qanastek/EMEA-V3 huggingface dataset:
Treatment of acute otitis externa, and acute exacerbation of recurrent otitis externa associated with bacteria susceptible to gentamicin and fungi susceptible to miconazole in particular Malassezia pachydermatis.
Il- kura ta ’ otite akuta esterna, u otite rikurrenti esterna li tkun marret għal agħar, assoċjata ma ’ bakterja suxxettibbli għal ġentamiċin u fungi suxxettibbli għal mikonażol speċjalment Malasseżija pakidermatite.
Do not use in case of hypersensitivity to the active substance or to any of the excipients, to corticosteroids, to other azole antifungal agents and to other aminoglycosides.
Tużax f' każijiet ta 'sensittività eċċessiva għal sustanza attiva jew sustanzi mhux attivi, għal kortikosterojdi, għal aġenti oħra antifungali ażoli u għal aminoglikosidi oħra.
Do not use if the eardrum is perforated.
Tużax jekk it- tanbur tal- widna hu mtaqqab.
Do not use concurrently with substances known to cause ototoxicity.
Tużax flimkien ma ’ sustanzi li huma magħrufa li jikkawżaw ototossiċità.
In this case, treatment should be stopped.
Jekk dan jiġri il- kura għandha titwaqqaf.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
DOŻA GĦAL KULL SPEĊJE, MODI U METODU TA 'AMMINISTRAZZJONI
The recommended dosage is 1 ml of the veterinary medicinal product per ear once a day for five consecutive days.
Id- dożaġġ rrakkomandat hu ta ’ 1 ml tal- prodott mediċinali veterinarju f’ kull widna nfettata darba kuljum għal ħamest ijiem konsekuttivi.
Introduce the atraumatic canula in the ear canal.
Daħħal il- kanula atrawmatika fil- kanal tal- widna.
ins
ins Doża waħda / widna / kull ġurnata għal ħamest ijiem
/ ear / day for 5 days
ikun xi jkun id- daqs
After application, the base of the ear may be massaged briefly and gently to allow the preparation to penetrate to the lower part of the ear canal.
Wara l- għoti, il- bażi tal- widna għandha mnejn tkun immassaġġjata għal ftit ħin u b’ mod ġentili biex tħalli l- preparazzjoni tippenetra il- parti t’ isfel tal- kanal tal- widna.
Do not use after the expiry date, which is stated on the label.
Tużax wara d- data tal- iskadenza fuq it- tikketta.
Once opened use within 10 days.
17/ 20 La darba jinfetaħ uża fi żmien 10 ijiem.
Bacterial and fungal otitis is often secondary in nature and appropriate diagnosis should be used to determine the primary factors involved.
Jekk ikun hemm sensittività eċċessiva għal kwalunkwe komponiment, il- kura għandha titwaqqaf u tinbeda terapija adegwata.
Use of the veterinary medicinal product should be based on identification of infecting organisms and susceptibility testing and take into account official and local antimicrobial policies.
L- użu ta ’ prodott mediċinali veterinarju għandu jkun ibbażat fuq l- identifikazzjoni ta ’ organizmi li jinfettaw u l- ittestjar għas- suxxettibilità u jieħu nkonsiderazzjoni l- policies uffiċjali u lokali antimikrobjali L- użu ta ’ prodott mediċinali veterinarju li jiddevja mill- istruzzjonijiet mogħtija fil- SPC għandhom mnejn iżidu il- prevalenza ta ’ batterja u fungi li huma reżistenti għal gentamiċin u mikonażol rispettivament u għandhom mnejn inaqqsu l- effettività tal- kura permezz ta ’ aminoglikosidi u aġenti antifungali ażoli, minħabba il- potenzjal ta ’ reżistenza salib F’ każ ta ’ otite parasitika, għandha tingħata kura akariċidjali adegwata.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Ġentamiċin hi magħrufa li hi assoċjata ma ’ ototossiċità meta tingħata permezz ta ’ mod sistematiku f’ dożi ogħla minn dożi terapewtiċi.
Systemic absorption of hydrocortisone aceponate, gentamicin sulphate and miconazole nitrate being negligible, it is unlikely for teratogenic, foetotoxic or maternotoxic effects to occur at the recommended dosage in dogs.
Evita kuntatt mal- għajnejn.
Use only accordingly to the risk-benefit assessment by the responsible veterinarian.
F’ każ ta ’ irritazzjoni tal - għajnejn, fittex tabib.
Compatibility with ear cleaners has not been demonstrated.
Jekk tibilgħu b’ mod aċċidentali, fittex tabib mill- ewwel u qis li turih il- fuljett ta 'informazzjoni li jkun fih ġewwa jew it- tikketta.
In case of accidental skin contact, it is recommended to wash thoroughly with water.
Is- sigurtà tal- prodott mediċinali veterinarju ma ġietx stabbilita waqt it- tqala u fi żmien il- ħalib.
In case of accidental contact, rinse with abundant quantities of water.
Uża biss skond kif il- veterinarju responsabbli iqis il- benefiċċju/ riskju tal- prodott.
In case of eye irritation, seek medical advice.
Il- kompattibilità ma ’ prodotti oħra li jnaddfu l- widnejn ma ġietx murija.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Fil- każ ta ’ klieb li kienu kkurati b’ doża terapewtika għal għaxart ijiem konsekuttivi, il- livelli tal - kortiżol tas- serum naqsu minn ħamest ijiem ‘ l quddiem u ġew lura għal valuri normali fi żmien għaxart ijiem wara t- tmiem tat- trattament.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall - Mediċini (EMEA) http: // www. emea. europa. eu /.
The veterinary medicinal product is a fixed combination of three active substances: antibiotic, antifungal and corticosteroid.
Il- prodott mediċinali veterinarju hu taħlita fissa ta ’ tlett sustanzi attivi: kortikosterojdi, antifungali u antibijotiku.
11/ A H-1021 Budapest Tel.:
Tel.:
SUMMARY OF PRODUCT CHARCTERISTICS
KARATTERISTIĊI TAL- PRODOTT FIL- QOSOR
Econor 50% premix for medicated feed for pigs Econor 10% premix for medicated feed for pigs Econor 1% premix for medicated feed for pigs Econor 0.5% premix for medicated feed for pigs
Econor 50% taħlita mediċinali ta 'l- ikel lesta għall- majjali Econor 10% taħlita mediċinali ta' l- ikel lesta għall- majjali Econor 1% taħlita mediċinali ta 'l- ikel lesta għall- majjali Econor 0. 5% taħlita mediċinali ta' l- ikel lesta għall- majjali
QUALITATIVE AND QUANTITATIVE COMPOSITION
KOMPOŻIZZJONI KWALITATTIVA U KWANTITÀTTIVA
Econor contains valnemulin in the form of valnemulin hydrochloride.
Econor fih valnemulin f' għamla ta 'valnemulin hydrochloride.
equivalent valnemulin base
ekwivalenti għal bażi ta 'valnemulin
Excipients
Hypromellose u Hypromellose u Hypromellose u Hypromellose Sustanzi mhux attivi
Hypromellose and talc
talc
Hypromellose and talc Colloidal anhydrosus silicum Isopropyl myristate Lactose
talc talc Colloidal Colloidal anhydrosus anhydrosus silicum silicum Isopropyl Isopropyl myristate myristate Lactose Lactose
Hypromellose and talc Colloidal anhydrosus silicum Isopropyl myristate Lactose
u talc Colloidal anhydrosus silicum Isopropyl myristate Lactose
Hypromellose and talc Colloidal anhydrosus silicum Isopropyl myristate Lactose
Għal- lista sħiħa ta ’ l- ingredjenti (mhux attivi), ara s- sezzjoni 6. 1.
Premix for medicated feedingstuff
Taħlita mediċinali lesta bħala għalf
Pigs
Majjali
4.2 Indications for use
4. 2 Indikazzjonijiet għal użu tal- prodott li jispeċifikaw l- ispeċi li fuqhom se jintuża l- prodott
Econor 10% and 50%:
Econor 10% u 50%:
The treatment and prevention of swine dysentery.
It- trattament u l- prevenzjoni ta 'diżenterija tal- majjali.
The treatment of clinical signs of porcine proliferative enteropathy (ileitis).
It- trattament ta ’ sinjali kliniċi ta ’ enteropatija proliferattiva (ileitis) tal- majjali.
The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been diagnosed in the herd.
Il- prevenzjoni ta ’ sinjali kliniċi ta ’ spirochaetosis kolonika (kolité) tal- majjali meta l- marda tkun ġiet dijanjostikata fil- merħla.
Treatment and prevention of swine enzootic pneumonia.
It- trattament u l- prevenzjoni ta ’ pnewmonja enżootika tal- majjali.
At the recommended dosage of 10 - 12 mg/ kg bodyweight lung lesions and weight loss are reduced, but infection with Mycoplasma hyopneumoniae is not eliminated.
Fid- dożi rakkomandati ta ’ 10 – 12 mg/ kg piż korporali leżjonijet fil- pulmun u telf fil- piż huma mnaqqsa, imma l- infezzjoni b’ Mycoplasma hyopneumoniae mhix eliminata.
2 Econor 0.5% and 1%:
2 Econor 0. 5% u 1%:
For the treatment and prevention of swine dysentery.
It- trattament u l- prevenzjoni ta 'diżenterija tal- majjali.
Do not administer the product to pigs receiving ionophores.
Tamministrax il- prodott lill- majjali li qed jirċievu ionophores.
Valnemulin should not be administered to rabbits because of its toxicity in this species.
Valnemulin m’ għandux jingħata lill- fniek minħabba t- tossiċità f’ din l- ispeċi.
4.5 Special precaution(s) for use
4. 5 Prekawzjonijiet Speċjali għall- Użu
Special precautions for use in animals Adverse drug reactions have occurred following the use of Econor.
Prekawzjonijiet speċjali għall- użu fl- annimali Kien hemm reazzjonijiet avversi tal- mediċina wara l- użu ta 'Econor.
Their occurrence may be principally restricted to the Scandinavian countries and appears to be mainly associated with breed mixes that include Danish and/ or Swedish Landrace.
Il- każijiet tagħhom jistgħu jkunu ristretti prinċipalment mal- pajjiżi Skandinavi u jidhru li huma marbuta prinċipalment ma 'taħlitiet mnissla li jinkludu id- Danish u/ jew Swedish Landrace.
Extreme care should therefore be taken in the use of Econor in pigs of Scandinavian origin especially of the Danish and Swedish Landrace breeds, and their crossbreeds thereof.
Għalhekk għandha tingħata attenzjoni kbira fl - użu ta 'Econor fil- majjali ta' oriġini Skandinava speċjalment dawk li ġejjin minn razez ta ’ Danish u Swedish Landrace, u t- taħlitiet tagħhom.
Special precautions to be taken by the person administering the veterinary medicinal product to animals When mixing the product and handling the final feed containing the product, direct contact with the skin and mucous membranes should be avoided.
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali Meta tħallat il- prodott u tkun se tuża l- aħħar għalf li jkun fih il- prodott, għandu jiġi evitat il- kuntatt dirett mal- ġilda u r- riti mukużi.
In case of accidental ingestion, seek medical advice immediately and show the product label.
F' każ ta 'inġestjoni aċċidentali, fittex parir mediku minnufih u uri t - tikketta tal- prodott.
People with known hypersensitivity to valnemulin should administer the product with caution.
Persuni li għandhom sensittività għal valnemulin għandhom jamministraw il - prodott b' attenzjoni.
Medication of pigs with Econor has led to the occurrence of adverse reactions in the European Union.
Medikazzjoni tal- majjali b’ Econor wasslet għal każi ta ’ reazzjonijiet avversi fl- Unjoni Ewropea.
Of the cases reported in 1999-2000, the majority occurred in Denmark and Sweden (one case each in Finland and Ireland).
Minn dawk rapportati fl- 1999- 2000, il- maġġoranza seħħew fid- Danimarka u fl- Iżvezja (każ kull wieħed fil- Finlandja u fl- Irlanda).
In these countries, the incidence ranged from 0.03 to 1.76% of all pigs treated.
F’ dawn il- pajjiżi l- inċidenza infirxet minn 0. 03 għal 1. 76% tal - majjali kollha ttrattati.
On affected farms, one third of the pigs treated were affected, with a mortality of 1%.
Fl- irziezet effettwati, terz mill- majjali trattati kienu effettwati, b’ mortalità ta ’ 1%.
Affected pigs are pyrexic, exhibit inappetence, and in severe cases become incoordinated, ataxic and may become recumbent.
Il- majjali effettwati jkollhom id- deni, juru inappetenza, u f’ każijiet serji ma jikkoordinawx, isiru atassiċi u jistgħu jibqgħu mimdudin.
A percentage of such pigs may also suffer oedema or erythema (posterior in distribution), and palpebral oedema.
Perċentwal ta ’ dawn il- majjali jista ’ wkoll jkollhom edema u eritima (f’ distribuzzjoni posterjuri), u edema palpebrali.
The reaction has been studied in controlled trials in susceptible animals.
Ir- reazzjoni ġiet mistħarrġa fi provi kkontrollati f’ annimali suxxettibbli.
Mortality was less than 1%, but might be increased as a result of secondary infections.
Il- mortalità kienet inqas minn 1%, imma tista ’ tiżdied minħabba infezzjonijiet sekondarji.
In the case of an adverse reaction, immediate withdrawal of medication is recommended.
Fil- każ ta ’ reazzjoni avversa, huwa rakkomandat li l- mediċina titwaqqaf minnufih.
Severely affected pigs should be removed to clean dry pens and given symptomatic treatment, including treatment for concurrent disease.
Majjali li jkunu effettwati serjament għandhom jitneħħew u jitpoġġew f’ imqajjel nodfa u xotti u jingħataw trattament simptomatiku inkluż trattament għall- marda konkorrenti.
An epidemiological survey has indicated that there is likely to be an association between the susceptibility to adverse reactions and the Danish and Swedish Landrace breeds, and their crossbreds thereof, especially younger pigs.
Stħarriġ epidemjoloġiku indika li hemm ċans li jkun hemm assoċjazzjoni bejn is- suxxettibilità għal reazzjonijiet avversi u r- razez Danish u Swedish Landrace, u r- razez imħallta tagħhom, speċjalment majjali iżgħar.
Valnemulin is well-accepted in feed, but administered at concentrations above 200 mg valnemulin / kg feed may result in transient reduction in food consumption associated with unpalatability during the first few days of feeding.
Valnemulin huwa aċċettat tajjeb fl- għalf, iżda jekk jingħata f’ konċentrazzjonijet akbar minn 200 mg valnemulin/ kg ta ’ għalf jista ’ jirriżulta fi tnaqqis għaddieni fl- ikkunsmar ta ’ l- ikel assoċjat ma ’ togħma ħażina waqt l- ewwel ftit ġranet tat- tagħlif.
3 4.7 Use during pregnancy and lactation
3 4. 7 Użu fit- Tqala, fi żmien il- ħalib u meta jbidu l- bajd
Whilst studies in rats and mice have not produced any evidence of teratogenic effect, the safety in pregnant and lactating sows has not been established.
Filwaqt li studji fil- firien u l- ġrieden ma pproduċew l- ebda xhieda ta ’ effett teratoġeniku, is- sigurtà fil - majjali nisa tqal u li jkunu qegħdin ireddgħu għadha ma ġietx stabbilita.
Valnemulin has been shown to interact with ionophores such as monensin, salinomycin and narasin and may result in signs indistinguishable from an ionophore toxicosis.
Valnemulin ġie muri li jaħdem ma ’ ionophores bħal monensin, salinomycin u narasin u jista ’ jirriżulta f’ sinjali indistingwibbli minn tossikożi ta ’ l- ionophore.
Animals should not receive products containing monensin, salinomycin or narasin, during or at least 5 days before or after treatment with valnemulin.
L- annimali m’ għandhomx jingħataw prodotti li fihom monensin, salinomycin jew narasin, waqt jew ta ’ l- inqas 5t ijiem qabel u wara t- trattament b’ valnemulin.
Severe growth depression, ataxia, paralysis or death may result.
Jista ’ jirriżulta tnaqqis serju fl- iżvilupp, atassja, paraliżi jew mewt.
4.9 Amounts to be administered and administration route
4. 9 Pożoloġija u metodu ta 'kif għandu jingħata
In feed use.
Jingħata ma 'l- ikel.
The uptake of medicated feed depends on the clinical condition of the animal.
It- teħid ta ’ l- għalf immedikat jiddependi fuq il- kundizzjoni klinika ta ’ l- annimal.
In order to obtain the correct dosage the concentration of Econor has to be adjusted.
Sabiex jinkiseb id - dożaġġ korrett, il- konċentrazzjoni ta ’ Econor għandha tiġi aġġustata.
Inclusion levels may also need to be increased in older pigs or pigs on restricted feed to achieve target dosage.
Livelli t’ inklużjoni jistgħu wkoll jiżdiedu f’ majjali aktar xjuħ jew majjali fuq għalf ristrett biex jintlaħħaq id- dożaġġ mixtieq.
Indication Treatment of
Indikazzjoni Trattament ta '
Dosage (active substance)
Dożaġġ (sustanza attiva)
Application period of medicated feed as the sole daily ration
Il- perijodu t' applikazzjoni ta 'għalf immedikat bħala r- razzjon waħdieni ta' kuljum
Application in feed Incorporation of 75 mg active substance per kg feed with:
Applikazzjoni fl- għalf Inkorporazzjoni ta '75 mg ta' sustanza attiva għal kull kilogramm ta ’ għalf
3-4 mg/ kg
3- 4 mg/ kg piż
Minimum of 7 days and
Minimu ta '7 t' ijiem u
Dysentery
ma ':
bodyweight/ day
korporali/ kulju m
up to 4 weeks or until signs of disease disappear
sa 4 ġimgħat jew sakemm is- sinjali tal - marda jisparixxu
Econor 50% - 150 mg / kg feed Econor 10% - 750 mg / kg feed Econor 1% - 7.5 g / kg feed Econor 0.5% - 15 g / kg feed
Econor 50% - 150 mg/ kg ta ’ għalf Econor 10% - 750 mg/ kg ta ’ għalf Econor 1% - 7. 5 g/ kg ta ’ għalf Econor 0. 5% - 15 g/ kg ta ’ għalf
This dose level is effective in the treatment of clinical disease, but higher dosages or longer duration of treatment may be necessary for complete elimination of infection.
Dan il- livell ta ’ dożaġġ huwa effettiv fit- trattament ta ’ mard kliniku, imma dożaġġi aktar għoljin jew fuq tul ta ’ żmien itwal tat- trattament jistgħu jkunu meħtieġa għall- eliminazzjoni sħiħa ta ’ l- infezzjoni.
It is important to institute medication as early as possible in an outbreak of swine dysentery.
Huwa importanti li tagħti l- mediċina kemm jista ’ jkun kmieni possibbli f’ imxija ta ’ diżenterija tal - majjali.
If there is no response to treatment within 5 days, the diagnosis should be re-established.
Jekk ma jkunx hemm reazzjoni għat- trattament fi żmien 5t ijiem, id- dijanjożi għandha tiġi riveduta.
Indication Treatment of
Indikazzjoni Trattament
Application in feed Incorporation of 75 mg active substance per kg feed with:
Applikazzjoni fl- għalf Inkorporazzjoni ta '75 mg ta' sustanza
Clinical signs of Porcine Proliferative Enteropathy (ileitis)
attiva għal kull kilogramm ta ’ għalf
3-4 mg/ kg bodyweight/ day
korporali/ kulju
2 weeks or until signs of disease disappear
sakemm is- sinjali tal -
Econor 50% - 150 mg / kg feed Econor 10% - 750 mg / kg feed Econor 1% - 7.5 g / kg feed Econor 0.5% - 15 g / kg feed
ma ':
It is important to institute medication as early as possible in an outbreak of porcine proliferative enteropathy.
Sinjali kliniċi ta 'Enterpatija Proliferattiva tal- Majjali (ileitis)
If there is no response to treatment within 5 days, the diagnosis should be re-established.
marda jisparixxu
For severely affected animals which fail to respond to treatment within 3-5 days, parenteral treatment should be considered.
Econor 50% - 150 mg/ kg ta ’ għalf Econor 10% - 750 mg/ kg ta ’ għalf Econor 1% - 7. 5 g/ kg ta ’ għalf Econor 0. 5% - 15 g/ kg ta ’ għalf
4 Indication
4 Dan il- livell ta ’ dożaġġ huwa effettiv taħt sitwazzjoni normali fit- trattament ta ’ sinjali kliniċi ta 'mard, imma dożaġġi aktar għoljin jew fuq tul ta ’ żmien itwal tat- trattament jistgħu jkunu meħtieġa għall - eliminazzjoni sħiħa ta ’ l- infezzjoni.
Prevention of
Indikazzjoni Prevenzjoni ta '
substance)
Dożaġġ (sustanza attiva)
Application in feed Incorporation of 25 mg active substance per kg feed with:
Applikazzjoni fl- għalf Inkorporazzjoni ta '25 mg ta' sustanza attiva għal kull kilogramm ta ’ għalf
minimum of 7 days and
Diżenterija tal - majjali Sinjali kliniċi ta ’ Spirochaetosis kolonika (kolité) tal - majjali
1.0 – 1.5 mg/ kg bodyweight/ day
1. 0 – 1. 5 mg/ kg piż korporali/ kuljum
up to 4 weeks
minimu ta '7t ijiem u sa 4 ġimgħat 4 ġimgħat
4 weeks
ma ':
Econor 10% - 250 mg / kg feed Econor 1% - 2.5 g / kg feed Econor 0.5% - 5 g / kg feed
Econor 50% - 50 mg/ kg ta ’ għalf Econor 10% - 250 mg/ kg ta ’ għalf Econor 1% - 2. 5 g/ kg ta ’ għalf Econor 0. 5% - 5 g/ kg ta ’ għalf
Long term preventative use of valnemulin should be avoided by improving management practice and thorough cleansing and disinfection.
Użu preventiv ta ’ valnemulin fuq tul ta ’ żmien għandu jiġi evitat billi jittejjbu l- prattiċi ta 'ġestjoni u permezz ta ’ tindif u diżinfezzjoni bl- akbar reqqa.
Consideration should be given to the eradication of infection from the farm.
Għandha tingħata konsiderazzjoni għall- qerda ta ’ l - infezzjoni mir- razzett.
Indication Treatment and Prevention of
Indikazzjoni Trattament u Prevenzjoni
Application in feed Incorporation of 200 mg active substance per kg feed with:
Applikazzjoni fl- għalf Inkorporazzjoni ta '200 mg ta' sustanza attiva għal kull kilogramm ta ’ għalf
Swine
ta ’
10 – 12 mg/ kg bodyweight/ day
10 – 12 mg/ kg piż korporali/ kuljum
Up to 3 weeks
Sa tliet ġimgħat
Econor 50% - 400 mg/ kg feed
ma ':
Enzootic Pneumonia
Pnewmonja enżootika tal - majjali
Econor 10% - 2 g/ kg feed
Econor 50% - 400 mg/ kg ta ’ għalf Econor 10% - 2 g/ kg ta ’ għalf
Secondary infection by organisms such as Pasteurella multocida and Actinobacillus pleuropneumoniae may complicate enzootic pneumonia and require specific medication.
Infezzjonijiet sekondarji b’ organiżmi bħal ma huma Pasteurella multocida u Actinobacillus pleuropneumoniae jistgħu jikkumplikaw il- pnewmonja enżootika u jeħtieġu mediċini speċifiċi.
Mixing Instructions:
Struzzjonijiet dwar it- taħlit:
The product has been shown to be stable to the pelleting process at temperatures of 75oC.
Il- prodott ġie muri li huwa stabbli għall- proċess ta ’ pritkunazzjoni f’ temperaturi ta ’ 75oC.
Aggressive pelleting conditions such as temperatures in excess of 80oC, and the use of abrasive substances for pre- mixture should be avoided.
Kundizzjonijiet aggressivi ta ’ pritkunazzjoni bħal temperaturi li jaqbżu t- 80°C, u l- użu ta ’ sustanzi barraxa għat- taħlita lesta minn qabel għandhom jiġu evitati.
Econor 50% mg Econor 50% premix/ kg feed = Dosage required (mg/ kg) x 2 x bodyweight (kg)/ Daily feed intake (kg).
5 Econor 50% mg Econor 50% taħlita lesta minn qabel/ kg ta ’ għalf = Dożaġġ meħtieġ (mg/ kg) x 2 x piż korporali (kg) / teħid ta’ għalf kuljum (kg).
To achieve good mixture and homogeneity of incorporation, the use of pre-mixture is required.
Biex tinkiseb taħlita tajba u omoġeneità fl- inkorporazzjoni, l- użu tat- taħlita lesta minn qabel huwa meħtieġ.
1 part Econor 50% premix to 20 parts feed ingredient.
Il- kwantità tal- prodott meħtieġa hija mħallta tajba ma ’ ingredjent ta 'l- għalf ta ’ natura fiżika simili (e. ż. qmuħ ta ’ kwalità inferjuri) fil- proporzjon: parti 1 Econor 50% taħlita lesta minn qabel ma ’ 20 parti ingredjent ta ’ l- għalf.
Econor 10% mg Econor 10% premix/ kg feed = Dosage required (mg/ kg) x 10 x bodyweight (kg)/ Daily feed intake (kg).
Econor 10% mg Econor 10% taħlita lesta minn qabel/ kg ta ’ għalf = Dożaġġ meħtieġ (mg/ kg) x 10 x piż korporali (kg) / teħid ta’ għalf kuljum (kg).
To achieve good mixture and homogeneity of incorporation, the use of a pre-mixture is recommended.
Biex tinkiseb taħlita tajba u omoġeneità fl- inkorporazzjoni, l- użu tat- taħlita lesta minn qabel huwa rakkomandat.
1 part Econor 10% premix to 10 parts feed ingredient.
Il- kwantità tal- prodott meħtieġa hija mħallta tajba ma ’ ingredjent ta 'l- għalf ta ’ natura fiżika simili (eż. qmuħ ta ’ kwalità inferjuri) fil- proporzjon: parti 1 Econor 10% taħlita lesta minn qabel ma ’ 10 partijiet t’ ingredjent ta ’ l- għalf.
5 Econor 1% mg Econor 1% premix/ kg feed = Dosage required (mg/ kg) x 100 x bodyweight (kg)/ Daily feed intake (kg).
Econor 1% mg Econor 1% taħlita lesta minn qabel/ kg ta ’ għalf = Dożaġġ meħtieġ (mg/ kg) x 100 x piż korporali (kg) / teħid ta’ għalf kuljum (kg).
To achieve good mixture and homogeneity of incorporation, especially when product is incorporated at a rate less than 5 kg/ tonne feed, the use of a pre-mixture is recommended.
Biex tinkiseb taħlita tajba u omoġeneità fl- inkorporazzjoni, speċjalment meta l- prodott hu inkorporat f' rata ta 'inqas minn 5 kg/ tunnellata ta' għalf, l- użu tat- taħlita hu rakkomandat.
The required quantity of product is thoroughly mixed with a feed ingredient of similar physical nature (e. g. wheat middlings) in the proportion:
Il- kwantità tal- prodott meħtieġa hija mħallta tajba ma ’ ingredjent ta 'l- għalf ta ’ natura fiżika simili (eż. qmuħ ta ’ kwalità inferjuri) fil- proporzjon: parti 1 Econor 1% taħlita lesta minn qabel ma ’ 10 parti ingredjent ta ’ l- għalf.
1 part Econor 1% premix to 10 parts feed ingredient.
4. 10 Doża eċċessiva
Econor 0.5% mg Econor 0.5% premix/ kg feed = Dosage required (mg/ kg) x 200 x bodyweight (kg)/ Daily feed intake (kg).
Ma ġewx innotati sinjali tossiċi fuq il- majjali, li ngħataw 5 darbiet id- doża rakkomandata.
4.11 Withdrawal period
4. 11 Perjodu ta 'Tiżmin
1 day
Jum
Antibacterial for systemic use
Antibatteriku għall- użu sistemat Kodiċi vet ATC:
Valnemulin is an antibiotic belonging to the pleuromutilin group, which acts by the inhibition of the initiation of protein synthesis at the level of the bacterial ribosome.
Valnemulin huwa antibijotiku li jappartjeni għall- grupp plewromutlin, li jaġixxi billi jimpedixxi l- bidu tas- sintesi ta 'proteini fil- livell tar- ribosome batteriku.
Valnemulin has activity against a range of bacteria including those responsible for enteric and respiratory disease in pigs.
Valnemulin għandu attività kontra firxa ta 'batterji li jinkludu dawk responsabbli għal mard enteriku u respiratorju fil- majjali.
Valnemulin shows high activity against Mycoplasma spp. and spirochaetes such as Brachyspira hyodysenteriae and Brachyspira pilosicoli.
Valnemulin juri attività għolja kontra Mycoplasma spp. u spirochaetes bħal rachyspira hyodysenteriae u Brachyspira pilosicoli.
Species
6 Specijiet
MIC (Range) (µg/ ml)
MIC (Range) (µg/ ml)
0.0009 – 0.125 0.025 – 4.0 0.0156 – 2.0 < 2.0 is the concentration likely to cause significant inhibition of intracellular growth
0156 – 2. 0 < 2. 0 hija l - konċentrazzjoni li x' aktarx tikkaġuna impediment sinifikanti ta 'tkabbir intraċellulari
0.0025 0.2 0.0156
0156
0.01 1.0 0.5
5
Valnemulin has little activity against Enterobacteriaceae, such as Salmonella spp. and Escherichia coli.
Valnemulin għandu ftit attività kontra Enterobacteriaceae, bħal Salmonella spp. u Escherichia coli.
6 5.2 Pharmacokinetic particulars:
5. 2 Tagħrif Farmakokinetiċi
In pigs, after a single oral dose of radiolabelled material > 90% absorption was demonstrated.
Wara doża orali waħdanija ta ’ materjal radjotikkettat fil- majjali ntwera assorbiment ta ’ > 90%.
Maximum plasma concentrations (Cmax) of radio-labelled or ‘ cold’ material were obtained 1-4 hours after dosing (Tmax) with a plasma half-life (t½), estimated from non-radioactive data, between 1 and 4½ hours.
Konċentrazzjonijiet massimi ta ’ plażma ta ’ materjal radjutikkettat jew ‘ kiesaħ ’ fil- plażma (Cmax) inkisbu siegħa- 4 sigħat wara d- doża (Tmax) b' half life (t½) fil- plażma, li hi stmata minn dejta mhux radjuattiva ta 'bejn siegħa u 4½ sigħat.
A linear relationship between concentration and dose administered was established.
Ġiet stabbilita relazzjoni lineari bejn il- konċentrazzjoni u d - doża mogħtija.
After repeat dosing, slight accumulation occurred, but a steady state was achieved within 5 days.
Wara dożaġġ repetut, seħħet ftit akkumulazzjoni, imma ntlaħaq stat fiss fi żmien 5 t’ ijiem.
Because of a marked ‘ first pass’ effect, plasma concentrations are affected by the method of administration, but valnemulin is highly concentrated in tissues, particularly the lungs and liver, relative to plasma.
Minħabba l- effett ta 'l - ‘ ewwel stadju ’, il- konċentrazzjonijiet fil- plażma huma effettwati mill- metodu ta ’ l- għoti, imma valnemulin huwa kkonċentrat ħafna fit- tessuti, b’ mod partikolari fil- pulmun u fil- fwied, meta mqabbel mal- plażma.
Five days after the last of 15 doses of radiolabelled valnemulin administered to pigs, the concentration in liver was > 6 times that in plasma.
Ħamest ijiem wara l- aħħar minn 15- il doża ta ’ valnemulin radjotikkettat mogħti lill- majjali, il- konċentrazzjoni fil- fwied kienet > 6 darbiet dik fil- plażma.
Two hours after withdrawal of Premix given in feed twice daily for 4 weeks at a dose of 15 mg/ kg bodyweight/ day, liver concentration was 1.58 µg/ g and lung concentration 0.23 µg/ g whereas concentrations in plasma were below the limit of detection.
Sagħtejn wara t- tneħħija ta ’ Premix, mogħti fl- għalf darbtejn kuljum għal 4 ġimgħat f’ doża ta ’ 15 mg/ kg piż korporali/ kuljum, il - konċentrazzjoni fil- fwied kienet ta '1. 58 µg/ g u l- konċentrazzjoni fil- pulmuni kienet ta' 0. 23 µg/ g filwaqt li konċentrazzjonijet fil- plażma kienu taħt il- limitu ta ’ l- osservazzjoni.
In pigs valnemulin is extensively metabolised and excretion of parent molecule and metabolites occurs mainly via bile.
Fil- majjali, valnemulin huwa metabolizzat b’ mod estensiv u r- rimi tal- molekula parenti u l- metaboliti seħħew primarjament mill- bile.
73% - 95% of the daily dose of total radioactivity was recovered from the faeces.
73% - 95% tad- doża ta ’ kuljum tar- radioattività totali ġiet irkuprata mill- ippurgar.
The plasma half-life was 1.3 – 2.7 hours, and the majority of the total radio-activity administered was excreted within 3 days of the last administration.
Il- half life fil- plażma kienet ta ’ bejn 1. 3 – 2. 7 sigħat, u l- maġġoranza tar- radjuattività totali mogħtija kienet eliminata fi żmien 3 ijiem mill- aħħar għoti.
Econor 0.5%, Econor 1%, Econor 10% Hypromellose Talc Colloidal anhydrosus silicum Isopropyl myristate Lactose
Econor 0, 5%, Econor 1%, Econor 10% Hypromellose u talc Colloidal anhydrosus silicum Isopropyl myristate Lactose
Econor 50% Hypromellose Talc
Econor 50% Hypromellose u talc
None known
M' hemm xejn magħruf
6.3 Shelf life
7 6. 3 Żmien ta 'kemm il- prodott idum tajjeb
3 years Econor 50%, Econor 10%, Econor 1%:
3 snin Econor 50%, Econor 10%, Econor 1%:
5 years Shelf-life when incorporated into meal feed and protected from light and moisture:
5 snin Żmien li l- prodott jibqa ’ tajjeb wara li jiġi miżjud ma ’ l- ikel u protett mid- dawl u l- umdità:
3 months Shelf-life when incorporated into pelleted feed and protected from light and moisture:
3 xhur Żmien li l- prodott jibqa ’ tajjeb wara li jiġi pritkunat u protett mid- dawl l- umdità:
3 weeks
3 ġimgħat
Store below 25°C.
Aħżen f' temperaturi inqas minn 25°C.
Store product in the original container.
Aħżen fil- kontenitur oriġinali.
Part-used containers should be tightly closed following dispensing.
Kontenituri li ġew parzjalment użati għandhom jingħalqu sew wara t- teħid minnu.
7 6.5 Nature and composition of immediate packaging
6. 5 In- natura u l- għamla ta ’ l- ewwel ippakkjar
1 x 1 kg and 1 x 25 kg aluminium-lined plastic bags.
1 x 1 kg u 1 x 25 kg boroż tal- plastik inforrati bl- aluminju.
1 x 1 kg, 1 x 2.5 kg and 1 x 25 kg aluminium-lined plastic bags.
Econor 1% 1 x 1 kg, 1 x 2. 5 kg u 1 x 25 kg boroż tal- plastik inforrati bl- aluminju.
1 x 5 kg and 1 x 25 kg aluminium-lined plastic bags.
Econor 0. 5% 5 x 1 kg u 1 x 25 kg pakketti tal- plastik inforrati bl- aluminju.
Novartis Animal Health Austria GmbH Biochemiestrasse 10 A-6250 Kundl Austria + 43 (0)5338 2000
Novartis Animal Health Austria GmbH Biochemiestrasse 10 A- 6250 Kundl L- Awstrija
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI / TIĠDID TAL- AWTORIZZAZZJONI
12 March 1999 / 12 March 2004
12 ta 'Marzu 1999/ 12 ta' Marzu 2004
PROHIBITION OF SALE, SUPPLY AND/ OR USE
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /.
Consideration should be given to official guidance on the incorporation of medicated premixes in final feeds.
Projbizzjoni ta ’ bejgħ, provista, u/ jew użu
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Għandha tingħata kunsiderazzjoni għall- gwida uffiċjali dwar l- inkorporazzjoni ta ’ taħlita medikata ppreparata minn qabel, fl- għalf finali.
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SID/ SIDIEN TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL - LOTT
Usine de Huningue 26, rue de la Chapelle BP 224 68332 Huningue cedex France
Usine de Huningue 26, rue de la Chapelle BP 224 68332 Huningue cedex Franza
Econor 50% Sandoz GmbH Schaftenau Plant A-6336 Langkampfen Austria
Econor 50% Sandoz GmbH Schaftenau Plant A- 6336 Langkampfen L- Awstrija
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L- AWTORIZZAZZJONI TAL - KUMMERĊ FUQ IL- PROVVISTA JEW L- UŻU
Veterinary medicinal product subject to prescription
Prodott mediċinali veterinarju li jingħata bir- riċetta.
Consideration should be given to official guidance on the incorporation of medicated premixes in final feeds.
Għandha tingħata kunsiderazzjoni għall- gwida uffiċjali dwar l- inkorporazzjoni ta ’ taħlita medikata ppreparata minn qabel, fl- għalf finali.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu jinforma lill- Kummissjoni Ewropea dwar il- pjanijiet ta ’ tqegħid fis- suq għall- prodott mediċinali awtorizzat b' din id- deċiżjoni.
C.
11 Ċ.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
PROJBIZZJONI TA ’ BEJGĦ, PROVVISTA, U/ JEW UŻU
The Committee for Veterinary Medicinal Products has recommended the inclusion of valnemulin in Annex I of Council Regulation (EEC) No 2377/ 90 in accordance with the following table:
Il- kumitat tal- Prodotti Veterinarji Mediċi rrakkomanda l- inklużjoni ta 'valnemulin f' Anness I tar - Regolament tal- Kunsill (KEE) Nru 2377/ 90 b' mod konformi mat- tabella li ġejja:
Pharmacologically
Sustanza( i)
MRLs
LRMs
Target tissues
farmakoloġikament
Other
ta 'l -
active substance(s)
Dispożizzjonijiet
residue
attiva( i)
Porcine
Majjali
Kidney Liver Muscle
Kliewi Fwied Muskoli
Annex II of Council Regulation (EEC) No 2377/ 90
Anness II tar- Regolamenti tal- Kunsill (KEE) Nru 2377/ 90
Pharmacologically active substance
Sustanza( i) farmakoloġikament attiva
Animal Species
Speċi ta 'annimal
Other provisions
Dispożizzjonijiet oħra
Hypromellose 2 Purified Talc 3 Colloidal Anhydrous Silicia
Hypromellose 2 Talkum ippurifikat 3 Colloidal Anhydrous Silicia
All food-producing species All food-producing species All food-producing species
L- ispeċi kollha li jipproduċu l- ikel L- ispeċi kollha li jipproduċu l- ikel L- ispeċi kollha li jipproduċu l- ikel
1 OJ No L 320 of 28.11.98 2 OJ No.
1 ĠU Nru L 320 tat- 28. 11. 98 2 ĠU Nru.
L 272 of 25.10.96 3 OJ No.
L 272 tal- 25. 10. 96 3 ĠU Nru.
L 272 of 25.10.96
L 272 tal- 25. 10. 96 12 ANNESS III
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
TIKKETTA
Econor 1% premix for medicated feed for pigs
Econor 1% taħlita mediċinali ta 'l- ikel lesta għall- majjali
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES
DIKJARAZZJONI TAS- SUSTANZA ATTIVA U SUSTANZI OĦRA
Premix for medicated feed
Taħlita lesta għall- għalf mediku
METHOD AND ROUTE OF ADMINISTRATION
METODU U MOD( I) TA 'AMMINISTRAZZJONI
In-feed use
Jingħata ma 'l- ikel.
Read the package leaflet before use
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett
Withdrawal period:
Żmien ta 'Tiżmim:
SPECIAL WARNINGS:
TWISSIJIET SPEĊJALI OĦRA, JEKK MEĦTIEĠ:
Whilst studies in rats and mice have not produced any evidence of teratogenic effect, the safety during pregnancy and lactation has not been established in pigs.
Filwaqt li studji fil- firien u l- ġrieden ma pproduċew l- ebda xhieda ta ’ effett teratoġeniku, is- sigurtà fil - majjali waqt it- tqala u l- irdigħ ma ġietx stabbilita.
When mixing the product and handling the final feed containing the product, direct contact with the skin and mucous membranes should be avoided.
Meta tħallat il- prodott u tkun se tuża l- aħħar għalf li jkun fih il- prodott, għandu jiġi evitat il- kuntatt dirett mal- ġilda u r- riti mukużi.
Adverse drug reactions have occurred following the use of Econor.
Kien hemm reazzjonijiet avversi tal- mediċina wara l- użu ta 'Econor.
Extreme care should therefore be taken in the use of Econor in pigs of Scandinavian origin especially of the Danish and Swedish Landrace breeds, and their crossbreeds thereof.
Għalhekk għandha tingħata attenzjoni kbira fl- użu ta 'Econor fil- majjali ta' oriġini Skandinava speċjalment dawk li ġejjin minn razez ta ’ Danish u Swedish Landrace, u t- taħlitiet tagħhom.
See package leaflet for further information.
Aqra l- fuljett ta 'tagħrif fil- pakkett qabel tuża.
Shelf life:
Żmien ta 'kemm il- prodott idum tajjeb:
Shelf-life when incorporated into meal feed and protected from light and moisture:
Żmien li l- prodott jibqa ’ tajjeb wara li jiġi miżjud ma ’ l- ikel u protett mid- dawl u l- umdità:
Shelf-life when incorporated into pelleted feed and protected from light and moisture:
3 xhur Żmien li l- prodott jibqa ’ tajjeb wara li jiġi pritkunat u protett mid- dawl l- umdità:
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TAL- PRODOTTI MEDIĊINALI VETERINARJI MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
Veterinary medicinal product subject to prescription.
Prodott mediċinali veterinarju li jingħata bir- riċetta.
Novartis Animal Health Austria GmbH Biochemiestraße 10 A-6250 Kundl Austria
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ Novartis Animal Health Austria GmbH Biochemiestraße 10 A- 6250 Kundl L- Awstrija
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[ħalli vojt]
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
17 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
Econor 10% premix for medicated feed for pigs
Econor 10% taħlita mediċinali ta 'l- ikel lesta għall- majjali
At the recommended dosage of 10 – 12 mg/ kg bodyweight, lung lesions and weight loss are reduced, but infection with Mycoplasma hyopneumoniae is not eliminated.
Fid- dożi rakkomandati ta ’ 10 – 12 mg/ kg piż korporali leżjonijet fil- pulmun u telf fil- piż huma mnaqqsa, imma l- infezzjoni b’ Mycoplasma hyopneumoniae mhix eliminata.
SPECIAL WARNING(S):
TWISSIJIET SPEĊJALI:
Extreme care should therefore be taken in the use of Econor in pigs of Scandinavian origin especially of the Danish and Swedish Landrace breeds, and their crossbreeds thereof.
Għalhekk għandha tingħata attenzjoni kbira fl- użu ta 'Econor fil- majjali ta' oriġini Skandinava speċjalment dawk li ġejjin minn razez ta ’ Danish u Swedish Landbrace, u t- taħlitiet tagħhom.
Shelf-life when incorporated into meal feed and protected from light and moisture:
Żmien ta 'kemm il- prodott idum tajjeb wara li jiġi miżjud ma ’ l- ikel u protett mid- dawl u l- umdità:
19 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
20 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
Econor 50% premix for medicated feed for pigs
Econor 50% taħlita mediċinali ta 'l- ikel lesta għall- majjali
In-feed use.
Jingħata ma 'l- ikel.
22 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
23 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
Econor 0.5% premix for medicated feed for pigs
Econor 0. 5% taħlita mediċinali ta 'l- ikel lesta għall- majjali
EU/ 2/ 98/ 010/ 023 (5kg) EU/ 2/ 98/ 010/ 024 (25 kg)
EU/ 2/ 98/ 010/ 023 (5kg) EU/ 2/ 98/ 010/ 024 (25 kg)
26 PACKAGE LEAFLET
FULJETT TA 'TAGĦRIF FIL- PAKKETT
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT
L- ISEM U L- INDIRIZZ TAS- SID TA 'L- AWTORIZZAZZJONI TAT- TQEGĦID FIS - SUQ U S- SID TA' L- AWTOTIZZAZZJONI TAL- MANIFATTURA LI HU RESPONSABBLI MILL- ĦRUĠ TAL- LOTT FIŻ- ŻEE, JEKK DIFFERENTI
Valnemulin hydrochloride
Valnemulin hydrochloride
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA( I) U INGREDJENT( I) OĦRA
Econor 1% premix contains valnemulin in the form of valnemulin hydrochloride.
Econor 1% taħlita lesta fih valnemulin f' għamla ta 'valnemulin hydrochloride.
Valnemulin hydrochloride equivalent to valnemulin base
Valnemulin hydrochloride
10.65 mg/ g 10 mg/ g
10 mg/ g
Hypromellose and talc Colloidal anhydrous silica Isopropyl myristate Lactose
Lista ta ’ sustanzi mhux attivi Hypromellose u talc Colloidal anhydrous silica Isopropyl myristate Lactose
CONTRAINDICATIONS
KONTRADIZZJONIJIET:
A percentage of such pigs may also suffer oedema or erythema (posterior in distribution), and palpebral oedema.
Perċentwal ta ’ dawn il- majjali jista ’ jkollhom ukoll edema u eritima (f’ distribuzzjoni posterjuri), u edema palpebrali.
Mortality was less than 1% but might be increased as a result of secondary infections.
Il- mortalità kienet inqas minn 1%, imma tista ’ tiżdied minħabba infezzjonijiet sekondarji.
Valnemulin is well-accepted in feed, but administered at concentrations above 200 mg/ kg feed may result in transient reduction in food consumption associated with unpalatability during the first few days of feeding.
Valnemulin huwa aċċettat tajjeb fl- għalf, iżda jekk jingħata f’ konċentrazzjonijet akbar minn 200 mg valnemulin/ kg ta ’ għalf, jista ’ jirriżulta fi tnaqqis għaddieni fl- ikkunsmar ta ’ l- ikel assoċjat ma ’ togħma ħażina waqt l- ewwel ftit ġranet tat- tagħlif.
If you notice any other side effects, please inform your veterinary surgeon.
Jekk tinnota xi effetti serji jew effetti oħra mhux msemmija f’ dan il- fuljett, jekk jogħġbok informa lit - tabib veterinarju tiegħek.
DOSAGE, ROUTE AND METHOD OF ADMINISTRATION
DOŻA GĦAL KULL SPEĊJE, MOD( I) U METODU TA 'AMMINISTRAZZJONI
Indication
Indikazzjoni Trattament ta '
(mg active substance/ kg)
Dożaġġ (mg tas - sustanza attiva/ kg)
Application in feed
Il- perijodu t' applikazzjoni ta 'għalf immedikat bħala r- razzjon waħdieni ta' kuljum
Incorporation of 75 mg active
Applikazzjoni fl- għalf Inkorporazzjoni ta '75 mg ta' sustanza
Treatment of
Minimu ta '7 t' ijiem u
substance per kg feed with:
attiva għal kull kilogramm ta ’ għalf
Swine Dysentery
Diżenterija tal- majjali
3-4 mg/ kg bodyweight/ day
korporali/ kulju m
Minimum of 7 days and up to 4 weeks or until signs of disease disappear
sa 4 ġimgħat jew sakemm is- sinjali tal - marda jisparixxu
Econor 1% - 7.5 g/ kg feed
Econor 1% - 7. 5 g/ kg ta ’ għalf
This dose level is effective in the treatment of clinical disease, but higher dosages or longer duration of treatment may be necessary for complete elimination of infection.
29 Dan il- livell ta ’ dożaġġ huwa effettiv fit- trattament ta ’ mard kliniku, imma dożaġġi aktar għoljin jew fuq tul ta ’ żmien itwal tat- trattament jistgħu jkunu meħtieġa għall- eliminazzjoni sħiħa ta ’ l- infezzjoni.
If there is no response to treatment within 5 days, the diagnosis should be re-established.
Jekk ma jkunx hemm reazzjoni għat- trattament fi żmien 5t ijiem, id- dijanjożi għandha tiġi stabbilita mill- ġdid.
28 Indication
Indikazzjoni Trattament tas- sinjali kliniċi
Incorporation of 75 mg active
Applikazzjoni fl- għalf Inkorporazzjoni ta '75 mg ta' sustanza attiva għal kull kilogramm ta ’ għalf ma ':
Treatment of clinical signs
Enteropati
substance per kg feed with:
3- 4 mg/ kg piż korporali/ kuljum
Porcine
Ġimagħtejn jew sakemm is- sinjali tal -
3-4 mg/ kg
Econor 1%
2 weeks or until signs of
- 7. 5 g/ kg ta ’ għalf
Proliferative Enteropathy (ileitis)
Proliferattiva tal- Majjali (ileitis)
disease disappear
marda jisparixxu
This dose level is effective under normal situation in the treatment of clinical signs of disease, but higher dosages or longer duration of treatment may be necessary for complete elimination of infection.
Dan il- livell ta ’ dożaġġ huwa effettiv taħt sitwazzjoni normali fit- trattament ta ’ sinjali kliniċi ta 'mard, imma dożaġġi aktar għoljin jew fuq tul ta ’ żmien itwal tat- trattament jistgħu jkunu meħtieġa għall - eliminazzjoni sħiħa ta ’ l- infezzjoni.
It is important to institute medication as early as possible in an outbreak of porcine proliferative enteropathy.
Huwa importanti li tagħti l- mediċina kemm jista ’ jkun kmieni possibbli f’ tifqigħa ta ’ enteropatija proliferattiva tal- majjali.
If there is no response to treatment within 5 days, the diagnosis should be re-established.
Jekk ma jkunx hemm reazzjoni għat - trattament fi żmien 5t ijiem, id- dijanjożi għandha tiġi stabbilita mill- ġdid.
For severely affected animals which fail to respond to treatment within 3-5 days, parenteral treatment should be considered.
Għall- annimali effettwati serjament li ma jirrispondux għat- trattament fi żmien 3 – 5t ijiem, għandu jiġi kkunsidrat trattament parenterali.
Indication
Indikazzjoni Prevenzjoni ta '
Incorporation of 25 mg active
Applikazzjoni fl- għalf Inkorporazzjoni ta '25 mg ta' sustanza attiva għal kull kilogramm ta ’ għalf
Prevention of
Diżenterij
minimum of 7 days and
minimu ta '7t ijiem u sa 4 ġimgħat
substance per kg feed with:
1. 0 – 1. 5 mg/ kg piż korporali/ kuljum
Econor 1% - 2.5 g/ kg feed
Econor 1% - 2. 5 g/ kg ta ’ għalf
Swine Dysentery Clinical signs of Porcine Colonic Spirochaetosis (colitis)
Sinjali kliniċi ta ’ Spirochaetos is kolonika (kolité) tal - majjali
up to 4 weeks 4 weeks
4 ġimgħat
ADVICE ON CORRECT ADMINISTRATION:
PARIRI SABIEX IL- PRODOTT JINGĦATA KORRETTAMENT:
mg Econor 1% premix/ kg feed = Dosage required (mg/ kg) x 100 x bodyweight (kg)/ Daily feed intake (kg)
mg Econor 1% taħlita lesta minn qabel/ kg ta ’ għalf = Dożaġġ meħtieġ (mg/ kg) x 100 x piż korporali (kg) / teħid ta’ għalf kuljum (kg).
29 To achieve good mixture and homogeneity of incorporation, especially when product is incorporated at a rate less then 5 kg/ tonne feed, the use of a pre-mixture is recommended.
Biex tinkiseb taħlita tajba u omoġeneità fl- inkorporazzjoni, speċjalment meta l- prodott hu inkorporat f' rata ta 'inqas minn 5 kg/ tunnellata ta' għalf, l- użu tat- taħlita hu rakkomandat.
1 part Econor 1% premix to 10 parts feed ingredient.
Il- kwantità tal- prodott meħtieġa hija mħallta tajba ma ’ ingredjent ta 'l- għalf ta ’ natura fiżika simili (eż. qmuħ ta ’ kwalità inferjuri) fil- proporzjon: parti 1 Econor 1% taħlita lesta minn qabel ma ’ 10 parti ingredjent ta ’ l- għalf.
5 years Shelf-life when incorporated into meal feed and protected from light and moisture:
Żmien li l- prodott jibqa ’ tajjeb wara li jiġi miżjud ma ’ l- ikel u protett mid- dawl u l- umdità:
Adverse drug reactions have occurred following the use of Econor.
31 Kien hemm reazzjonijiet avversi tal- mediċina wara l- użu ta 'Econor.
Extreme care should therefore be taken in the use of Econor in pigs of Scandinavian origin especially of the Danish and Swedish Landrace breeds, and their crossbreeds thereof.
Għalhekk għandha tingħata attenzjoni kbira fl - użu ta 'Econor fil- majjali ta' oriġini Skandinava speċjalment dawk li ġejjin minn razez ta ’ Danish u Swedish Landbrace, u t- taħlitiet tagħhom.
Valnemulin is an antibiotic belonging to the pleuromutilin group, which act by the inhibition of the initiation of protein synthesis at the level of the bacterial ribosome.
Valnemulin huwa antibijotiku li jappartjeni għall- grupp plewromutlin, li jaġixxi billi jimpedixxi l- bidu tas- sintesi ta 'proteini fil- livell tar- ribosome batteriku.
31 PACKAGE LEAFLET
32 FULJETT TA 'TAGĦRIF FIL- PAKKETT
Econor 10% premix contains valnemulin in the form of valnemulin hydrochloride.
Econor 10% taħlita lesta fih valnemulin f' għamla ta 'valnemulin hydrochloride.
106.5 mg/ g 100 mg/ g
100 mg/ g
CONTRAINDICATIONS:
KONTRADIZZJONIJIET:
ADVERSE REACTIONS:
EFFETTI MHUX MIXTIEQA
DOSAGE, ROUTE(S) AND METHOD OF ADMINISTRATION
8 DOŻA GĦAL KULL SPEĊJE, MOD( I) U METODU TA 'AMMINISTRAZZJONI
In order to obtain the correct dosage the concentration of Econor has to be adjusted.
It- teħid ta ’ l- għalf immedikat jiddependi fuq il- kundizzjoni klinika ta ’ l- annimal Sabiex jinkiseb id - dożaġġ korrett, il- konċentrazzjoni ta ’ Econor għandha tiġi aġġustata.
Minimum of 7 days and up
Minimu ta '7 t' ijiem u sa
Econor 10% - 750 mg/ kg
attiva għal kull kilogramm ta ’ għalf
to 4 weeks or until signs of disease disappear
4 ġimgħat jew sakemm is- sinjali tal- marda jisparixxu
feed
Econor 10% - 750 mg/ kg ta ’ għalf
33 This dose level is effective in the treatment of clinical disease, but higher dosages or longer duration of treatment may be necessary for complete elimination of infection.
Dan il- livell ta ’ dożaġġ huwa effettiv fit- trattament ta ’ mard kliniku, imma dożaġġi aktar għoljin jew fuq tul ta ’ żmien itwal tat- trattament jistgħu jkunu meħtieġ għall- eliminazzjoni sħiħa ta ’ l- infezzjoni.
Indication
Indikazzjoni Trattament tas - sinjali kliniċi
Treatment of clinical signs
Enteropatija
Econor 10% - 750 mg/ kg
Econor 10% - 750 mg/ kg ta ’ għalf
bodyweight/ day
3- 4 mg/ kg piż korporali/ kulj um
disease disappear
Ġimagħtejn jew sakemm is- sinjali tal - marda jisparixxu
Prevention of
Diżenterija tal- majjali
minimum of 7 days and
1. 0 – 1. 5 mg/ kg piż
substance per kg feed with:
minimu ta '7t ijiem u sa 4 ġimgħat
Econor 10% - 250 mg/ kg
Econor 10% - 250 mg/ kg ta ’ għalf
Swine Dysentery Clinical signs of Porcine Colonic Spirochaetosis (colitis)
Sinjali kliniċi ta ’ Spirochaetosis kolonika (kolité) tal - majjali
1.0 – 1.5 mg/ kg bodyweight/ day
korporali/ kulju m
34 Indication
35 Indikazzjoni Treatment u Prevenzjoni ta '