qanastek/EMEA-V3 huggingface dataset:
For the treatment and prevention of porcine respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to doxycycline, when the disease has been diagnosed in the herd.
Għat- trattament u l- prevenzjoni ta ’ marda respiratorja tal- qżieqeż ikkawżata minn Pasteurella multocida u Bordetella bonchiseptica, suxxettibbli għal doxycycline, meta l- marda tkun iddijanjostikata fil- merħla.
Contraindications
Kontra indikazzjonijiet
Do not administer in animals with hypersensitivity to tetracyclines.
Tagħtix lill- annimali b’ sensittività eċċessiva għal tetracyclines.
Do not administer to animals with hepatic damage.
Tagħtix lill- annimali bi ħsara fil- fwied.
The uptake of medicated feed by animals can be altered as a consequence of illness.
It- teħid ta ’ għalf medikat mill- annimali jista ’ jinbidel bħala konsegwenza ta ’ mard.
In case of insufficient feed intake, animals should be treated parenterally.
F’ każ ta ’ teħid insuffiċjenti ta ’ għalf, l- annimali għandhom jiġu ttrattati b’ mod parenterali.
Special precautions for use
Prekawzjonijiet Speċjali għall- Użu
Special precautions for use in animals Due to variability in susceptibility of bacteria for doxycycline, use of the product should be based on bacteriological sampling and sensitivity testing or recent experience on the farm and take into account official and local antimicrobial policies.
Prekawzjonijiet speċjali għall- użu fl- annimali Minħabba l- varjabilità fis- suxxettibbilità tal- batterji għal doxycycline, l- użu tal- prodott għandu jkun ibbażat fuq il- kampjuni batterjoloġiċi u fuq it- testijiet tas- sensittività, jew fuq esperjenza riċenti fir - razzett, u għandhom jiġu kkunsidrati l- policies uffiċjali u lokali kontra l- mikrobi.
Special precautions to be taken by the person administering the veterinary medicinal product to animals Avoid handling the product if hypersensitivity to tetracyclines exists.
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali Evita l- immaniġġjar tal- prodott jekk teżisti sensittività eċċessiva għat- tetracyclines.
10/ 21 Care should be taken to avoid contact with the product during its incorporation to the feed as well as during the administration of the medicated feed to the animals.
10/ 21 Għandha tingħata attenzjoni biex jiġi evitat il- kuntatt mal- prodott meta jiġi miżjud ma ’ l- għalf kif ukoll matul l- għoti ta ’ l- għalf bil- mediċina lill- annimali.
Adequate measures should be taken to avoid powder dissemination during the incorporation of the product to the feed.
Miżuri adegwati għandhom jittieħdu biex jiġi evitat it- tixrid tat- trab meta jiġi miżjud il- prodott ma ’ l - għalf.
It is recommended to use a non-powder mask (according to the EN140FFP1 regulation), gloves, working suit and approved safety glasses.
Hu rakkomandat li tuża maskra mhux tat- trab (skond regolament EN140FFP1), ingwanti, libsa tax - xogħol u nuċċalijiet approvati tas- sigurtà.
Avoid skin and eye contact.
Evita kuntatt mal- ġilda u ma ’ l- għajnejn.
If it occurs, it is recommended to wash the area with plenty of water.
Jekk dan iseħħ, hu rakkomandat li taħsel iż- żona b’ ħafna ilma.
Do not smoke, eat or drink while handling the product.
Tpejjipx, tikolx u l- anqas tixrob meta tkun qed timmaniġġja l- prodott.
If symptoms appear after exposition as a skin eruption, a doctor should be consulted showing these warnings.
Jekk jidhru sintomi wara l- esponiment bħala eruzzjoni tal- ġilda, għandu jiġi kkonsultat tabib u dawn it- twissijiet jintwerewlu.
Inflammation of the face, lips and eyes or respiratory difficulty are more severe signs that require urgent medical attention.
Infjammazzjoni tal- wiċċ, tax- xufftejn u ta ’ l- għajnejn jew diffikultà respiratorja, huma sinjali iktar severi li jeħtieġu attenzjoni medika urġenti.
Adverse reactions (frequency and seriousness)
Effetti mhux mixtieqa (frekwenza u gravità)
Allergic reactions and photosensitivity may appear, as for all tetracyclines.
Reazzjonijiet allerġiċi u s- sensittività għad- dawl jistgħu jidhru, bħalma jiġri bit- tetracyclines kollha.
Digestive alterations by intestinal dysbiosis may appear in very long-term treatments.
Bidliet diġestivi minn disbijosi intestinali għandhom mnejn jidhru f’ trattamenti fuq firxa twila ħafna ta ’ żmien.
Use during pregnancy, lactation or lay
Użu fit- Tqala, fi żmien il- ħalib u meta jbidu l- bajd
The use is not recommended during pregnancy and lactation.
L- użu tiegħu mhux rakkomandat matul it- tqala u jew fi żmien il- ħalib.
Interaction with other medicinal products and other forms of interaction
Effetti fuq prodotti mediċinali oħra jew effetti oħra
Absorption of doxycycline may be diminished in the presence of high quantities of Ca, Fe, Mg or Al in the diet.
L- assorbiment ta ’ doxycycline jista ’ jitnaqqas fil- preżenza ta ’ kwantitajiet għoljin ta ’ Ca, Fe, Mg jew Al fid- dieta.
Do not administer together with antacids, kaolin and iron preparations.
Tagħtix flimkien ma ’ antacids, kaolin u preparazzjonijiet tal- ħadid.
Do not administer in conjunction with bactericidal antibiotics like beta-lactames.
Tagħtix flimkien ma ’ antibijotiċi batteriċidjali, bħal beta- lactames.
Amounts to be administered and administration route
Doża rakkomandata u l- metodu ta ’ amministrazzjoni
In feed use.
Biex jintuża ma ’ l- għalf.
The recommended dose is 10 mg of doxycycline/ kg of body weight/ day (equivalent to 1 g of Doxyprex/ 10 kg of b. w.) for 7 consecutive days.
Id- doża rakkomandata hi ta ’ 10 mg ta ’ doxycycline/ kg ta ’ piż tal- ġisem/ kuljum (ekwivalenti għal 1 g ta ’ Doxyprex/ 10 kg ta ’ p. ġ.) għal 7 ijiem konsekuttivi.
For pigs with a daily consumption of 40 g of feed/ kg b. w. / day this dose corresponds to 250 mg of doxycycline per kg of feed which gives a rate of incorporation of 2.5 kg/ Ton.
Għal qżieqeż li jikkonsmaw kuljum 40 g ta ’ għalf/ kg p. ġ/ kuljum, din id- doża tikkorrispondi għal 250 mg ta ’ doxycycline għal kull kilogramm ta ’ għalf, li tagħti rata ta ’ inkorporazzjoni ta ’ 2. 5 kg/ Tunnellata.
The feed consumption will depend on the clinical condition of the animal.
Il- konsum ta ’ l- għalf ser ikun jiddependi fuq il- kundizzjoni klinika ta ’ l- annimal.
In order to obtain a correct dosage, the concentration of the antimicrobial agent should be adjusted taking into account the daily feed intake at the onset of treatment.
Biex tikseb dożaġġ korrett, il- konċentrazzjoni ta ’ l- aġent kontra l- mikrobi għandu jkun aġġustat billi jiġi kkunsidrat il- konsum ta ’ kuljum ta ’ l- għalf fil- bidu tat - trattament.
The following calculation can be used to calculate dosage:
Il- kalkulazzjoni li ġejja tista ’ tintuża biex tikkalkula d- dożaġġ:
1 mg Doxyprex/ kg feed = 10 mg doxycycline/ kg b. w. x 10 x bodyweight (kg)/ Daily feed intake (kg)
1 mg ta ’ Doxyprex/ kg ta ’ għalf = 10 mg ta ’ doxycycline/ kg p. ġ. x 10 x piż tal- ġisem (kg) / Konsum ta ’ kuljum ta ’ l- għalf (kg)
Mixing instructions:
Struzzjonijiet tat- taħlit:
The premix is only intended to be incorporated into granulated medicated feeding stuffs.
It- taħlita għal- lest hi intenzjonata biss biex tkun miżjuda mal- għalf bil- mediċina li jkun imfarrak.
The following complete feeding stuffs for pigs can be used for the manufacturing of medicated feeds:
L- għalf sħiħ li ġej għal qżieqeż jista ’ jintuża għall- manifattura ta ’ għalf bil- mediċina:
35 kg body weight A horizontal ribbon mixer should be used to incorporate the product into the feeding stuff.
Għalf tal- bidu għal qżieqeż żgħar I (għalf sħiħ sa madwar 20 kg ta ’ piż tal- ġisem) Għalf tal- bidu għal qżieqeż żgħar II (għalf sħiħ sa madwar 35 kg ta ’ piż tal- ġisem) Għalf sħiħ għas- simna tal- qżieqeż sa madwar 50 kg ta ’ piż tal- ġisem 11/ 21 Għalf sħiħ għas- simna tal- qżieqeż ta ’ madwar 50 kg ta ’ piż tal- ġisem Għalf sħiħ għas- simna tal- qżieqeż ta ’ madwar 35 kg ta ’ piż tal- ġisem Ribbon mixer orizzontali għandu jintuża biex iżied il- prodott ġo l- għalf.
It is recommended that one part of Doxyprex is first mixed into one part of the feeding stuff, followed by the rest of the feeding stuff and mixed well.
Hu rakkomandat li parti waħda ta ’ Doxyprex l- ewwel titħallat ma ’ parti waħda ta ’ l- għalf, segwita mill- bqija ta ’ l- għalf, u mbagħad tħallat kollox tajjeb.
Pelleting
L- għalf bil- mediċina jista ’ mbagħad jitfarrak.
11/ 21 conditions involve preconditioning ingredients with steam at 55-65ºC and 10% moisture.
Il- kundizzjonijiet ta ’ l - ikel imnixxef u ppreparat minn qabel jinvolvu li l- ingredjenti jkunu pre- kundizzjonati bil- fwar f’ temperatura ta ’ 55- 65ºC u umdità ta ’ 10%.
Before granulation, flour should not reach a temperature higher than 55 ºC.
Qabel jitfarrak, it- tqiq m’ għandux jilħaq temperatura ogħla minn 55ºC.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti) jekk ikun hemm bżonn
No symptoms of intolerance to the speciality have been detected in the studies conducted in which a medicated feed with 600 ppm (2.4 times the recommended dose) was administered to the 20-30 kg animals during twice the recommended period.
L- ebda sintomi ta ’ intolleranza għall- ispeċjalità ma kienu osservati fl- istudji li saru li fihom l- għalf bil - mediċina b’ 600 ppm (2. 4 darbiet tad- doża rakkomandata) ingħata lill- annimali ta ’ 20- 30 kg matul id - doppju tal- perijodu rakkomandat.
Withdrawal period
Perjodu ta ’ Tiżmim
Meat and offal:
Laħam u l- ġewwieni ta ’ l- annimali:
7 days.
7 ijiem
PHARMACOLOGICAL PROPERTIES
KWALITAJIET FARMAKOLOĠIĊI
Pharmacotherapeutic group:
Grupp Farmako- terapewtiku: veterinarja:
Tetracyclines, ATCvet code:
Antibatterjali għall- użu sistemiku - Tetracyclines, Kodici ATĊ
Pharmacodynamic properties
Kwalitajiet Farmakodinamiċi
Doxycycline is a broad spectrum antibiotic with bacteriostatic activity that acts by interfering on the bacterial protein synthesis of the sensitive species.
Doxycycline hu antibijotiku broad spectrum b’ attività batterjostatika li taġixxi billi tinterferixxi fuq is - sintesi tal- proteini batterjali ta ’ l- ispeċi sensittiva.
Doxycycline is a semi-synthetic tetracycline derived from oxytetracycline that acts on the 30S ribosomal bacterial subunit in a reversible union, by blocking the binding of aminoacyl-tRNA (transference RNA) to the mRNA/ ribosome complex, avoiding the addition of new amino acids to the growing peptide chain and interfering therefore on the protein synthesis.
Doxycycline hu tetracycline semi- sintetiku li jinkiseb minn oxytetracycline li jaġixxi fuq is- sotto- unità batterjali tar- ribosom 30S f’ unjoni riversibbli, billi jimblokka t- twaħħil ta ’ aminoacyl- tRNA (transference RNA) mal- kumpless mRNA/ ribosom, u jevita ż- żieda ta ’ amino acids ġodda mal- katina tal- peptide li tkun qed tikber u għalhekk, jinterferixxi fuq il- proċess tas- sintesi tal- proteina.
It is active against:
Hu attiv kontra:
Pasteurella multocida and Bordetella bronchiseptica
Pasteurella multocida u Bordetella bronchiseptica
“ In Spain during 2001, the in vitro sensitivity to doxycycline has been determined against porcine strains of Pasteurella multocida and Bordetella bronchiseptica resulting in MIC90 values of 0.795µg/ ml and 0.053µg/ ml respectively .”
“ Fi Spanja matul l- 2001, is- sensittività in vitro għal doxycycline kienet stabbilita kontra razez ta ’ batterji tal- qżieqeż ta ’ Pasteurella multocida u Bordetella bronchiseptica li rriżultat f’ valuri MIC90 ta ’ 0. 795 µg/ ml u 0. 053 µg/ ml rispettivament. ”
According to the Clinical and Laboratory Standard (CLSI) regulation, organisms other than streptococci with MIC values ≤ 4 µg/ ml are considered sensitive, at 8 µg/ ml intermediate and with MIC values ≥ 16 resistant to doxycycline.
Skond ir- regolament tal- Clinical and Laboratory Standard Institute (CLSI), organiżmi li mhumiex streptococci b’ valuri MIC ta ’ ≤ 4 µg/ ml huma kkunsidrati li huma sensittivi, f’ valuri intermedji ta ’ 8 µg/ ml, u valuri MIC ta ’ ≥ 16 reżistenti għal doxycycline.
At least two mechanisms of resistance to tetracyclines exist.
Jeżistu mill- inqas żewġ mekkaniżmi ta ’ reżistenza għat- tetracyclines.
The most important mechanism is due to the decrease of the cellular accumulation of the drug.
L- iktar mekkaniżmu importanti hu minħabba it- tnaqqis ta ’ l- akkumulazzjoni ċellulari tal- mediċina.
It is due to the establishment of an elimination route by pumping the antibacterial agent or to an alteration in the transport system, resulting in a limited tetracycline energy-dependent capture to the exterior of the cell.
Dan jiġri minħabba l- ħolqien ta ’ rotta ta ’ l- eliminazzjoni bl- ippumpjar ta ’ sustanza anti- batterika jew minħabba bidla fis- sistema tat - trasport, li tirriżulta fil- qabda ta ’ tetracycline li tiddependi fuq l- enerġija fin- naħa ta ’ barra taċ- ċellula.
Alteration in the transport system is produced by inducible proteins codified in plasmids and transposons.
Il- bidla fis- sistema tat- trasport tiġi prodotta mill- proteini inducible li huma kkodifikati fil- plasmids u transposons.
The other mechanism is evidenced by a reduction in the affinity of the ribosome for the Tetracycline-Mg2+ complex due to mutations in the chromosome.
Il- mekkaniżmu l- ieħor jidher permezz ta ’ tnaqqis fl- affinità tar- ribosom għall- kumpless Tetracycline- Mg2+ minħabba l- mutazzjonijiet fil- kromosoma.
Cross-resistance is frequent between tetracyclines.
Reżistenza inkroċjata hi frekwenti bejn tetracyclines.
Pharmacokinetic particulars
12/ 21 5. 2 Tagħrif Farmakokinetiċi
Absorption after oral and intramuscular administration shows a high bioavailability.
L- assorbiment wara l- għoti mill- ħalq u ġol- muskoli juri bijodisponibilità għolja.
After oral administration, in most species values higher than 70% are reached.
Wara l- għoti mill - ħalq, fil- biċċa l- kbira ta ’ l- ispeċi, jintlaħqu valuri ogħla minn 70%.
Food can slightly modify oral bioavailability of doxycycline.
L- ikel jista ’ jimmodifika xi ftit il- bijodisponibilità orali ta ’ doxycycline.
Doxycycline is widely distributed throughout the organism due to its physico-chemical characteristics, provided that is highly lipid-soluble.
Doxycycline hu ddistribwit ħafna ġo l- organiżmu minħabba l- karatteristiċi fiżiko- kimiċi tiegħu, sakemm ikun jinħall ħafna fil- lipidi.
It reaches well irrigated and peripheral tissues.
Jilħaq tessut li jkun irrigat tajjeb u dak periferali.
Concentrations
Hu kkonċentrat fil- fwied, fil- kliewi, fl- għadam u fl- imsaren; fil- każ ta ’ dan ta ’ l- aħħar, dan jiġri minħabba ċiklu enteroepatiku.
12/ 21 that reaches in lung are always higher than in plasma.
Il- konċentrazzjonijiet li jintlaħqu fil- pulmuni jkunu dejjem ogħla minn dawk fil - plażma.
Therapeutic concentrations have been detected in watery humor, myocardium, reproductive tissues, brain and mammary gland.
Konċentrazzjonijiet terapewtiċi kienu osservati fil- watery humor, fil- mijokardju, fit- tessut riproduttiv, fil- moħħ u u fil- glandola mammarja.
Binding to plasmatic proteins is about 90-92%.
It- twaħħil ma ’ proteini plażmatiċi hu ta ’ madwar 90 - 92%.
A 40% of the drug is metabolised and largely excreted in faeces (bile and intestinal route), mostly as conjugates microbiologically inactive.
40% tal- mediċina ikun metabolat u fil- biċċa l- kbira tiegħu jitneħħa ma ’ l- ippurgar (rotta biljari u intestinali), l- iktar bħala konjugati mikrobijoloġikament inattivi.
Pigs (after weaning) Oral bioavailability of doxycycline ranges between 50-60% values.
Qżieqeż (wara l- ftim) Il- bijodisponibilità orali ta ’ doxycycline tvarja bejn il- valuri ta ’ 50 u 60%.
Once absorbed, the drug is bound in a very high percentage (93%) to plasmatic proteins.
Ġaladarba tkun assorbita, il - mediċina teħel f’ perċentwali għoli ħafna (93%) mal- proteini plażmatiċi.
Provided its lipophilic properties doxycycline is easily distributed in animal tissues, showing volumes of distribution of 0.53 l/ kg.
Minħabba l- proprjetajiet lipofiliċi tiegħu, doxycycline jiġi ddistribwit faċilment fit- tessut ta ’ l- annimal, u juri volumi tad- distribuzzjoni ta ’ 0. 53 l/ kg.
Its hepatic metabolism is scarce, showing traces of some metabolites at kidney level.
Il- metaboliżmu tiegħu fil- fwied hu baxx, u juri traċċi ta ’ xi metaboliti fil- livell tal- kliewi.
Its excretion is carried out through the intestinal mucous and in a lower extent, through bile excretion, resulting in plasmatic clearance values of 1.7 ml/ min/ kg.
It- tneħħija tiegħu ssir permezz tal- mukuża intestinali, u fi grad iktar baxx, permezz tat- tneħħija minn ġol- bila, li tirriżulta f’ valuri tat- tneħħija plażmatika ta ’ 1. 7 ml/ min/ kg.
Following single dose administration, Cmax was 1.70 µg/ ml with a Tmax of 6 hours.
Wara l- għoti ta ’ doża waħda, is- Cmax kienet ta ’ 1. 70 µg/ ml b’ Tmax ta ’ 6 sigħat.
Administration of the product according to the recommended posology results in a maximum plasmatic concentration at steady of 2.0 ± 0.4 µg/ ml.
L- għoti tal- prodott skond il- pożoloġija rakkomandata tirriżultata f’ konċentrazzjoni plażmatika massima fl- istat fiss ta ’ 2. 0 ±0. 4 µg/ ml.
After withdrawal of medication, half-life of the terminal phase is of 6 h.
Wara li l- mediċina titwaqqaf, il- half- life tal- fażi terminali hi ta ’ 6 sigħat.
It is mainly eliminated through the small intestine that supposes an advantage in relation to the rest of tetracyclines provided that it is not accumulated in the organism when renal function is diminished since it is not its mainly route of elimination.
Hi primarjament eliminata minn ġol- musrana ż- żgħira, u hu maħsub li dan hu ta ’ vantaġġ fir- rigward tal- bqija tat - tetracyclines, sakemm ma tkunx akkumulata fl- organiżmu meta l- funzjoni tal- kliewi tonqos, għax din mhijiex ir- rotta ewlenija ta ’ l- eliminazzjoni.
List of excipients
Lista ta ’ ingredjenti
Liquid sorbitol, non-crystallising Liquid paraffin Semolinea (declared on labelling as carrier)
Liquid sorbitol, non- crystallising Liquid paraffin Semolinea (iddikjarata fuq it- tikketta bħala carrier)
Do not administer with oxidant substances.
Tagħtix ma sustanzi ossidanti.
Shelf life
Żmien ta ’ kemm il- prodott idum tajjeb
Shelf-life of the veterinary medicinal product as packaged for sale:
Żmien li l- prodott mediċinali veterinarju jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ:
Shelf-life after first opening the immediate packaging:
Żmien li l- prodott jibqa ’ tajjeb wara li jkun tneħħa mill- ewwel ippakkjar:
Shelf-life after incorporation into pelleted feed:
Żmien li l- prodott jibqa ’ tajjeb wara li jiġi miżjud ma ’ l- ikel imnixxef u ppreparat minn qabel:
After first opening, keep the pack tightly closed.
Wara li jinfetaħ għall- ewwel darba, żomm il- pakkett magħluq tajjeb.
Store in a dry place.
Aħżen f’ post xott.
Special precautions for storage
6. 4 Tagħrif speċjali dwar kif għandu jinħażen
Store below 30 ºC.
Aħżen f’ temperaturi anqas minn 30 ºC.
6.5.
13/ 21 6. 5.
Nature and composition of immediate packaging
In- natura u l- għamla ta ’ l- ewwel ippakkjar
Containers of 1 kg, 5 kg, 20 kg and 25 kg.
Kontenituri ta ’ 1 kg, 5 kg, 20 kg u 25 kg.
Thermosealed bags of a complex film made of polyester external layer, aluminium intermediate layer and polyethylene internal layer that is in contact with the product.
Boroż thermosealed ta ’ rita kumplessa magħmula minn saff estern tal- polyester, saff intermedju ta ’ l - aluminju u saff intern tal- polyethylene li jmiss mal- prodott.
In the 5 kg, 20 kg and 25 kg presentations, bags contain an additional intermediate nylon layer.
Fil- preżentazzjonijiet tal- 5 kg, 20 kg u 25 kg, il- boroż fihom saff addizzjonali intermedju tan- nylon.
The closure is by thermosealing.
L- għeluq hu permezz ta ’ thermosealing.
Not all pack sizes may be marketed
Mhux id- daqsijiet kollha tal- pakketti jistgħu jitpoġġew fis- suq
Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użata jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
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 prodotti oħra li ntużaw għal din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
MARKETING AUTHORISATION HOLDER
L- ENTITÀ LI GĦANDHA L- AWTORIZZAZZJONI TAL- KUMMERĊ
Esmeralda, 19 E-08950 Esplugues de Llobregat (Barcelona) Spain Tel: +34 934 706 270 Fax: +34 933 727 556 e-mail: invesa@invesagroup. com
Esmeralda, 19 E- 08950 Esplugues de Llobregat (Barċelona) Spanja Tel: +34 934 706 270 Fax: +34 933 727 556 e- mail: invesa@ invesagroup. com
MARKETING AUTHORISATION NUMBER(S)/ MRP PROCEDURE NUMBER
L- AWTORIZZAZZJONI
04/ 02/ 2004
04/ 02/ 04
{< DD/MM/YYYY >}
{< JJ/ XX/ SSSS >}
PROHIBITION OF SALE, SUPPLY AND/ OR USE
PROJBIZZJONI TA ’ BEJGĦ, PROVVISTA, U/ JEW UŻU
14/ 21 LABELLING AND PACKAGE INSERT
14/ 21 TIKKETTA U L- FULJETT TA ’ TAGĦRIF FIL- PAKKETT
15/ 21 PACKAGE LEAFLET
15/ 21 FULJETT TA ’ TAGĦRIF FIL- PAKKETT
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH REALISE, IF DIFFERENT
L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ, U L - ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L- KONSENJA TMUR FIS- SUQ, JEKK DIFFERENTI
Esmeralda, 19 E-08950 Esplugues de Llobregat (Barcelona) Spain
Esmeralda, 19 E- 08950 Esplugues de Llobregat (Barċelona) Spanja
Doxyprex 100 mg/ g Premix
Doxyprex 100 mg/ g taħlita għal- lest
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA( I) U INGREDJENT( I) OĦRA
Doxyprex is presented as yellow granules containing 100 mg of doxycycline base as hyclate per gram of product.
Doxyprex hu fornut fi granuli sofor li fihom 100 mg ta ’ bażi ta ’ doxycycline bħala hyclate f’ kull gramma ta ’ prodott.
Semoline is employed as carrier.
Semoline jintuża bħala carrier.
INDICATION(S)
INDIKAZZJONI( JIET)
CONTRAINDICATIONS
KUNTRADIZZJONIJIET
ADVERSE REACTIONS
EFFETTI MHUX MIXTIEQA
If you notice any serious effects or other effects not mentioned in this label, 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.
TARGET SPECIES
SPEĊJI LI GĦALIHOM HUWA INDIKAT IL- PRODOTT
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
DOŻA GĦAL KULL SPEĊJE, MOD( I) U METODU TA ’ AMMINISTRAZZJONI
For pigs with a daily consumption of 40 g of feed/ kg
16/ 21 Id- doża rakkomandata hi ta ’ 10 mg ta ’ doxycycline/ kg ta ’ piż tal- ġisem/ kuljum (ekwivalenti għal 1 g ta ’ Doxyprex/ 10 kg ta ’ p. ġ.) għal 7 ijiem konsekuttivi.
16/ 21 b. w. / day this dose corresponds to 250 mg of doxycycline per kg of feed which gives a rate of incorporation of 2.5 kg/ Ton..
Għal qżieqeż li jikkonsmaw kuljum 40 g ta ’ għalf/ kg p. ġ/ kuljum, din id- doża tikkorrispondi għal 250 mg ta ’ doxycycline għal kull kilogramm ta ’ għalf, li tagħti rata ta ’ inkorporazzjoni ta ’ 2. 5 kg/ Tunnellata.
In order to obtain a correct dosage, the concentration of the antimicrobial agent should be adjusted taking into account the daily feed intake at the onset of treatment.
Biex tikseb dożaġġ korrett, il- konċentrazzjoni ta ’ l- aġent kontra l- mikrobi għandu jkun aġġustat billi jiġi kkunsidrat il - konsum ta ’ kuljum ta ’ l- għalf fil- bidu tat- trattament.
ADVICE ON CORRECT ADMINISTRATION
PARIR SABIEX TAMMINISTRA B’ MOD KORRETT
20 kg body weight) Piglet starter feed II (complete feed up to approx.
Għalf tal- bidu għal qżieqeż żgħar I (għalf sħiħ sa madwar 20 kg ta ’ piż tal- ġisem) Għalf tal- bidu għal qżieqeż żgħar II (għalf sħiħ sa madwar 35 kg ta ’ piż tal- ġisem) Għalf sħiħ għas- simna tal- qżieqeż sa madwar 50 kg ta ’ piż tal- ġisem Għalf sħiħ għas- simna tal- qżieqeż ta ’ madwar 50 kg ta ’ piż tal- ġisem Għalf sħiħ għas- simna tal- qżieqeż ta ’ madwar 35 kg ta ’ piż tal- ġisem Ribbon mixer orizzontali għandu jintuża biex iżied il- prodott ġo l- għalf.
50 kg body weight Complete feed for fattening pigs of approx.
Hu rakkomandat li parti waħda ta ’ Doxyprex l- ewwel titħallat ma ’ parti waħda ta ’ l- għalf, segwita mill- bqija ta ’ l- għalf, u mbagħad tħallat kollox tajjeb.
50 kg body weight Complete feed for fattening pigs of approx.
L- għalf bil- mediċina jista ’ mbagħad jitfarrak.
35 kg body weight A horizontal ribbon mixer should be used to incorporate the product into the feeding stuff.
Il- kundizzjonijiet ta ’ l - ikel imnixxef u ppreparat minn qabel jinvolvu li l- ingredjenti jkunu pre- kundizzjonati bil- fwar f’ temperatura ta ’ 55- 65ºC u umdità ta ’ 10%.
It is recommended that one part of Doxyprex is first mixed into one part of the feeding stuff, followed by the rest of the feeding stuff and mixed well.
Qabel jitfarrak, it- tqiq m’ għandux jilħaq temperatura ogħla minn 55ºC.
WITHDRAWAL PERIOD
PERJODU TA ’ TIŻMIM
SPECIAL STORAGE PRECAUTIONS
PREKAWZJONIJIET SPEĊJALI GĦALL- ĦAŻNA
EXP {month/ year} Do not use after the expiry date.
JIS {xahar/ sena} Tużax wara d- data tal- iskadenza.
Shelf-life after first opening the immediate packaging:
Iż- żmien kemm idum tajjeb il- prodott wara li jinfetaħ l- ewwel pakkett għall- ewwel darba:
Shelf-life after incorporation into pelleted feed:
Iż- żmien ta ’ kemm idum tajjeb wara li jiġi miżjud ġo għalf imnixxef u ppreparat minn qabel:
SPECIAL WARNING(S)
TWISSIJIET SPEĊJALI
Due to variability in susceptibility of bacteria for doxycycline, use of the product should be based on bacteriological sampling and sensitivity testing or recent experience on the farm and take into account official and local antimicrobial policies.
Minħabba l- varjabilità fis- suxxettibbilità tal- batterji għal doxycycline, l- użu tal- prodott għandu jkun ibbażat fuq il- kampjuni batterjoloġiċi u fuq it- testijiet tas- sensittività, jew fuq esperjenza riċenti fir - razzett, u għandhom jiġu kkunsidrati l- policies uffiċjali u lokali kontra l- mikrobi.
Absorption of doxycycline may be diminished in the presence of high quantities of Ca, Fe, Mg or Al in the diet.
17/ 21 L- assorbiment ta ’ doxycycline jista ’ jitnaqqas fil- preżenza ta ’ kwantitajiet għolja ta ’ Ca, Fe, Mg jew Al fid- dieta.
Do not administer together with antacids, kaolin and iron preparations.
Tagħtihx flimkien ma ’ antacids, kaolin u preparazzjonijiet tal- ħadid.
Do not administer with oxidant substances.
Tagħtix ma sustanzi li jossidaw.
17/ 21 The uptake of medicated feed by animals can be altered as a consequence of illness.
It- teħid ta ’ għalf medikat mill- annimali jista ’ jinbidel bħala konsegwenza ta ’ mard.
Avoid handling the product if hypersensitivity to tetracyclines exists.
Evita l- immaniġġjar tal- prodott jekk teżisti sensittività eċċessiva għat- tetracyclines.
Care should be taken to avoid contact with the product during its incorporation to the feed as well as during the administration of the medicated feed to the animals.
Għandha tingħata attenzjoni biex jiġi evitat il- kuntatt mal- prodott meta jiġi miżjud ma ’ l- għalf kif ukoll matul l- għoti ta ’ l- għalf bil- mediċina lill- annimali.
Inflammation of the face, lips and eyes or respiratory difficulty are more severe signs that require urgent medical attention It is not recommended its use in pregnant animals and during lactation periods.
Mhux rakkomandat l- użu tiegħu f’ annimali tqal u matul il- perijodju tat- treddigħ.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA ’ PRODOTT MHUX UŻATA JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Prodotti mediċinali veterinarji jew skart minn dan il- prodott mediċinali veterinarju li ma ġewx użati għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
DATA META ĠIE APPROVAT L- AĦĦAR IL- FULJETT INFORMATTIV FIL - PAKKETT
OTHER INFORMATION
TAGĦRIF IEĦOR
To be supplied only on veterinary prescription
Sabiex jingħata biss bi preskrizzjoni veterinarja.
PACKAGE SIZE 1 kg 5 kg 20 kg 25 kg
DAQS TAL- PAKKETT 1 kg 5 kg 20 kg 25 kg
18/ 21 PARTICULARS TO APPEAR ON THE OUTER PACKAGE PARTICULARS TO APPEAR ONTHE IMMEDIATE PACKAGE
18/ 21 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
Doxyprex 100 mg/ g Premix
Doxyprex 100 mg/ g Taħlita għall- lest
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
DIKJARAZZJONI TAS- SUSTANZA ATTIVA U SUSTANZI OĦRA
Premix for medicated feeding stuff
Ikel imħallat mal- mediċina għal- lest
PACKAGE SIZE
DAQS TAL- PAKKETT
TARGET SPECIES
SPEĊI GĦAL X’ HIEX HUWA INDIKAT IL- PRODOTT
For the treatment and prevention of porcine respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to doxycycline, when the disease has been diagnosed in the herd.
Għat- trattament u l- prevenzjoni ta ’ marda respiratorja tal- qżieqeż ikkawżata minn Pasteurella multocida u Bordetella bronchiseptica, suxxettibbli għal doxycycline, meta l- marda tkun iddijanjostikata fil- merħla.
METHOD AND ROUTE(S) OF ADMINISTRATION
METODU U MOD( I) TA ’ AMMINISTRAZZJONI
In feed use
Biex jintuża ma ’ l- għalf.
WITHDRAWAL PERIOD
ŻMIEN TA ’ TIŻMIM
SPECIAL WARNING(S), IF NECESSARY
TWISSIJIET SPEĊJALI OĦRA, JEKK MEĦTIEĠ
Due to variability in susceptibility of bacteria for doxycycline, use of the product should be based on bacteriological sampling and sensitivity testing or recent experience on the farm and take into account official and local antimicrobial policies.
Minħabba l- varjabbilità fis- suxxettibbilità tal- batterji għal doxycycline, l- użu tal- prodott għandu jkun ibbażat fuq il- kampjuni batterjoloġiċi u fuq it- testijiet tas- sensittività, jew fuq esperjenza riċenti fir - razzett, u għandhom jiġu kkunsidrati l- policies uffiċjali u lokali kontra l- mikrobi.
Do not administer with oxidant substances.
Tagħtix ma ’ sustanzi li jossidaw.
Do not smoke, eat or drink while handling the product.
Tpejjipx, tikolx u tixrobx meta tkun qed timmaniġġja l- prodott.
Adequate measures should be taken to avoid powder dissemination during the incorporation of the product to the feed.
Miżuri adegwati għandhom jittieħdu biex jiġi evitat it- tixrid tat- trab meta l- prodott jiġi miżjud mal - għalf.
Inflammation of the face, lips and eyes or respiratory difficulty are more severe signs that require urgent medical attention It is not recommended its use in pregnant animals and during lactation periods.
Mhux rakkomandat l- użu tiegħu f’ annimali tqal u matul il- perijodi tat- treddigħ.
SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET SPEĊJALI DWAR KIF GĦANDU JINĦAŻEN
EXP {month/ year} Do not use after the expiry date.
JIS {xahar/ sena} Tużax wara d- data ta ’ l- iskadenza.
Shelf-life after incorporation into pelleted feed:
Żmien li l- prodott jibqa ’ tajjeb wara li jiġi miżjud ma ’ ikel imnixxef u ppreparat minn qabel:
SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA ’ PRODOTTI MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Kwalunkwe prodott mediċinali veterinarju jew skart prodott minn dan il- prodott mediċinali veterinarju għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
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 KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVISTA U L- UŻU, jekk applikabbli
THE WORDS “ KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
IL- KLIEM “ ŻOMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL ”
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
L- ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
London, June 2008 EMEA/ 532206/ 2007- Rev.1
Londra, Ġunju 2008 EMEA/ 532206/ 2007 - Rev. 1
OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR DOXYPREX 100mg PREMIX
OPINJONI WARA REFERENZA SKOND L- ARTIKOLU 33 (4) GĦAL DOXYPREX 100mg PREMIX
Doxyprex 100 mg premix presented in 5 kg, 20 kg and 25 kg bags containing 100 mg/ g doxycycline base as hyclate.
Doxyprex 100 mg premix ippreżentat f’ boroż ta ’ 5 kg, 20 kg u 25 kg li fihom 100 mg/ g ta ’ bażi ta ’ doxycycline bħala hyclate.
The product is authorised with the indication the treatment of swine respiratory disease caused by Pasteurella multocida, Bordetella bronchiseptica and Mycoplasma hyopneumoniae.
Il- prodott huwa awtorizzat bl- indikazzjoni tat- trattament tal- marda respiratorja fil- majjali kkawżata minn Pasteurella multocida, Bordetella bronchiseptica u Mycoplasma hyopneumoniae.
In December 2005, a Mutual Recognition Procedure (MRP) started with Spain acting as Reference Member State and ten Concerned Member States.
F’ Diċembru 2005, inbdiet Proċedura ta ’ Rikonoxximent Reċiproku (MRP) ma ’ Spanja bħala Stat Membru ta ’ Referenza u għaxar Stati Membri Konċernati.
Germany could not agree to the granting a marketing authorisation and the matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures, CMD(v), and subsequently to the Committee for Medicinal Products for Veterinary Use (CVMP).
Il- Ġermanja ma setgħetx taqbel ma ’ l- għoti ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- kwistjoni ġiet riferuta lill- Grupp ta ’ Koordinament għal Proċeduri ta ’ Rikonoxximent Reċiproku u Deċentralizzati, CMD( v), u suċċessivament lill- Kumitat għal Prodotti Mediċinali għall- Użu Veterinarju (CVMP).
Germany considered that the product could represent a potential serious risk to animal health on the grounds that the efficacy had not been sufficiently substantiated.
Il- Ġermanja ħasset li l- prodott seta ’ jirrappreżenta riskju potenzjali serju għas- saħħa ta ’ l- annimali fuq il- bażi li l- effikaċja ma kinitx ġiet sostanzjata b’ mod suffiċjenti.
The CVMP during its meeting of 21-22 June 2006 started a referral procedure under Article 33(4) of Directive 2001/ 82/ EC, as amended, for Doxyprex 100 mg premix.
Waqt il- laqgħa tiegħu tal- 21- 22 ta ’ Ġunju 2006, is- CVMP beda proċedura ta ’ referenza taħt l- Artikolu 33( 4) tad- Direttiva 2001/ 82/ KE, kif emendata, għal Doxyprex 100 mg premix.
The Marketing Authorisation Holder (MAH) was requested to substantiate the efficacy of the product.
Id- Detentur ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq (MAH) ġie mitlub jissostanzja l- effikaċja tal- prodott.
The applicant provided a justification for submission of this application on a “ well-established use” basis.
L- applikant ipprovda ġustifikazzjoni għas- sottomissjoni ta ’ din l- applikazzjoni fuq bażi ta ’ “ użu stabbilit sewwa ”.
Within the EU doxycycline-based premix products for pigs at recommended dose rates of 10mg/ kg once daily for 5 days are stated as having been authorised since 1985.
Fi ħdan l- UE, il- prodotti premix ibbażati fuq doxycycline għall- majjali b’ rati rakkomandati ta ’ doża ta ’ 10mg/ kg darba kuljum għal 5 ijiem huma ddikjarati li ilhom awtorizzati sa mill- 1985.
Annex I of Directive 2001/ 82/ EC as amended by directive 2004/ 28/ EC notes that post-marketing experience with other products containing the same constituents is of particular importance and applicants should put a special emphasis on this issue.
L - Anness I tad- Direttiva 2001/ 82/ KE kif emendat bid- Direttiva 2004/ 28/ KE jinnota li l- esperjenza ta ’ wara t- tqegħid fis- suq ta ’ prodotti oħra li fihom l- istess kostitwenti hija ta ’ importanza partikolari u l - applikanti għandhom jagħmlu enfasi speċjali fuq din il- kwistjoni.
Therefore, the CVMP considered that the reports mentioned above give favourable evidence for the safety and efficacy of doxycycline in general, but also for the specific final formulation as marketed in Spain.
Għalhekk, is- CVMP ħass li r - rapporti msemmija hawn fuq jagħtu evidenza favorevoli għas- sigurtà u l- effikaċja ta ’ doxycycline b’ mod ġenerali, iżda wkoll għall- formulazzjoni finali speċifika kif imqiegħda fis- suq fi Spanja.
The applicant submitted a scientific report on Porcine Respiratory Disease Complex (PRDC).
L- applikant ippreżenta rapport xjentifiku dwar il- Kumpless tal- Marda Respiratorja tal- Majjali (PRDC).
In the pivotal clinical trial, the presence of P. multocida and B. bronchiseptica was clearly demonstrated in sick pigs, however, no post treatment sampling was done to show bacteriological cure.
Fil- prova klinika pivitali, il- preżenza ta ’ P. multocida u B. bronchiseptica ġiet murija b’ mod ċar f’ majjali morda, madankollu, ma ttieħed ebda kampjun wara t- trattament biex juri kura batterjoloġika.
The applicant justifies that the presence of M. hyopneumoniae was not determined by bacteriological methods because it was difficult to isolate at that time.
L- applikant jiġġustifika li l- preżenza ta ’ M. hyopneumoniae ma kinitx stabbilita b’ metodi batterjoloġiċi minħabba li kien diffiċli li din tiġi iżolata f’ dak il- ħin.
The presence was assumed.
Il- preżenza kienet preżunta.
The applicant provided evidence of efficacy of the active substance, doxycycline, against M. hyopneumoniae in pigs from published literature and from MIC studies.
L - applikant ipprovda evidenza ta ’ l- effikaċja tas- sustanza attiva, doxycycline, kontra M. hyopneumoniae fil- majjali minn letteratura ppubblikata u minn studji tal- MIC.
These are all references provided with the original submission.
Dawn huma r- referenzi kollha pprovduti mas- sottomissjoni oriġinali.
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Madankollu, il- CVMP ikkunsidra li l- fatt li ma tteħdux 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. kampjuni batterjoloġiċi wara t- trattament ifisser li ma tistax tiġi preżunta jew iddikjarata kura batterjoloġika.
The CVMP recommended the granting of the marketing authorisation to Doxyprex 100 mg/ g Premix for medicated feeding stuff for pigs for the following indication because a positive benefit/ risk analysis has been demonstrated and no potential serious risk has been identified.
Il- CVMP irrakkomanda l- għoti ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għal Doxyprex 100 mg/ g Premix għal għalf immedikat għall- majjali għall- indikazzjoni segwenti minħabba li ntweriet analiżi pożittiva tal- benefiċċju/ riskju u ma ġie identifikat l- ebda riskju potenzjali serju.
“ For the treatment and prevention of porcine respiratory disease, caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to doxycycline, when the disease has been diagnosed in the herd .”
“ Għat- trattament u l- prevenzjoni tal- marda respiratorja fil- majjali, ikkawżata minn Pasteurella multocida u Bordetella bronchiseptica, suxxettibbli għal doxycycline, meta l- marda tkun ġiet dijanjostika fil- merħla. ”
A benefit-risk analysis could not be conducted due to the lack of pivotal evidence on clinical efficacy for the indication M. hyopneumoniae.
Ma setgħetx titwettaq analiżi tal- benefiċċju- riskju minħabba n- nuqqas ta ’ evidenza pivitali dwar l - effikaċja klinika għall- indikazzjoni M. hyopneumoniae.
Therefore, the recommendation is to remove this pathogen from the indications.
Għalhekk, ir- rakkomandazzjoni hija sabiex dan il- patoġenu jitneħħa mill- indikazzjonijiet.
The CVMP Opinion was adopted on 14 February 2007 and the subsequent Commission Decision on 22 May 2007.
L- Opinjoni tas- CVMP ġiet adottata fl- 14 ta ’ Frar 2007 u d- Deċiżjoni suċċessiva tal- Kummissjoni ġiet adottata fit- 22 ta ’ Mejju 2007.
EMEA/ 532206/ 2007- Rev.1
EMEA/ 532206/ 2007 - Rev. 1- MT
London, 18 February 2008 EMEA/ 48261/ 2008
Londra, 18 ta ’ Frar 2008 EMEA/ 48261/ 2008
COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)
IL- KUMITAT GĦALL- PRODOTTI MEDIĊINALI GĦAL UŻU VETERINARJU (CVMP)
OPINION FOLLOWING AN ARTICLE 33 1 REFERRAL FOR Ecomectin 18.7 mg/ g Oral Paste for Horses and its associated names International Non-Proprietary Name (INN):
OPINJONI WARA RIFERIMENT TAĦT L- ARTIKOLU 331 GĦAL Ecomectin 18. 7 mg/ g Pejst Orali għaż- Żwiemel u l- ismijiet assoċjati tiegħu Denominazzjoni Komuni Internazzjonali (DKI):
Ecomectin 18.7 mg/ g Oral Paste for Horses is a white homogenous paste containing ivermectin.
Ecomectin 18. 7 mg/ g Pejst Orali għaż- Żwiemel huwa pejst abjad omoġenju li fih ivermectin.
Ivermectin is a member of the macrocyclic lactone class of endectocides.
Ivermectin huwa membru tal- klassi tal- macrocyclic lactone ta 'l- endektoċidi.
Ecomectin 18.7 mg/ g Oral Paste for Horses is intended to be used in horses for the treatment of nematode or arthropod infections caused by Strongylus vulgaris, Strongylus edentatus, Strongylus equinus, Small strongyles (including benzimidazole resistant strains):
Ecomectin 18. 7 mg/ g Pejst Orali għaż- Żwiemel huwa maħsub biex jintuża fiż- żwiemel għall- kura ta ’ infezzjonjiet minn nematodi jew artropodi kkawżati minn Strongylus vulgaris, Strongylus edentatus, Strongylus equinus, stronġili żgħar (inklużi razez reżistenti għal benzimidazole):
Cyathostomum spp, Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp., Gyalocephalus spp., Ascarids:
Cyathostomum spp, Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp., Gyalocephalus spp., Askaridi:
Parascaris equorum, Pinworms:
Parascaris equorum, Pinworms (Ħniex):
Oxyuris equim, Neck threadworms:
Oxyuris equim, Neck threadworms (Ħniex):
Onchocerca spp, Stomach bots:
Onchocerca spp, qurdien ta ’ l - istonku:
A marketing authorisation for Ecomectin 18.7 mg/ g Oral Paste for Horses was previously granted to Eco Animal Health Ltd in Ireland on 10 November 2006.
Kienet ingħatat awtorizzazzjoni għat- tqegħid fis- suq għal Ecomectin 18. 7 mg/ g Pejst Orali għaż - Żwiemel lil Eco Animal Health Ltd fl- Irlanda fl- 10 ta ’ Novembru 2006.
A mutual recognition procedure was started on 1 February 2007.
Fl- 1 ta ’ Frar 2007 nbdiet proċedura ta ’ rikonoxximent reċiproku.
The Reference Member State was Ireland and the Concerned Member States were Belgium, Cyprus, Czech Republic, Germany, Denmark, Greece, Spain, Finland, France, Hungary, Italy, the Netherlands, Norway, Portugal, Sweden and the United Kingdom.
L- Istat Membru ta ’ Referenza kien l - Irlanda u l- Istati Membri Konċernati kienu l- Belġju, Ċipru, ir- Repubblika Ċeka, il- Ġermanja, id - Danimarka, il- Greċja, Spanja, il- Finlandja, Franza, l- Ungerija, l- Italja, l- Olanda, in- Norveġja, il - Portugall, l- Iżvezja u r- Renju Unit.
The product was accepted by the Belgium, Cyprus, Czech Republic, Denmark, Greece, Spain, Finland, France, Hungary, Italy, the Netherlands, Norway, Portugal, Sweden and the United Kingdom.
Il- prodott ġie aċċettat mill- Belġju, Ċipru, ir- Repubblika Ċeka, id - Danimarka, il- Greċja, Spanja, il- Finlandja, Franza, l- Ungerija, l- Italja, l- Olanda, in- Norveġja, il - Portugall, l- Iżvezja u r- Renju Unit.
Concerns were raised by Germany regarding that this veterinary medicinal product may present a potential serious risk to public health on the following grounds:
Tqajjem tħassib mill- Ġermanja minħabba li dan il- prodott mediċinali veterinarju jista ’ jippreżenta riskju potenzjali serju għas- saħħa pubblika abbażi ta ’ dan li ġej:
An environmental risk was detected during the risk assessment Phase II Tier A for dung fauna organisms;
Instab riskju ambjentali waqt il- Fażi II Livell A tal- valutazzjoni tar- riskju għall- organiżmi tal - o fawna li jgħixu fid- demel; Ma ġietx ipprovduta data adegwata għall- Livell B mill- applikant biex ikunu vvalutati l- effetti o fit- tul fuq organiżmi tal- fawna li jgħixu fid- demel ikkawżati mill- użu tal- prodott.
On 4 July 2007, Ireland notified EMEA that the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMD(v)) failed to reach an agreement regarding Ecomectin 18.7 mg/ g Oral Paste for Horses and its associated names.
Fl- 4 ta ’ Lulju 2007, l- Irlanda għarrfet lill- EMEA li l- Grupp ta ’ Koordinament għar- Rikonoxximent Reċiproku u Proċeduri Deċentralizzati - Veterinarji (CMD( v)) ma laħaqx qbil dwar Ecomectin 18. 7 mg/ g Pejst Orali għaż- Żwiemel u l- ismijiet assoċjati miegħu.
Pursuant to Article 33(4) of Council Directive 2001/ 82/ EC, as amended, the matter has been referred to the CVMP.
Skond l- Artikolu 33( 4) tad- Direttiva tal - Kunsill 2001/ 82/ KE, kif emendata, il- kwistjoni ġiet riferuta lis- CVMP.
The scope of the referral was to whether the environmental risk detected during the risk assessment Phase II Tier A for dung fauna organisms would present a potential serious risk to public health.
L- ambitu tar- riferiment kien dwar jekk ir- riskju ambjentali misjub waqt il- valutazzjoni tar- riskju fil - Fażi II Livell A għal organiżmi tal- fawna li jgħixu fid- demel jippreżentax riskju potenzjali serju għas - saħħa pubblika.
1 Article 33 of Directive 2001/ 82/ EC, as amended 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
1 Artikolu 33 tad- Direttiva 2001/ 82/ KE, kif emendata 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
The arbitration procedure started on 11 July 2007 with the adoption of list of questions.
Il- proċedura ta ’ arbitraġġ inbdiet fil- 11 ta ’ Lulju 2007 bl- adozzjoni ta ’ lista ta ’ mistoqsijiet.
The rapporteur was Dr.
Ir - rapporteur kien Dr.
Urbain and the co-rapporteur was Prof.
Urbain, il- ko- rapporteur kien il- Prof.
The Marketing Authorisation Holder provided written explanations on 12 September 2007.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq ipprovda spjegazzjonijiet bil- miktub fit- 12 ta ’ Settembru 2007.
Oral explanations were presented on 10 October 2007 by the Marketing Authorisation Holder to the Committee.
Fl - 10 ta ’ Ottubru ta ’ l- 2007, id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq ippreżenta spjegazzjonijiet bil- fomm lill- Kumitat.
During its 6-8 November 2007 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by consensus an opinion that since the product is intended for use in a minor species (horses) that is reared and treated similarly to a major species, the conclusions on the Environmental Risk Assessment of the major species apply, and therefore the product should be exempt from providing a Phase II assessment and no risk mitigation measures should be included in the SPC of the product.
Waqt il- laqgħa tiegħu ta ’ bejn is- 6 u t- 8 ta ’ Novembru 2007, is- CVMP, fid- dawl tad- data globali ppreżentata u d- diskussjoni xjentifika fi ħdan il- Kumitat, adotta opinjoni b’ kunsens li billi l- prodott huwa maħsub għall- użu fi speċi minuri (żwiemel) li tkun trabbiet u ġiet ikkurata b’ mod simili għal speċi maġġuri, japplikaw il- konklużjonijiet tal- Valutazzjoni tar- Riskju Ambjentali ta ’ speċi maġġuri, u għalhekk il- prodott għandu jiġi eżentat milli jkun hemm bżonn li tingħata valutazzjoni tal- Fażi II għalih u ma għandhom jiġu inklużi l- ebda miżuri għat- tnaqqis r- riskju fl- SPC tal- prodott.
The list of product names concerned is given in Annex I.
Il- lista ta ’ ismijiet tal- prodott rilevanti qed tingħata fl- Anness I.
The scientific conclusions are provided in Annex II.
Il- konklużjonjiet xjentifiċi jinstabu fl - Anness II.
The final opinion was converted into a Decision by the European Commission on 17 January 2008.
L- opinjoni finali nbidlet f’ Deċiżjoni mill- Kummissjoni Ewropea fis- 17 ta ’ Jannar 2008.
EMEA/ 48261/ 2008
EMEA/ 48261/ 2008- MT
NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER/ APPLICANT(S)
ISEM, GĦAMLA FARMAĊEWTIKA, QAWWA TAL- PRODOTTI MEDIĊINALI, SPEĊI TA ’ L- ANNIMALI, MOD KIF U MNEJN JINGĦATA, U DETENTUR/ APPLIKANT( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ.
EMEA/ CVMP/ 495339/ 2007-EN
EMEA/ CVMP/ 495339/ 2007- MT
November 2007
Novembru 2007
Marketing Authorisation Holder/ Applicant
Detentur/ Applikant ta ’ l - Awtorizzazzjoni għat- Tqegħid fis - Suq
Product invented name
Prodott isem ivvintat
Animal species
Speċi ta ’ Annimali
Frequency and route Recommended dose of administration
Frekwenza u mod ta ’ kif u mnejn jingħata
78 Coombe Road New Malden Surrey KT3 4QS United Kingdom
78 Coombe Road New Malden Surrey KT3 4QS Renju Unit
Ecomectin 18.7 mg/ g Oral Paste for Horses
Ecomectin 18. 7 mg/ g Pejst Orali għaż - Żwiemel
Oral Paste.
Pejst Orali.
Ivermectin 18.7 mg/ g
Pejst Ivermectin abjad omoġenju 18. 7 mg/ g
Horses
Żwiemel