) sodium.
Maltese: 50 ml ta' soluzzjoni għall-infużjoni fih 7.9 mmol (181 mg) ta' sodium 100 ml ta' soluzzjoni għall-infużjoni fih 15.
English: Aerobic Gram-negative bacteria Eikenella corrodens Haemophilus influenzae Haemophilus para-influenzae Klebsiella oxytoca Moraxella catarrhalis Pasteurella multocida Proteus vulgaris Providencia rettgeri
Maltese: Haemophilus influenzae Haemophilus para-influenzae Klebsiella oxytoca
English: 4.6 Fertility, pregnancy and lactation
Maltese: .6 Fertilitá, tqala u treddigħ
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injection
Maltese: Sodium hydroxide (għall-aġġustament tal-pH) Hydrochloric acid (għall-aġġustament tal-pH) Ilma għall-injezzjoni.
English: The infusion time must be at least 30 minutes for 250 mg or 60 minutes for 500 mg Tavanic solution for infusion (see section 4.4).
Maltese: Il-ħin tal-infużjoni jrid ikun mill-anqas 30 minuta għal 250 mg jew 60 minuta għal 500 mg soluzzjoni għall-infużjoni Tavanic (ara sezzjoni 4.4).
English: The following dose recommendations can be given for Tavanic: Dosage in patients with normal renal function (creatinine clearance > 50 ml/min) Indication
Maltese: Dożaġġ f'pazjenti b'funzjoni renali normali (tneħħija tal-krejatinina > 50ml/min) Indikazzjoni
English: Complicated urinary tract infections
Maltese: Infezzjonijiet ikkumplikati tassistema urinarja
English: • attacks of porphyria in patients with porphyria
Maltese: • attakki ta' porfirija f'pazjenti bil-porfirija
English: Pack sizes of 1, 5 and 20 bottles.
Maltese: Daqsijiet ta' pakketti ta' flixkun, 5 fliexken u 20 flixkun.
English: Each bottle of 50 ml solution for infusion contains 250 mg levofloxacin as levofloxacin hemihydrate Each bottle of 100 ml solution for infusion contains 500 mg levofloxacin as levofloxacin hemihydrate
Maltese: 50 ml ta' soluzzjoni għall-infużjoni fih 250 mg ta' levofloxacin bħala levofloxacin hemihydrate 100 ml ta' soluzzjoni għall-infużjoni fih 500 mg ta' levofloxacin bħala levofloxacin hemihydrate
English: Pharmacotherapeutic group: quinolone antibacterials, fluoroquinolones, ATC code: J01MA12 Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone class and is the S (-) enantiomer of the racemic active substance ofloxacin.
Maltese: Levofloxacin huwa aġent antibatterjali sintetiku tal-klassi fluoroquinolone u hu S (-) enantiomer tassustanza attiva raċemika ofloxacin.
English: • The 50 ml bottle is available in packs of 1 and 5
Maltese: • Il-flixkun ta' 50 ml huwa f'pakketti ta' 1 u 5
English: # Methicillin-resistant S. aureus are very likely to possess co-resistance to fluoroquinolones, including levofloxacin.
Maltese: # S. aureus li huwa reżistenti għal methicillin x'aktarx ikollhom reżistenza għal fluoroquinolones, inkluż levofloxacin.
English: According to toxicity studies in animals or clinical pharmacology studies performed with supra-therapeutic doses, the most important signs to be expected following acute overdose of Tavanic solution for infusion are central nervous system symptoms such as confusion, dizziness, impairment of consciousness, and convulsive seizures, increases in QT interval.
Maltese: Skont studji ta' tossiċità fl-annimali jew studji kliniċi farmakoloġiċi li saru b'dożi supra-terapewtiċi, issinjali l-aktar importanti li huma mistennija li jiġru wara doża eċċessiva ta' Tavanic soluzzjoni għallinfużjoni huma sintomi tas-sistema nervuża ċentrali bħal konfużjoni, sturdament, indeboliment tassensi, u aċċessjonijiet konvulsivi, żidiet fl-intervall QT.
English: Tavanic solution for infusion is compatible with the following solutions for infusion: 0.9% sodium chloride solution.
Maltese: Is-soluzzjoni għall-infużjoni Tavanic hija kompatibbli mas-soluzzjonijiet għall-infużjoni li ġejjin: 0.9% soluzzjoni ta' sodium chloride. injezzjoni ta' 5% glucose.
English: NAME OF THE MEDICINAL PRODUCT Tavanic 5 mg/ml solution for infusion levofloxacin
Maltese: TAVANIC 5mg/ml soluzzjoni għall-infużjoni levofloxacin
English: Penetration into tissues and body fluids:
Maltese: Penetrazzjoni fis-tessuti u fluwidi tal-ġisem:
English: Package leaflet: Information for the user Tavanic 5 mg/ml solution for infusion levofloxacin
Maltese: Informazzjoni għall-utent Tavanic 5 mg/ml soluzzjoni għall-infużjoni levofloxacin
English: Anorexia Hypoglycaemia particularly in diabetic patients (see section 4.4)
Maltese: Anoreksja Ipogliċemija speċjalment f'pazjenti dijabetiċi (ara sezzjoni 4.4)
English: As with all quinolones, disturbances in blood glucose, including both hypoglycaemia and hyperglycaemia have been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycaemic agent (e.g., glibenclamide) or with insulin.
Maltese: Bħal quinolones oħra, ġew irrapportati disturbi fiz-zokkor fid-demm, u dan jinkludi kemm l u anke ipergliċemija, normalment f'pazjenti dijabetiċi li jirċievu kura konkomittanti ma'xi mediċina ipogliċemika orali (eż. glibenclamide) jew mal-insulina.
English: • in patients with epilepsy,
Maltese: • f'pazjenti epilettiċi
English: • Infection of skin and underneath the skin, including muscles: 500 mg once or twice daily
Maltese: • Infezzjoni tal-ġilda u taħt il-ġilda, inklużi muskoli: 500 mg darba jew darbtejn kuljum
English: • Inflammation of a vein
Maltese: • Infjammazzjoni tal-vina
English: Agitation
Maltese: Astenja
English: CARDBOARD / BOTTLE OF 50 ML LABEL / BOTTLE OF 50 ML
Maltese: ML TIKKETTA / FLIXKUN TA' 50ML
English: 100 ml of solution for infusion contain 15.8 mmol (363 mg) sodium.
Maltese: 8 mmol (363 mg) ta' sodium
English: Tavanic solution for infusion is available in two presentations: 250 mg in a 50 ml glass bottle and 500 mg in a 100 ml glass bottle.
Maltese: Hemm żewġ preżentazzjonijiet tas-soluzzjoni għall-infużjoni Tavanic: 250 mg fi flixkun tal-ħġieġ ta' 50 ml u 500 mg fi flixkun tal-ħġieġ ta' 100 ml.
English: Having too much Tavanic may cause the following effects to happen: convulsive fits (seizures), feeling confused, dizzy, less conscious, having tremor and heart problems - leading to uneven heart beats as well as feeling sick (nausea).
Maltese: Jekk tingħata wisq Tavanic, jistgħu jseħħu l-effetti li ġejjin: aċċessjonijiet konvulsivi (puplesiji), tħossok konfuż, sturdut, inqas konxju, jkollok rogħda u problemi tal-qalb li jwasslu għal taħbit irregolari tal-qalb kif ukoll tħossok ma tiflaħx (dardir).
English: • Attacks of porphyria in people who already have porphyria (a very rare metabolic disease)
Maltese: • L-attakki ta' porfirija f'persuni li diġà għandhom porfirija (marda metabolika rari ħafna)
English: No adjustment of dose is required in the elderly, other than that imposed by consideration of renal function (see section 4.4 “Tendinitis and tendon rupture” and “QT interval prolongation”).
Maltese: M'hemmx bżonn ta' aġġustament fid-doża fl-anzjani, ħlief aġġustament li jrid isir minħabba l-funzjoni renali (Ara sezzjoni 4.4 “Tendinite u tiċrit tat-tendini” u “l-intervall QT imtawwal”).
English: • It will be given to you by a doctor or nurse as an injection.
Maltese: • Tingħata lilek minn tabib jew infermier bħala injezzjoni.
English: Biotransformation
Maltese: Mikrobu
English: Tavanic solution for infusion contains a medicine called levofloxacin.
Maltese: Is-soluzzjoni għall-infużjoni Tavanic fiha mediċina msejħa levofloxacin.
English: Methicillin-resistant S. aureus are very likely to possess co-resistance to fluoroquinolones, including levofloxacin.
Maltese: S. aureus li hu reżistenti għal methicillin x'aktarx li jkollu wkoll reżistenza għal fluoroquinolones, inkluż levofloxacin.
English: Jaundice and severe liver injury, including fatal cases with acute liver failure, primarily in patients with severe underlying diseases (see section 4.4) Hepatitis
Maltese: Suffejra u ħsara severa filfwied inkluż każijiet fatali ta' insuffiċjenza akuta talfwied, primarjament f'pazjenti morda b'mard serju (ara sezzjoni 4.4) Epatite
English: Caution should be taken when using fluoroquinolones, including levofloxacin, in patients with known risk factors for prolongation of the QT interval such as, for example: - congenital long QT syndrome - concomitant use of drugs that are known to prolong the QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics).
Maltese: Wieħed għandu joqgħod attent meta jintużaw fluoroquinolones, inkluż levofloxacin, f'pazjenti li għandhom riskju magħruf li jitwal l-intervall QT bħal, per eżempju: - sindromu ta' QT twil konġenitali - l-użu konkomitanti ta' mediċini li huma magħrufa li jtawlu l-intervall QT (eż. antiarritmiċi Klassi
English: Aerobic Gram-negative bacteria Acinetobacter baumannii Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Morganella morganii Proteus mirabilis Providencia stuartii Pseudomonas aeruginosa Serratia marcescens
Maltese: Anthrax li tittieħed bin-nifs: L-użu fil-bnedmin huwa bbażat fuq is-suxxettibilità in vitro ta' Bacillus anthracis u fuq dejta miġbura minn esperimenti fuq annimali flimkien ma' dejta limitata tal-bniedem.
English: The recommended infusion time of at least 30 minutes for 250 mg or 60 minutes for 500 mg Tavanic solution for infusion should be observed.
Maltese: Il-ħin tal-infużjoni rakkomandat ta' mill-anqas 30 minuta għal 250 mg jew 60 minuta għal 500 mg Tavanic soluzzjoni għall-infużjoni għandu jinżamm.
English: Mycoplasma hominis Ureaplasma urealyticum
Maltese: • Dgħufija ġenerali
English: 100 ml type I glass bottle with flanged aluminium cap, chlorobutyl rubber stopper and tear-off polypropylene lid. Each bottle contains 100 ml solution for infusion.
Maltese: Flixkun tal-ħġieġ tat-tip I ta' 100 ml bl-għatu tal-aluminju bix-xoffa, b'tapp tal-gomma chlorobutyl u għatu tal-polypropylene li jista' jiċċarrat biex jinfetaħ.
English: 50 ml type I glass bottle with flanged aluminium cap, chlorobutyl rubber stopper and tear-off polypropylene lid. Each bottle contains 50 ml solution for infusion.
Maltese: Flixkun tal-ħġieġ tat-tip I ta' 50 ml bl-għatu tal-aluminju bix-xoffa, b'tapp tal-gomma chlorobutyl u għatu tal-polypropylene li jista' jiċċarrat biex jinfetaħ.
English: The risk of tendinitis and tendon rupture is increased in patients aged over 60 years, inpatients receiving daily doses of 1000 mg and in patients using corticosteroids.
Maltese: tendinite u ta' tiċrit tat-tendini jogħla f'pazjenti ta' akter minn 60 sena, f'pazjenti li jirċievu dożi ta' kuljum ta' 1000 mg u f'pazjenti li jużaw il-kortikosterojdi.
English: Rash
Maltese: Oħrajn
English: 500 mg once daily
Maltese: 500 mg darba kuljum
English: The time to switch from intravenous to oral treatment depends on the clinical situation but is normally 2 to 4 days.
Maltese: Il-ħin meta taqleb minn kura fil-vina għal kura orali jiddependi mis-sitwazzjoni klinika imma normalment huwa ta' jumejn sa erbat ijiem.
English: Levofloxacin is contraindicated in patients with a history of epilepsy (see section 4.3) and, as with other quinolones, should be used with extreme caution in patients predisposed to seizures or concomitant treatment with active substances that lower the cerebral seizure threshold, such as theophylline (see section 4.5).
Maltese: Levofloxacin huwa kontra-indikat f'pazjenti li għandhom storja ta' epilessija (ara sezzjoni 4.3) u, bħal fil-każ ta' quinolones oħra, din is-soluzzjoni għandha tintuża b'kawtela kbira f'pazjenti li huma predisposti għall-aċċessjonijiet jew jekk ikun hemm kura eżistenti b'mediċini li jbaxxu l-limitu ċerebrali li jkun hemm xi aċċessjoni, bħal per eżempju theophylline (ara sezzjoni 4.5).
English: One ml of solution for infusion contains 5 mg of levofloxacin.
Maltese: Kull millilitru tas-soluzzjoni għall-infużjoni fiha 5 mg ta' levofloxacin.
English: Coagulation tests, therefore, should be monitored in patients treated with vitamin K antagonists (see section 4.4)
Maltese: Għalhekk, testijiet tal-koagulazzjoni għandhom jiġu mmonitorjati f'pazjenti li qed jieħdu kura b'antagonisti tal-vitamina K (ara sezzjoni 4.4)
English: 50 ml of solution for infusion contains 250 mg of levofloxacin as levofloxacin hemihydrate.
Maltese: Kull flixkun ta' 50 ml soluzzjoni għall-infużjoni fih 250 mg levofloxacin bħala levofloxacin hemihydrate
English: Rhabdomyolysis Tendon rupture (e.g. Achilles tendon) (see sections 4.3 and
Maltese: Mhux magħrufa (ma tistax tittieħed stima mid-dejta disponibbli)
English: Cases of hepatic necrosis up to fatal hepatic failure have been reported with levofloxacin, primarily in patients with severe underlying diseases, e.g. sepsis (see section 4.8).
Maltese: Ġew irrapportati każijiet ta' nekrożi fil-fwied sa insuffiċjenza tal-fwied li hija ta' periklu għall-ħajja ma' levofloxacin, primarjament f'pazjenti morda b'mard serju, eż. sepsis (ara sezzjoni 4.8).
English: Haemodialysis, including peritoneal dialysis and CAPD, are not effective in removing levofloxacin from the body.
Maltese: Emodijalisi, inkluż dijalisi peritoneali u CAPD, mhumiex effettivi fit-tneħħija tal-levofloxacin mill-ġisem.
English: This medicine contains181 mg of sodium per 250 mg dose.
Maltese: Is-soluzzjoni għall-infużjoni Tavanic fih sodium Din il-mediċina fiha181 mg ta' sodium f'kull doża ta' 250 mg.
English: • Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity)
Maltese: • Sensittività akbar tal-ġilda tiegħek għax-xemx u d-dawl ultraviolet (fotosensittività)
English: The identification and antimicrobial susceptibility tests on any such isolate must be repeated and if the result is confirmed the isolate must be sent to a reference laboratory.
Maltese: L-identifikazzjoni u s-suxxettibilità għal aġenti antimikrobjali ta' kwalunkwe mikrobu ta' dan it-tip għandhom jiġi ripetuti u jekk ir-riżultat huwa kkonfermat, ilmikrobu għandu jiġi mibgħut lill-laboratorju riferibbli.
English: • Inhalation Anthrax: postexposure prophylaxis and curative treatment (see section 4.4).
Maltese: Anthrax li tittieħed bin-nifs: profilassi wara espożizzjoni u kura għall-fejqan (ara sezzjoni 4.4)
English: • Pain, including pain in the back, chest and extremities
Maltese: • Uġigħ, inkluż uġigħ fid-dahar, sider u estremitajiet
English: Mixture with other solutions for infusion:
Maltese: Taħlita ma' soluzzjonijiet għall-infużjoni oħra:
English: ATCvet code: QI01AE04.
Maltese: QI01AE04.
English: Date of latest renewal: 15/05/2017.
Maltese: Data tal-aħħar tiġdid: 15/05/2017.
English: 2000 Rockford Road, Charles City
Maltese: Rockford Road, Charles City IA 50616
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: 6.1 Lista ta' eċipjenti
English: Date of first authorisation: 15/06/2012.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 15/06/2012.
English: EU/2/12/140/001 EU/2/12/140/002 EU/2/12/140/003 EU/2/12/140/004 EU/2/12/140/005 EU/2/12/140/006 EU/2/12/140/007 EU/2/12/140/008
Maltese: EU/2/12/140/006 EU/2/12/140/007 EU/2/12/140/008
English: Administration
Maltese: Amministrazzjoni
English: To stimulate active immunity to Escherichia coli serotype O78.
Maltese: Sabiex tiġi stimulata immunità attiva għal Escherichia coli serotip O78
English: Onset of immunity:
Maltese: Iż-żmien ta' immunità:
English: Lot{number}
Maltese: Jiskadi {xahar/sena}
English: Apply the usual aseptic precautions to all administration procedures.
Maltese: Applika l-prekawzjonijiet asettiċi tas-soltu għall-proċeduri amministrattivi.
English: 1 x 2,500 doses, 10 x 2,500 doses 1 x 5,000 doses, 10 x 5,000 doses 1 x 10,000 doses, 10 x 10,000 doses 1 x 20,000 doses, 10 x 20,000 doses
Maltese: 1 x 2,500 doża, 10 x 2,500 doża 1 x 5,000 doza, 10 x 5,000 doża 1 x 10,000 doża, 10 x 10,000 doża 1 x 20,000 doża 10 x 20,000 doża
English: Store and transport refrigerated (2 °C - 8 °C).
Maltese: Aħżen u ttrasporta fil-friġġ (2 °C - 8 °C).
English: Live E. coli: 5.2 x 106 - 9.1 x 108 CFU/dose
Maltese: E. coli ħaj: 5.2 x 10 6 - 9.1 x 108 CFU/doża
English: Spray application:
Maltese: Applikazzjoni ta' sprej:
English: As a general rule, apply reconstituted vaccine to chlorine-free and fresh water at the rate of 1,000 doses of the vaccine to 1 litre of water per day of age for 1,000 chickens, e.g. 10 litres would be needed for 1,000 10-day old chickens.
Maltese: Bħala regola ġenerali il-vaċċin rikostitwit għandu jingħata f'ilma frisk mingħajr klorin b'rata ta' 1,000 doża ta' vaċċin ma' litru ta' ilma għal kull jum età għal 1,000 tiġieġa, eż. hemm bżonn ta' 10 litri għal 1,000 tiġieġa ta' 10 ijiem.
English: Half-fill the vial with chlorine-free water at room temperature.
Maltese: Imla nofs il-kunjett b'ilma mingħajr klorin f'temperatura tal-kamra.
English: 2,500 doses 5,000 doses 10,000 doses 20,000 doses
Maltese: 2,500 doża 5,000 doża 10,000 doża 20,000 doża
English: 5.2 x 106 - 9.1 x 108 CFU/ds
Maltese: 5.2 x 106 - 9.1 x 108 CFU *
English: Name and address of the manufacturer responsible for batch release Zoetis Manufacturing & Research Spain, S.L.
Maltese: Isem u indirizz tal-manifattur responsabbli mill-ħruġ tal-lott Zoetis Manufacturing & Research Spain, S.L. Ctra.
English: Name and address of the manufacturer of the biological active substance Zoetis Inc.
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva Zoetis Inc.
English: For active immunisation of broiler chickens, future layer/breeders and turkeys in order to reduce mortality and lesions (pericarditis, perihepatitis, airsacculitis) associated with Escherichia coli serotype O78.
Maltese: INDIKAZZJONI(JIET) Għall-immunizzazzjoni attiva ta' tiġieġ tas-simna u tal-bajd/trobbija futuri u dundjani sabiex jitnaqqsu limwiet u l-ġrieħi (perikardite, periepatite, infezzjoni tal-airsac) assoċjati ma' Escherichia coli serotip O78.
English: Type I borosilicate glass vial of 10 ml for 2,500 and 5,000 dose-presentations and 50 ml for 10,000 and 20,000 dose-presentations with a bromobutyl rubber stopper sealed with aluminium crimp caps.
Maltese: Kunjett tal-ħġieġ tal-borosilikat tip I ta' 10 ml għal preżentazzjonijiet ta' 2,500 u 5,000 doża u ta' 50 ml għal preżentazzjonijiet ta' 10,000 u 20,000 doża b'tapp tal-lastku ta' bromobutyl issiġillat b'għotjien talaluminju.
English: A cross protection study showed reduction of incidence and severity of airsacculitis caused by E. coli serotypes O1, O2 and O18 for spray application for chickens.
Maltese: Studju ta' protezzjoni inkroċjat wera tnaqqis fl-inċidenza u s-severità ta' infezzjoni tal-airsac kaġunata mis-serotipi O1, O2 u O18 ta' E. coli b'applikazzjoni permezz ta' bexx għat-tiġieġ.
English: Do not mix with any other veterinary medicinal product.
Maltese: M'għandekx tħallat ma' prodotti mediċinali veterinarji oħra.
English: Turkeys: duration of immunity has not been established.
Maltese: Dundjani: iż-żmien tal-immunità ma ġiex stabbilit.