qanastek/EMEA-V3 huggingface dataset:
Duvaxyn WNV - emulsion for injection for horses
Duvaxyn WNV - emulsjoni għal injezzjoni għaż- żwiemel
Each dose of 1 ml contains:
Kull doża ta ’ 1 ml fiha:
Inactivated West Nile Virus, strain VM-2
Virus West Nile inattivat, razza VM- 2
RP* 1.0- 2.2
RP * 1. 0 - 2. 2
*Relative potency by in vitro method, compared to a reference vaccine that was shown efficacious in horses.
* Qawwa relattiva b’ metodu in vitro, mqabbel ma ’ vaċċin ta ’ referenza li ntwera li kien effikaċi fiż- żwiemel.
Adjuvant:
Sustanza oħra:
MetaStim ™ (SP Oil)
MetaStim™ (Żejt SP)
Emulsion for injection.
Emulsjoni għal injezzjoni
4.1 Target Species
4. 1 Speċi li fuqhom ser jintuża l- prodott
4.2 Indications for use specifying the target species
4. 2 Indikazzjonijiet għal użu tal- prodott li jispeċifikaw l- ispeċi li fuqhom se jintuża l- prodott.
For the active immunisation of horses of 6 months of age or older against West Nile Virus disease by reducing the number of viraemic horses.
Għall- immunizzazzjoni attiva ta ’ żwiemel minn 6 xhur ’ l fuq kontra l- marda kkawżata mill- Virus West Nile billi jitnaqqas n- numru ta ’ żwiemel b’ viremija.
Onset of immunity:
Bidu ta ’ l- immunità:
3 weeks after primary vaccination course.
3 ġimgħat wara l- kors primarju ta ’ vaċċinazzjoni.
Duration of immunity:
Tul ta ’ l- immunità:
12 months after primary vaccination course.
12- il xahar wara l- kors primarju ta ’ vaċċinazzjoni.
4.5 Special precautions for use
2 4. 5 Prekawzjonijiet Speċjali għall- Użu
Only healthy animals should be vaccinated.
Għandhom jiġu vaċċinati annimali b’ saħħithom biss.
2 Vaccination may interfere with existing sero-epidemiological surveys.
Il- vaċċinazzjoni tista ’ tinterferixxi ma ’ studji sero- epidemjoloġiċi eżistenti.
However, since the IgM response following vaccination is infrequent, a positive IgM-ELISA test result is a strong indicator of natural infection with West Nile Virus.
Madankollu, peress li r - rispons tal- IgM wara l- vaċċinazzjoni mhuwiex frekwenti, riżultat pożittiv tat- test IgM- ELISA huwa indikatur qawwi ta ’ infezzjoni naturali bil- Virus West Nile.
If infection is suspected as a result of a positive IgM response, additional testing would need to be conducted to conclusively determine whether the animal was infected or vaccinated.
Jekk hija ssuspettata infezzjoni minħabba rispons IgM pożittiv, ikun meħtieġ li jsiru aktar testijiet biex jiġi determinat b’ mod konklussiv jekk l - annimal kienx infettat jew vaċċinat.
No specific studies have been conducted to demonstrate absence of interferences from maternally derived antibodies on vaccine take.
Ma twettqux studji speċifċi biex jintwera n- nuqqas ta ’ interferenzi minn antikorpi ġejjin mill- omm fuq it- teħid tal- vaċċin.
It is therefore recommended not to vaccinate foals of less than 6 months of age.
Għalhekk huwa rakkomandat li ma jiġi vaċċinat ebda mor ta ’ età inqas minn 6 xhur.
In case of accidental self-injection, ingestion or spillage onto skin, seek medical advice immediately and show the package leaflet or label to the physician.
F' każ li tinjetta lilek innifsek/ li tibilgħu/ li xxerred fuq il- ġilda, fittex parir mediku minnufih u uri l - fuljett ta ’ tagħrif fil- pakkett jew it- tikketta lit- tabib.
A small number of animals may show transient local reactions in the form of a mild, local swelling at the injection site post vaccination (maximum 1 cm in diameter) that resolve spontaneously within 1 to 2 days.
Numru żgħir ta ’ annimali jistgħu juru reazzjonijiet lokali temporanji f’ forma ta ’ nefħa ħafifa fil- lok ta ’ l- injezzjoni wara l- vaċċinazzjoni (dijametru massimu ta ’ 1 cm) li jfiequ spontanjament fi żmien ġurnata sa jumejn.
It is sometimes associated with pain and mild depression.
Dawn xi kultant huma assoċjati ma ’ uġigħ u dipressjoni ħafifa.
In some cases hyperthermia may occur for up to 2 days.
F’ xi każijiet jista ’ jitla ’ d- deni li jdum sa jumejn.
Can be used during pregnancy and lactation.
Jista 'jintuża waqt it- tqala u fi żmien il- ħalib.
No specific efficacy studies were conducted in pregnant mares.
Ma twettqux studji speċifiċi dwar l- effikaċja fi dwieb tqal.
As a consequence, it cannot be excluded that transient immunodepression that may be observed during pregnancy could interfere with vaccine uptake.
Bħala konsegwenza, ma jistax jiġi eskluż li mmunodepressjoni temporanja li tista ’ tkun osservata waqt tqala tista ’ tinterferixxi mat- teħid tal - vaċċin.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
M' hemmx informazzjoni dwar is- sigurtà u l- effikaċja ta ’ dan il- vaċċin jekk jintuża flimkien ma ’ kwalunkwe prodott mediċinali veterinarju ieħor.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Għalhekk id- deċiżjoni li tuża dan il- vaċċin qabel jew wara xi prodott mediċinali veterinarju ieħor għandha ssir skond il- każ.
For intramuscular use.
Għal użu fil- muskoli
Administer one dose (1 ml), by deep intramuscular injection in the neck region, according to the following schedule:
Għati doża waħda (1 ml), permezz ta ’ injezzjoni fonda ġol- muskoli fil- parti ta ’ l- għonq, skond l - iskeda li ġejja:
• Primary vaccination course: first injection from 6 months of age, second injection 3-5 weeks later. • Revaccination: a sufficient degree of protection should be achieved after an annual booster injection with a single dose although this schedule has not been fully validated.
• Kors ta ’ vaċċinazzjoni primarju: l- ewwel injezzjoni minn età ta ’ sitt xhur, it- tieni injezzjoni 3- 5 ġimgħat wara. • Vaċċinazzjoni mill- ġdid: għalkemm din l- iskeda għadha ma ġietx validata kompletament, għandu jintlaħaq grad suffiċjenti ta ’ protezzjoni wara injezzjoni booster ta ’ kull sena b’ doża waħda.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
3 4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti), jekk ikun hemm bżonn
Following the administration of a double dose of vaccine, no adverse reactions other than those described under section 4.6 have been observed.
Wara l- għoti ta ’ doża doppja ta ’ vaċċin, ma kienu osservati l- ebda reazzjonijiet avversi minbarra dawk deskritti taħt sezzjoni 4. 6.
Immunologicals for Equidae – Inactivated viral vaccines - West Nile Virus vaccine
Immunoloġiċi għall- Equidae – Vaċċini virali inattivati - Vaċċin kontra l - Virus West Nile
ATCv code:
Kodici ATĊ veterinarja:
The vaccine stimulates active immunity against West Nile Virus.
Il- vaċċin jistimula immunità attiva kontra l- Virus West Nile.
Minimum Essential Medium (MEM)
Sustanza Essenzjali Minima (MEM)
Do not mix with any other veterinary medicinal product.
Tħallatx ma prodotti mediċinali veterinarji oħra.
Shelf life of the veterinary product as packaged for sale:
Żmien li l- prodott mediċinali veterinarju jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ:
Store and transport refrigerated (2 °C - 8 °C).
Aħżen u ttrasporta ġo friġġ (2°C – 8°C).
Single-dose (1ml) polypropylene syringe closed with latex-free type I rubber tip.
Siringa tal- polipropilin sterili u b’ doża waħda (1 ml) magħluqa b’ tarf tal- gomma tat- tip I mingħajr latex.
Box of 5, 10, or 25 syringes.
Kaxxa ta ’ 5, 10, jew 25 siringa.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements
Mediċina veterinarja li ma ġietx użata jew materjal ta ’ skart li ġej minn dawn il- prodotti mediċinali veterinarji għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
Fort Dodge Animal Health Limited Flanders Road Hedge End Southampton SO30 4QH United Kingdom
Fort Dodge Animal Health Limited Flanders Road Hedge End Southampton SO30 4QH Ir- Renju Unit
MARKETING AUTHORISATION NUMBERS
NUMRI TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
DATE OF THE REVISION OF THE TEXT
DATA TA ’ META ĠIET RIVEDUTA DIN IL- KITBA
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu.
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /.
The import, sale, supply and/ or use of Duvaxyn WNV is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
L- importazzjoni, bejgħ, provista u / jew l- użu ta 'Duvaxyn WNV huwa pprojbit jew jista ’ jkun ipprojbit f' ċertu Stati Membri jew ġo parti mit- Territorju tagħhom minħabba l- politika nazzjonali tagħhom dwar is- saħħa tal- annimali.
Any person intending to import, sell, supply and/ or use Duvaxyn WNV must consult the relevant Member State’ s competent authority on the current vaccination policies prior to the import, sale, supply and/ or use.
Kull persuna li turi l- intenzjoni li timporta, tbiegħ, tipprovdi u/ jew tuża Duvaxyn WNV għandha tikkonsulta ma ’ l- Awtorità Kompetenti ta ’ l- Istat Membru dwar il- programmi ta 'tilqim kurrenti qabel timporta, tbiegħ, tipprovdi u/ jew tuża.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIOLOĠIKA ATTIVA U SID TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL - LOTT
Fort Dodge, Iowa 50501 USA
Fort Dodge, Iowa 50501 L- Istati Uniti
Fort Dodge Laboratories (Ireland) Finisklin Industrial Estate Sligo Ireland
Fort Dodge Laboratories (L- Irlanda) Finisklin Industrial Estate Sligo L- Irlanda
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR IL- PROVISTA U L- UŻU
According to Article 71 of Directive 2001/ 82/ EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/ or use of Duvaxyn WNV on the whole or part of their territory if it is established that:
Skond l- Artikolu 71 tad- Direttiva 2001/ 82/ KEE tal- Parlament Ewropew u tal- Kunsill kif amendat, l - Istati Membri jipprojbixxu jew jistgħu jipprojbixxu l- importazzjoni, il- bejgħ, il- forniment u/ jew l- użu ta ’ Duvaxyn WNV fit- territorju sħiħ tagħhom jew parti minnu jekk jiġi stabbilit illi:
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
a) l- għoti tal- prodott mediċinali veterinarju lill- annimali tinterferixxi ma ’ l- implimentazzjoni ta ’ programmi nazzjonali għad- dijanjosi, il- kontroll u l- eradikazzjoni tal- mard ta ’ l- annimali, jew tikkawża diffikultajiet fiċ- ċertifikazzjoni ta ’ l- assenza tal- kontaminazzjoni f’ annimali ħajjin jew fl- ikel jew prodotti oħrajn akkwistati minn annimali ttrattati
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE OF THE PRODUCT
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV
The following substances contained in the final product are included in Annex II of Council Regulation (EEC) No 2377/ 90 in accordance with the following table:
Is- sustanzi li ġejjin huma inklużi fl- Anness II tar- Regolament tal- Kunsill (EEC) No 2377/ 90 skond it - tabella li ġejja:
Pharmacologically active substances
7 Sustanzi farmakoloġikament attivi
Animal Species
Speċi ta ’ l- annimal
Other provisions
Pluronic L121 (poloxamer)
Pluronic L121 (poloxamer) Annex II for all food Commission Regulation No 2796/ 95 producing species Polysorbate 80 (Polyoxyethylene sorbitan monooleate)
Polysorbate 80 (Polyoxyethylene sorbitan monooleate)
Annex II for all food producing species
Anness II għall- ispeċi kollha li jipproduċu l- ikel
2796/ 95
Regolament tal- Kummissjoni Nru 2796/ 95
Squalane
Squalene
The CVMP considered during its July 2007 meeting that no MRL application would be required for this substance.
Is- KPMV ikkunsidra waqt il- laqgħa tiegħu f’ Lulju 2007 li l- ebda applikazzjoni ta ’ l- MRL ma hija meħtieġa għal din is- sustanza.
Further consideration for the inclusion of the substance in the list of out of scope is ongoing
Aktar kunsiderazzjoni għall- inklużjoni ta ’ din is- sustanza fil- lista sustanzi bla skop għadha għaddejja
8 A.
8 ANNESS III
LABELLING
TIKKETTA U L- FULJETT TA ’ TAGĦRIF FIL- PAKKETT
9 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
TIKKETTA
Box of 5, 10, 25 single-dose polypropylene syringes.
Kaxxa ta ’ 5, 10, 25 siringa tal- polipropilin b’ doża waħda.
Duvaxyn WNV emulsion for injection for horses
DUVAXYN WVN emulsjoni għal injezzjoni għaż- żwiemel
Inactivated West Nile Virus, strain VM-2
Virus West Nile Inattivat, razza VM- 2
*Relative potency by in vitro method, compared to a reference vaccine that was shown efficacious in horses.
* Qawwa relattiva b’ metodu in vitro, mqabbel ma ’ vaċċin ta ’ referenza li ntwera li kien effikaċi fiż - żwiemel.
Emulsion for injection
Emulsjoni għal injezzjoni
1x 5 single-dose syringes.
1x 5 siringi b’ doża waħda.
1x 10 single-dose syringes.
1x 10 siringi b’ doża waħda.
1x 25 single-dose syringes.
1x 25 siringa b’ doża waħda.
For intramuscular use.
Użu għal ġol- muskoli.
EXP {month/ year}
Jiskadi {xahar / sena}
Store and transport refrigerated (2°C – 8°C).
Aħżen u ttrasporta ġo friġġ (2°C – 8°C).
Disposal: read the package leaflet.
Rimi: aqra l- fuljett ta 'tagħrif fil- pakkett.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM "GĦAL TRATTAMENT TA ’ L- ANNIMALI BISS ” U KUNDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVISTA U L- UŻU, jekk applikabbli
To be supplied only on veterinary prescription.
Għal Trattament ta ’ l- Annimali Biss - għandu jingħata biss bi preskrizzjoni veterinarja.
The import, sale, supply and/ or use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory, see package leaflet for further information.
L- importazzjoni, l- bejgħ, il- provista u/ jew l- użu tal- prodott mediċinali veterinarju huwa jew jista ’ jiġi pprojibit f’ ċerti Stati Membri fuq it- territorju kollu tagħhom jew parti minnhom, ara l- fuljett ta ’ tagħrif fil- pakkett għal aktar informazzjoni.
Fort Dodge Animal Health Ltd Flanders Road, Hedge End Southampton SO30 4QH United Kingdom
Fort Dodge Animal Health Ltd Flanders Road, Hedge End Southampton SO30 4QH Ir- Renju Unit
12 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
13 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
Single dose syringe
Siringa b’ doża waħda
Inactivated West Nile Virus, strain VM-2 (RP = 1.0 - 2.2).
KWANTITÀ TAS- SUSTANZA ATTIVA / SUSTANZI ATTIVI
14 Duvaxyn WNV Emulsion for injection For use in horses
FULJETT TA 'TAGĦRIF FIL- PAKKETT
Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton SO30 4QH United Kingdom
Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton SO30 4QH Ir- Renju Unit
Fort Dodge Laboratories Ireland Finisklin Industrial Estate Sligo, Ireland
Fort Dodge Laboratories Ireland Finisklin Industrial Estate Sligo, L- Irlanda
Duvaxyn WNV emulsion for injection for horses
Duvaxyn WNV emulsjoni għal injezzjoni għaż- żwiemel
*Relative potency by in vitro method, compared to a reference vaccine that was shown efficacious in horses.
* Qawwa relattiva b’ metodu in vitro, mqabbel ma ’ fiż- żwiemel.
CONTRAINDICATIONS
16 5 KONTRA INDIKAZZJONIJIET
A small number of animals may show transient local reactions in the form of a mild, local swelling at the injection site post vaccination (maximum 1 cm in diameter) that resolve spontaneously within 1 to 2 days.
Numru żgħir ta ’ annimali jistgħu juru reazzjonijiet lokali temporanji f’ forma ta ’ nefħa ħafifa u lokali fil- lok ta ’ l- injezzjoni wara l- vaċċinazzjoni (dijametru massimu ta ’ 1 cm) li jfiequ spontanjament fi żmien ġurnata sa jumejn.
It is sometimes associated with pain and mild depression.
Dawn xi kultant huma assoċjati ma ’ uġigħ u depressjoni ħafifa.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Jekk tinnota xi effetti serji jew effetti oħra mhux imsemmija f’ dan il- fuljett, jekk jogħġbok informa lit- tabib veterinarju tiegħek.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
8 DOŻA GĦAL KULL SPEĊI, MOD( I) U METODU TA 'AMMINISTRAZZJONI
For intramuscular use.
Użu għal ġol- muskoli
Administer one dose (1 ml), by deep intramuscular injection in the neck region, according to the following schedule:
Għati doża waħda (1 ml), permeż ta ’ injezzjoni fonda ġol- muskoli fil- parti ta ’ l- għonq, skond l- iskeda li ġejja:
Not applicable.
PARIR SABIEX TAMMINISTRA B' MOD KORRETT
Store and transport refrigerated (2°C – 8°C).
Aħżen u ttrasporta fil- friġġ (2°C – 8°C).
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
M' hemmx informazzjoni dwar is- sigurtà u l- effiċjenza ta ’ dan il- vaċċin jekk jintuża flimkien ma ’ kwalunkwe prodott mediċinali veterinarju ieħor.
The use of Duvaxyn WNV reduces the number of animals with viraemia after natural infection, but may not systematically prevent it.
L- użu ta ’ Duvaxyn WNV inaqqas in- numru ta ’ żwiemel b’ viremija wara infezzjoni naturali, iżda jista ’ ma jevitahiex b’ mod sistematiku.
16 Special precautions for use in animals
Prekawzjonijiet speċjali għall- użu fl- annimali
Vaccination may interfere with existing sero-epidemiological surveys.
Il- vaċċinazzjoni tista ’ tinterferi ma ’ studji sero- epidemjoloġiċi eżistenti.
However, since the IgM response following vaccination is infrequent, a positive IgM-ELISA test result is a strong indicator of natural infection with West Nile Virus.
Madankollu, peress li r - rispons tal- IgM wara l- vaċċinazzjoni mhux frekwenti, riżultat pożittiv tat- test IgM- ELISA huwa indikatur qawwi ta ’ infezzjoni naturali bil- Virus West Nile.
The vaccine can be used during pregnancy and lactation.
Il- vaċċin jista 'jintuża waqt it- tqala u fi żmien il- ħalib.
However, no specific efficacy studies were conducted in pregnant mares.
Madankollu, ma twettqux studji speċifiċi dwar l- effikaċja fi dwieb tqal.
As a consequence, it cannot be excluded that transient immunodepression that may be observed during pregnancy could interfere with vaccine uptake.
Bħala konsegwenza, ma jistax jiġi eskluż li mmunodepressjoni temporanja li tista ’ tkun osservata waqt tqala tista ’ tinterferixxi mat- teħid tal- vaċċin.
In case of accidental self-injection, ingestion or spillage onto skin, seek medical advice immediately and show the package leafletor label to the physician.
F' każ li tinjetta lilek innifsek/ li tibilgħu/ li xxerred fuq il- ġilda, fittex parir mediku minnufih u uri l - fuljett ta ’ tagħrif fil- pakkett jew it- tikketta lit- tabib.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Mediċina veterinarja li ma ġietx użata jew materjal ta ’ skart li ġej minn dawn il- prodotti mediċinali veterinarji għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
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 /.
Box of 5 single-dose polypropylene syringes.
Kaxxa ta ’ 5 siringi tal- polypropylene b’ doża waħda.
Box of 10 single-dose polypropylene syringes.
Kaxxa ta ’ 10 siringi tal- polypropylene b’ doża waħda.
Box of 25 single-dose polypropylene syringes.
Kaxxa ta ’ 25 siringa tal- polypropylene b’ doża waħda.
The import, sale, supply and/ or use of Duvaxyn WNV is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
L- importazzjoni, bejgħ, provista u/ jew l- użu ta 'Duvaxyn WNV huwa pprojbit jew jista ’ jkun ipprojbit f' ċertu Stati Membri jew ġo parti mit- territorju tagħhom minħabba l- politika nazzjonali tagħhom dwar is- saħħa tal- annimali.
Any person intending to import, sell, supply and/ or use Duvaxyn WNV must consult the relevant Member State’ s competent authority on the current vaccination policies prior to the import, sale, supply and/ or use.
Kull persuna li turi l- intenzjoni li timporta, tbiegħ, tipprovdi u/ jew tuża Duvaxyn WNV għandha tikkonsulta ma ’ l- awtorità kompetenti ta ’ l- Istat Membru dwar il- programmi ta 'tilqim kurrenti qabel timporta, tbiegħ, tipprovdi u/ jew tuża.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Jekk trid aktar informazzjoni dwar il- kundizzjoni medika jew it- trattament ta ’ l- annimal tiegħek, ikkuntattja lill- veterinarju tiegħek.
What is Easotic?
X' inhu Easotic?
Easotic contains three active substances: hydrocortisone aceponate, miconazole nitrate and gentamicin sulphate.
Easotic fih tliet sustanzi attivi: aċeponat idrokortiżon, mikonażol nitrat u ġentamiċina sulfat.
It is an ear drop suspension for dogs, that is white in colour.
Huwa sospensjoni f’ forma ta ’ qtar tal- widnejn għal klieb li huwa ta ’ kulur abjad.
It is available in a 10 ml bottle.
Huwa disponibbli fi flixkun ta ’ 10 ml.
What is Easotic used for?
Għal xiex jintuża Easotic?
Easotic is used to treat dogs that suffer from acute or recurrent episodes of ear infections (otitis externa).
Easotic jintuża biex jitratta klieb li jsofru minn każijiet akuti jew rikorrenti ta ’ infezzjonijiet fil- widnejn (otite esterna).
It is given once a day for five days.
Jingħata darba kuljum għal ħamest ijiem.
The dose is 1 ml, which is given directly into the ear by one activation of the pump supplied with the bottle.
Id- doża hija ta ’ 1 ml, li tingħata direttament fil- widna b’ attivazzjoni waħda tal- pompa fornuta flimkien mal- flixkun.
The inside of the ear should be cleaned and dried before treatment and any excess hair cut away.
Il- parti ta ’ ġewwa tal- widna għandha titnaddaf u titnixxef qabel it- trattament u jinqata ’ l- pil żejjed.
How does Easotic work?
Kif jaħdem Easotic?
Ear infections in dogs can be caused by bacteria or fungi.
L- infezzjonijiet tal- widnejn fil- klieb jistgħu jiġu kkawżati minn batterji jew fungi.
Two of the active substances in Easotic, miconazole nitrate and gentamicin sulphate, work against the cause of the infection, while the third one, hydrocortisone aceponate, works on the inflammation.
Ta ’ spiss iwasslu sabiex il- widna tkun infjammata (ħamra, minfuħa u tqabbad il- ħakk) Tnejn mis - sustanzi attivi f’ Easotic, mikonażol nitrat u ġentamiċina sulfat jaħdmu kontra l- kawża ta ’ l - infezzjoni, filwaqt li t- tielet wieħed l- idrokortiżon aċeponat jaħdem fuq l- infjammazzjoni.
Hydrocortisone aceponate is a glucocorticosteroid, which is a type of substance that helps to reduce inflammation and itching.
L- aċeponat idrokortiżon huwa glukokortikosterojde li huwa tip ta ’ sustanza li tgħin sabiex titnaqqas l- infjammazzjoni u l- ħakk.
Miconazole nitrate is an antifungal that works by preventing the formation of ergosterol, which is an important part of fungal cell walls.
In- mikonażol nitrat huwa sustanza kontra l- fungi li jaħdem billi jipprevjeni il- formazzjoni ta ’ ergosterol li huwa parti importanti mill- ħitan taċ - ċelloli tal- fungi.
Without ergosterol, the fungus is killed or prevented from spreading.
Mingħajr ergosterol, il- fungu jinqatel jew jinżamm milli jinfirex.
Gentamicin sulphate is an antibiotic that belongs to the group aminoglycosides.
Is - ġentamiċina sulfat huwa antibijotiku li jappartjeni għall- grupp.
It acts by preventing bacteria making proteins.
Dan jaġixxi billi jipprevjeni l - batterji jiffurmaw proteini.
This stops the bacteria growing, resulting in their death.
Dan iwaqqaf il- batterji milli jikbru, li jwassal għal mewt tagħhom.
How has Easotic been studied?
Kif ġie studjat Easotic?
Easotic has been studied in dogs in both laboratory and field trials.
Easotic ġie studjat fi klieb kemm fil- laboratorju kif ukoll fi provi kliniċi fuq il- post.
One large field trial was conducted in different centres throughout Europe.
Sar studju kbir fuq il- post f’ ċentri differenti madwar l- Ewropa.
In the study, the effectiveness of Easotic was compared with that of ear drops containing three similar active substances in dogs with acute or recurrent bacterial or fungal ear infections.
F’ dan l- istudju l- effikaċja ta ’ Easotic tqabbel ma ’ dik tal- qtar tal- widnejn li fih tliet sustanzi attivi fi klieb li jbatu minn infezzjonijiet tal- widnejn akuti jew rikurrenti ta ’ forma batterika jew fungali.
Equal numbers of dogs were assigned to each group, of different breeds, ages, sex and weight.
Ġie assenjat l - istess numru ta ’ klieb għal kull grupp ta ’ razza, età, sess u piż differenti.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Easotic shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged X' benefiċċji wera Easotic tul l- istudji?
When used at the recommended dose for five days, Easotic was as effective as the comparator medicine in improving the symptoms of ear infection (redness, swelling, ear discharge and discomfort).
Meta wżat f’ doża rakkomandata fuq ħamest ijiem, Easotic kien effettiv bħal mediċina ta ’ paragun fit- titjib tas- sintomi ta ’ infezzjonijiet tal- widnejn (ħmura, nefħa, tisfija tal- widna u skomdu).
The medicine was well tolerated.
Il- mediċina ġiet tollerata b’ mod tajjeb.
What is the risk associated with Easotic?
X' inhu r- riskju assoċjat ma 'Easotic?
Mild reddening of the ear has been seen in around 2% of dogs.
Dehret daqxejn ħmura tal- widna f’ madwar 2% tal- klieb.
The use of ear preparations may be associated with damage to hearing.
L- użu ta ’ preparazzjonijiet tal - widnejn jista ’ jiġi assoċjat ma ’ dannu tas- smiegħ.
This is usually temporary and happens primarily in older dogs.
Dan huwa normalment temporanju u jiġri primarjament fi klieb aktar anzjani.
Easotic must not be used in dogs that may be allergic to the active substances or any of the other ingredients, if the eardrum is perforated, at the same time as other medicines that can harm the ear, or in dogs with a parasite infection called generalised demodecosis (mange).
Easotic ma għandux jintuża fi klieb li jistgħu jkunu allerġiċi għas- sustanzi attivi jew għal xi ingredjenti oħrajn, jekk it- tanbur tal- widna jkun mifqugħ, fl- istess waqt bħal mediċini oħrajn li jistgħu ikunu ta ’ dannu għal widna, jew fi klieb li jsofru minn infezzjoni parasittika msejħa demodekożi ġeneralizzata (ġarab).
For a full list of all side-effects reported with Easotic, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrappurtati b' Easotic, ara l- Fuljett ta 'Tagħrif.
If accidental skin or eye contact occurs, wash immediately with lots of water.
Jekk ikun hemm kuntatt aċċidentali mal- ġilda jew ma ’ l- għajnejn, laħlaħ minnufih b’ ħafna ilma.
If a person accidentally takes the medicine or eye irritation occurs, seek medical advice immediately and show the package leaflet or the label to a doctor.
Jekk persuna aċċidentalment tieħu l- mediċina jew ikun hemm irritazzjoni fl- għajnejn, fittex l- għajnuna medika minnufih u uri l- fuljett ta ’ tagħrif jew it- tikketta lil tabib.
Why has Easotic been approved?
Għaliex ġie approvat Easotic?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Easotic exceed the risks for the 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, and recommended that Easotic be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Easotic huma akbar mir- riskji tiegħu għat- trattament ta ’ otite esterna akuta u taħrix akut ta ’ otite esterna rikorrenti fil- klieb assoċjati ma ’ batterji suxxettibbli għal ġentamiċina u fungi suxxettibbli għal mikonażol b’ mod partikolari l- Malassezia pachydermatis u rrakkomanda li Easotic jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Easotic:
Tagħrif ieħor dwar Easotic:
The European Commission granted a marketing authorisation valid throughout the European Union, for Easotic to Virbac S. A. on 20/ 11/ 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea għal Easotic lil Virbac S. A. fit- 20/ 11/ 08.
Information on the prescription status of this product may be found on the label/ outer package.
L- informazzjoni dwar l- istat tal - preskrizzjoni ta ’ dan il- prodott tista ’ tiġi kkonsultata fuq it- tikketta jew fuq il- qoxra tal- pakkett.
This summary was last updated in November 2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
Hydrocortisone aceponate:
Idrokortiżon aċeponat:
1.11 mg/ ml Miconazole (as nitrate form):
1. 11 mg/ ml Mikonażol bħala nitrat:
15.1 mg/ ml Gentamicin (as sulphate form):
15. 1 mg/ ml Ġentamiċin bħala sulfat:
Ear drops, suspension
Suspensjoni tal - Klieb qtar fil- widnejn
Auricular use
Użu awrikulari
Bottle (PP)
Kontenitur multidoża b’ pompa
1 bottle
Kontenitur Ma japplikax 1
Easotic, ear drops suspension, for dogs
Easotic, suspensjoni ta ’ qtar fil- widnejn, għall- klieb
Hydrocortisone aceponate Miconazole as nitrate Gentamicin as sulphate
Idrokortiżon aċeponat Mikonażol bħala nitrat Ġentamiċin bħala sulfat
1.11 mg/ ml 15.1 mg/ ml 1505 IU/ ml
1. 11 mg/ ml 15. 1 mg/ ml 1505 IU/ ml
For a full list of excipients, see section 6.1.
Għal- lista sħiħa ta ’ sustanzi (mhux attivi), ara s- sezzjoni 6. 1.
Ear drops suspension.
Suspensjoni ta ’ qtar fil- widnejn.
A white suspension.
Suspensjoni bajda.
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.
It- trattament 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 għas- sustanza attiva jew kwalunkwe sustanza mhux attiva, għal kortikosterojdi, għal aġenti oħra antifungali ażol u għal aminoglikosidi oħra.
Do not use concurrently with substances known to cause ototoxicity.
Tużax jekk it- tanbur tal- widna hu mtaqqab Tużax flimkien ma ’ sustanzi li huma magħrufa li jikkawżaw ototossiċità.
Do not use in dogs with generalised demodecosis.
Ara sezzjoni 4. 7
Bacterial and fungal otitis is often secondary in nature and appropriate diagnosis should be used to determine the primary factors involved.
Otite batterjali u fungali hi spiss sekondarja fin- natura u għandha tintuża dijanjosi adegwata biex tiddetermina il- fatturi primarji involuti.
If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted.
Jekk ikun hemm sensittività eċċessiva għal kwalunkwe komponiment, il- kura għandha titwaqqaf u tingħata terapija adegwata.
2/ 20 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.
2/ 20 L- użu ta ’ prodott mediċinali veterinarju għandu jkun ibbażat fuq l- identifikazzjoni ta ’ organiżmi li jinfettaw u t- testjar tas- suxxettibilità u jittieħdu nkonsiderazzjoni l- policies antimikrobjali uffiċjali u lokali.
In case of parasitic otitis, an appropriate acaricidal treatment should be implemented.
L- użu ta ’ prodott mediċinali veterinarju li jiddevja mill- istruzzjonijiet mogħtija fl- SPC għandhom mnejn iżidu il- prevalenza ta ’ batterja u fungi li huma reżistenti għal ġentamiċin 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 akariċidali adegwata.
Gentamicin is known to be associated with ototoxicity when administered by the systemic route at higher doses.
Ġentamiċin hi magħrufa li hi assoċjata ma ’ ototossiċità meta tingħata permezz ta ’ mod sistematiku f’ dożi ogħla minn dożi terapewtiċi.
In case of accidental skin contact, it is recommended to wash thoroughly with water.
F ’ 'każ ta ’ kuntatt aċċidentali mal- ġilda, hu rrakkomandat li taħsel sewwa bl- ilma.
Avoid contact with eyes.
Evita kuntatt mal- għajnejn.
In case of accidental contact, rinse with abundant quantities of water.
F’ każ ta ’ kuntatt aċċidentali laħlaħ b’ ħafna ilma.
In case of eye irritation, seek medical advice.
F’ każ ta ’ irritazzjoni tal - għajnejn, fittex tabib.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Jekk tibilgħu b’ mod aċċidentali, fittex tabib mill- ewwel u qis li turih il- fuljett ta 'informazzjoni li jkun fih ġewwa jew it- tikketta.
Mild to moderate redness of the ear was common (2.4% of treated dogs).
Ħmura ħafifa għal moderata tal- widna kienet komuni (2. 4% ta ’ klieb ikkurati).
Papules were observed uncommonly (less than 1% of treated dogs).
Papuli kienu osservati mhux komunement (f’ inqas minn 1% tal- klieb ikkurati).
In all cases, treatment with the veterinary medicinal product was not discontinued and all dogs recovered without any specific therapy.
Fil- każi kollha, il- kura bil- prodott mediċinali veterinarju ma waqfitx u l- klieb kollha rkupraw mingħajr ebda terapija speċifika.
The use of auricular preparations may be associated with hearing impairment, usually temporary, and primarily in geriatric dogs.
L- użu ta ’ preparazzjonijiet awrikulari għandha mnejn tkun assoċjata ma ’ impediment fis- smigħ, ġeneralment temporanju, u primarjament fi klieb xjuħ.
If this occurs, treatment should be stopped.
Jekk dan jiġri il- kura għandha titwaqqaf.
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.
Assorbiment sistematiku ta ’ idrokortiżon aċeponat, ġentamiċin sulfat u mikonażol nitrat kienu negliġibbli, mhux probabbli li jkun hemm ħsara fit- tqala, ħsara lil fetu jew ħsara lil omm bid- dożaġġ rrakkomandat fil- klieb.
Use only accordingly to the risk-benefit assessment by the responsible veterinarian.
Uża biss skond kif il- veterinarju responsabbli iqis il- benefiċċju/ riskju tal- prodott.
Compatibility with ear cleaners has not been demonstrated.
Il- kompattibilità ma ’ prodotti oħra li jnaddfu l- widnejn ma ġietx murija.
Auricular use.
Użu fil- widna.
One ml contains 1.11 mg hydrocortisone aceponate, 15.1 mg miconazole (as nitrate) and 1505 IU gentamicin (as sulphate).
Millilitru fih 1. 11 mg idrokortiżon aċeponat, 15. 1 mg mikonażol (bħala nitrat) u 1505 IU ġentamiċin (bħala sulfat).
It is recommended that the external ear canal should be cleaned and dried before treatment and excess hair around the treatment area be cut.
Huwa rakkomandat li l- kanal estern tal- widna jitnaddaf u jkun ixxuttat qabel it- trattament, u xagħar żejjed madwar fejn se jkun trattat għandu jinqata ’.
Shake the bottle thoroughly before first administration and prime the pump.
Ħawwad il- flixkun sewwa qabel ma tagħti l- ewwel darba, u ara li l- pompa tkun ġibdet.
The recommended dosage is 1 ml of the veterinary medicinal product per infected ear once a day for five consecutive days.
3/ 20 Id- dożaġġ rrakkomandat hu ta ’ 1 ml tal- prodott mediċinali veterinarju f’ kull widna nfettata darba kuljum għal ħamest ijiem konsekuttivi.
3/ 20 Introduce the atraumatic canula in the ear canal.
Daħħal il- kanula atrawmatika fil- kanal tal- widna.
Administer one dose (1 ml) of the product in each affected ear.
Agħti doża waħda (1 ml) tal- prodott f’ kull widna affettwata.
This dose is adequately delivered by one pump activation.
Din id- doża tingħata sewwa b’ attivazzjoni waħda tal- pompa.
The airless pump allows the product to be administered whatever the position of the bottle is.
Il- pompa mingħajr arja tippermetti li jingħata l- prodott hi x’ inhi l- pożizzjoni tal- flixkun.
ins / ear / day for 5 days
Doża waħda / widna / kull ġurnata għal ħamest ijiem ins
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 ikun immassaġġjata għal ftit ħin u b’ mod ġentili biex tħalli l- preparazzjoni tippenetra il- parti t’ isfel tal- kanal tal- widna.
The product as presented allows treating a dog suffering from bilateral otitis.
Il- prodott kif inhu ppreżentat jippermetti l- kura ta ’ kelb li jkun qed ibati minn otite bilaterali.
The veterinary medicinal product should be used at room temperature (i. e. do not instill cold product).
Il - prodott mediċinali veterinarju għandu jintuża f’ temperatura tal- kamra (ie tinstillax prodott kiesaħ).
At 3 and 5 times the recommended dose, no local or general adverse reactions were observed with the exception of some dogs showing erythema and papulae in the ear canal.
Meta d- doża rrakkomandata ngħatat tlett darbiet u ħames darbiet, ma ġiet osservata l- ebda reazzjoni avversa lokali jew ġenerali barra minn xi klieb li wrew eritema u papuli fil- kanal tal- widna.
In dogs treated at the therapeutic dose for ten consecutive days, serum cortisol levels decreased from five days onward and returned to normal values within ten days after the end of treatment.
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.
However, serum cortisol response levels post ACTH stimulation remained in the normal range during the extended treatment period, indicating a preserved adrenal function.
Imma, il- livelli tar- rispons tal- kortiżol fis- serum wara l - istimulazzjoni ACTH baqgħet fil- firxa normali matul il- perijodu estiż tat- trattament, li jindika funzjoni adrenali preżervata.
Pharmacotherapeutic group:
Farmako- terapewtiku:
Otologicals – Corticosteroids and anti-infectives in combination ATCvet code:
Otoloġiku – Kortikosterojdi u sustanzi anti- infettivi flimkien Kodici
QS02CA03
QSO2CA91
5.1 Pharmacodynamic properties
4/ 20 5. 1 Kwalitajiet Farmakodinamiċi
The veterinary medicinal product is a fixed combination of three active substances (corticosteroid, antifungal and antibiotic):
Il- prodott mediċinali veterinarju hu taħlita fissa ta ’ tlett sustanzi attivi (kortikosterojdi, antifungali u antibijotiku):
Hydrocortisone aceponate belongs to the diesters class of the glucocorticosteroids with a potent intrinsic glucocorticoid activity which means a relief of both inflammation and pruritus leading to an improvement of clinical signs observed in otitis externa.
• Idrokortiżon aċeponat jappartjeni għall- klassi dijestri tal- glukokortikojdiċi b’ attività glokokortikojda intrinsika potenti li jfisser serħan minn infjammazzjoni u prurite li jwasslu għal titjib fis- sinjali kliniċi osservati f’ otite esterna.
4/ 20 Miconazole nitrate is a synthetic imidazole derivative with a pronounced antifungal activity.
• Mikonażol (bħala nitrat) hu derivattiv imidażol sintetiku b’ attività pronunzjata antifungali.
Miconazole selectively inhibits the synthesis of ergosterol, which is an essential component of the membrane of yeasts and fungi including Malassezia pachydermatis.
Il - mikonażol jostakola b’ mod selettiv is- sintesi ta ’ ergosterol, li hu komponiment essenzjali tal - membrana tal- ħmira u fungi inklużi Malassezia pakidermatite.
Mechanisms of resistance to azoles consist of either failure in antifungal accumulation or modification of target enzyme.
Il- mekkaniżmi tar- reżistenza għal ażoli jikkonsistu jew f’ falliment fl- akkumulazzjoni antifungali jew modifikazzjoni tal - enżimi tat- targit.
No standardised in-vitro susceptibility breakpoints have been defined for miconazole; however, using the method by Diagnostics Pasteur, no resistant strains were found.
Għal mikonażol, ma ġewx identifikati punti ta’ effikaċja standard, in vitro, ta ’ suxxetibilita; madankollu jekk jintuża l- metodu ta ’ Diagnostics Pasteur, ma nstabu l- ebda strejns reżistenti.
Gentamicin sulphate is an aminoglycoside bactericidal antibiotic which acts by inhibiting protein synthesis.
• Ġentamiċin (bħala sulfat) hu antibijotiku batteriċidali aminoglikosid li jaħdem billi jostakola s- sintesi tal- proteini.
Its spectrum of activity includes Gram-positive and Gram-negative bacteria, such as the following pathogenic organisms isolated from the ears of dogs:
L- ispettru tal- attività jinkludi batterja Gram- pożittiv u Gram- negattiv bħal l- organiżmi patoġeniċi iżolati mill- widnejn tal- klieb:
Staphylococcus intermedius, Streptococcus spp., Pseudomonas aeruginosa, Proteus mirabilis, Escherichia coli, etc… The in-vitro activity of gentamicin against pathogens isolated from clinical cases of canine otitis externa in EU field trials between 2004 and 2007 was:
L- attività in- vitro ta ’ ġentamiċin kontra patoġeni iżolati minn każijiet kliniċi ta ’ otite esterna fil - kliebf’ esperimenti fil- beraħ fl- UE bejn 2004 u 2007 kienu:
Range of MIC (µg/ ml)
Firxa ta ’ MIC (µg/ ml)
Cross-resistance is mainly linked with efflux pumps which confer resistance to β -lactams, quinolones and tetracyclines depending on the specificity of the pump with its substrate.
Bejn 1 u 16
5.2 Pharmacokinetic particulars
MIC- konċentrazzjoni inibitorja minima
After application of the veterinary medicinal product into the ear canal, absorption of miconazole and gentamicin through the skin is negligible.
Peress li ħafna tipi ta ’ batterja għandhom mnejn ikunu involuti f ’ otite esterna fil- klieb, il - mekkaniżmu tar- reżistenza jista ’ jvarja.
Hydrocortisone aceponate belongs to the diesters class of glucocorticosteroids.
Reżistenza inkruċjata hi prinċipalment marbuta ma ’ pompi ta ’ effluss li jagħtu reżistenza kontra β - laktami, kwinoloni u tetraċiklini, jiddependi mill- ispeċifiċità tal- pompa mas- substrat tagħha.
The diesters are lipophilic components ensuring an enhanced penetration into the skin associated with low systemic bioavailability.
Persentaġġi ta ’ batterja reżistenti iżolati minn otite fil- klieb qabel il- kura kontra ġentamiċin (determinati skond il- linji gwida CLSI M31- A2 (≥ 16 µg/ mL) kienu baxxi:
The diesters are transformed inside the skin structures in C17 monoester responsible for the potency of the therapeutic class.
(fost 16- il strejn) rispettivament.
In laboratory animals, hydrocortisone aceponate is eliminated the same way as hydrocortisone (other name for endogenous cortisol) through urine and faeces.
L- ispeċi l- oħra kollha ta ’ batterja (eż Streptococcus spp, Pseudomonas spp, Escherichia coli) kienu totalment suxxettibbli għal ġentamiċin.
5/ 20 6.
5/ 20 Idrokortiżon aċeponat jappartjeni għall- klassi dijesteri ta ’ glukokortikosterojdi.
Liquid paraffin.
Paraffin, Likwidu
Not applicable.
Mhux Applikabbli
10 days.
10 ġranet.
This veterinary medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali veterinarju m’ għandu bżonn ta ’ l- ebda kundizzjoni speċjali sabiex jinħażen.
Multidose container composed of two extruded parts, one external white polypropylene rigid tube and one internal (ethylene-methacrylic acid)-zinc copolymer (Surlyn) flexible pouch containing a steel ball, closed with a 1 ml dosing airless pump equipped with a flexible atraumatic cannula and covered by a plastic cap.
Kontenitur ta ’ multidożi magħmulminn żewġ partijiet li joħorġu ’ l barra, wieħed tubu riġidu abjad estern tal- polipropilin u powċ wieħed flessibbli intern (aċidu etilin- metakriliku) - żingu kopolimer (Surlin) li fih ballun ta ’ l- azzar magħluq b’ pompa mingħajr arja tad- dożaġġ ta ’ 1 ml attrezzat b’ kanula atrawmatika flessibbli u mgħottija b’ kappa tal- plastik.
Box containing 1 multidose container (the content of 10 ml is equivalent to 10 doses).
Kaxxa li fiha kontenitur wieħed ta ’ multidoża (il- kontenut ta ’ 10 ml hu ekwivalenti għal 10 dożi).
06516 Carros FRANCE Tel.
06516 Carros FRANZA Tel.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /
7/ 20 ANNEX II
7/ 20 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
SID TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
06516 Carros FRANCE
06516 Carros FRANZA
To be supplied only on veterinary prescription.
Sabiex jiġi mogħti biss bi preskrizzjoni veterinarja.
9/ 20 ANNEX III
9/ 20 ANNESS III
11/ 20 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
11/ 20 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Easotic, ear drops suspension for dogs Hydrocortisone aceponate - Miconazole – Gentamicin
Easotic, suspensjoni ta ’ qtar fil- widnejn għal klieb Idrokortiżon aċeponat - Mikonażol - Ġentamiċin
Ear drops suspension.
Suspensjoni ta ’ qtar għal widnejn
10 ml (10 doses).
10 ml (10 dożi)
Treatment of acute otitis externa, and acute exacerbation of recurrent otitis externa.
Trattament ta ’ otite akuta esterna, u iggravar ta ’ otite rikurrenti esterna.
METHOD AND ROUTE OF ADMINISTRATION
METODU U MODTA 'AMMINISTRAZZJONI
For auricular use only.
Għal użu fil- widna biss.
Read the package leaflet before use.
Ħawwad il- flixkun sewwa qabel ma tagħti l- ewwel darba u ipprimja l- pompa Qabel l- użu aqra l- fuljett li jinsab fil- pakkett
Read the package leaflet before use.
TWISSIJIET SPEĊJALI OĦRA, JEKK MEĦTIEĠ
EXPIRY DATE
Aqra l- fuljett ta 'tagħrif fil- pakkett qabel tuża.
EXP {month/ year} Once opened use within 10 days.
DATA TA 'SKADENZA
Dispose of waste material in accordance with local requirements.
Armi l- iskart skond il- ħtiġijiet lokali.
Lot {number}
Lott{ numru}
13/ 20 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
13/ 20 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
MULTIDOSE CONTAINER LABEL
TIKKETTA TAL- KONTENITUR TAL- MULTIDOŻI
Easotic, ear drops suspension for dogs Hydrocortisone aceponate - Miconazole – Gentamicin
Easotic, suspensjoni ta’ qtar għal widnejn għall- klieb Idrokortiżon aċeponat - Mikonażol - Ġentamiċin
QUANTITY OF THE ACTIVE SUBSTANCE
KWANTITÀ TAS- SUSTANZA ATTIVA
ROUTE OF ADMINISTRATION
MOD TA ’ AMMINISTRAZZJONI
Auricular use.
Użu fil- widna
EXP {month/ year} Once opened use within 10 days.
Jiskadi {xahar/ sena} Jekk infetaħ uża fi żmien 10 ġranet.
15/ 20 PACKAGE LEAFLET Easotic, ear drops suspension for dogs
15/ 20 FULJETT TA ’ TAGĦRIF FIL- PAKKETT Easotic, suspensjoni ta ’ qtar fil- widnejn għall- klieb
Easotic, ear drops suspension for dogs
Easotic, suspensjoni ta ’ qtar fil- widnejn għall- klieb
STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
DIKJARAZZJONI TAS- SUSTANZI ATTIVI U INGREDJENTI OĦRA
Hydrocortisone aceponate Miconazole as nitrate Gentamicin as sulphate
Idrokortiżon aċeponat Mikonażol bħala nitrat Gentamiċin bħala sulfat