qanastek/EMEA-V3 huggingface dataset:
Looking at the studies taken together, it was more effective than placebo.
Meta wieħed iħares lejn l- istudji meħudin flimkien, DRAXXIN kien effettiv iktar minn plaċebo.
In two of the three studies of IBK, DRAXXIN was more effective than placebo in curing the disease.
F’ żewġ studji minn tlieta ta ’ IBK, DRAXXIN kien aktar effettiv minn plaċebo fil- kura tal - marda.
However, the third study found no difference between the effectiveness of DRAXXIN, oxytetracycline and placebo.
Madankollu, it- tielet studju ma sab ebda differenza bejn l- effikaċja ta ’ DRAXXIN, oxytetracycline u plaċebo.
The reasons for this are not clear.
Ir- raġunijiet għal dan m’ humiex ċari.
What is the risk associated with DRAXXIN?
X’ inhu r- riksju assoċjat ma ’ DRAXXIN?
The subcutaneous injection of DRAXXIN to cattle often causes temporary pain and swelling at the injection site, which can last up to 30 days.
L- injezzjoni taħt il- ġilda ta ’ DRAXXIN fuq il- frat spiss tikkawża uġigħ temporanju jew nefħa fis- sit ta ’ l- injezzjoni, li jista ’ jdum sa 30 jum.
DRAXXIN should not be used in animals that are hypersensitive (allergic) to macrolideantibiotics.
Dawn ir- reazzjonijiet ma ntwerewx f’ majjali wara injezzjoni intramuskolari. Tipi oħrajn ta ’ reazzjoni għall- injezzjoni jippersistu għal madwar 30 jum wara l- injezzjoni fi frat u majjali.
If DRAXXIN accidentally get into the eyes, flush them immediately with clean water.
DRAXXIN ma għandux jintuża f’ annimali li huma sensittivi żżejjed (allerġiċi) għal makrolideantibijotiċi.
In case of accidental self- injection, seek medical advice immediately and show the Package Leaflet or the label to the doctor.
Ma għandux jintuża wkoll fl- istess ħin ma ’ antibijotiċi makrolidi jew linkosamidi oħra (tip ieħor ta ’ mediċina antibijotika), fi frat li jkunu qegħdin jipproduċu l - ħalib għall- konsum mill- bniedem fi żmien xahrejn mid- data mistennija ta ’ meta jkunu se jwelldu.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption?
Kemm għandu jgħaddi żmien qabel jinqatel l- annimal u qabel ma l- laħam tiegħu jkun jista ’ jiġi kkunsmat?
For cattle intended for consumption as either meat or offal, 49 days must be allowed before slaughter.
Għal frat maħsub għall- konsum jew bħala laħam jew bħala ġewwieni, għandhom jgħaddu 49 ġurnata qabel il- qatla.
For pigs intended for consumption as either meat or offal, 33 days must be allowed.
Għal majjali maħsubin għall- konsum jew bħala laħam jew bħala ġewwieni, għandhom jgħaddu 33 jum.
What is the time to allow before milk can be taken from the animal for human consumption?
Kemm għandu jgħaddi żmien qabel il- ħalib ikun jista ’ jittieħed mill- annimal għall- konsum mill - bniedem?
DRAXXIN must not be used in cattle that are producing milk for human consumption, or in pregnant cows intended to produce milk for human consumption within two months of their expected date of giving birth.
DRAXXIN ma għandux jintuża fi frat li qegħdin jipproduċu ħalib għall- konsum mill - bniedem, jew f’ baqar li jkunu tqal (ikun se jkollhom iż- żgħar) maħsubin għall- produzzjoni ta ’ ħalib għall- konsum mill- bniedem fi żmien xahrejn mid- data li fiha jkunu mistennija li jwelldu.
Why has DRAXXIN been approved?
Għaliex ġie approvat DRAXXIN?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of DRAXXIN exceed the risks for the treatment and prevention of BRD and the treatment of IBK in cattle, and for the treatment and prevention of SRD in pigs, and recommended that DRAXXIN be given a marketing authorisation.
Il- Kumitat għal Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ DRAXXIN jisbqu r- riskji għat- trattament u l- prevenzjoni ta ’ BRD u t- trattament ta ’ IBK fil- frat, u għat- trattament u l- prevenzjoni ta ’ SRD fil- majjali, u rrakkomanda li DRAXXIN jingħata awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ bejn il- benefiċċju u r- riskju jista ’ jinstab f’ modulu 6 ta ’ l- EPAR.
Other information about DRAXXIN:
Tagħrif ieħor dwar DRAXXIN:
The European Commission granted a marketing authorisation valid throughout the European Union for DRAXXIN to Pfizer Limited on 23 July 2003.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal DRAXXIN lil Pfizer Limited fit- 23 ta ’ Lulju 2003.
Information on the prescription status of this product may be found on the label/ outer package.
Tagħrif dwar l - istejtus tal- preskrizzjoni ta ’ dan il- prodott jista ’ jinstab fuq it- tikketta/ pakkett ta ’ barra.
This summary was last updated on 3 October 2007.
Dan is- sommarju ġie aġġornat l- aħħar fit- 3 ta ’ Ottubru 2007.
EU Number
Numru ta ’ l- UE Isem
Pharmaceutical form
Speċi li fuqhom
Route of administration
Mod ta ’ Ippakkja Kontenut Daqs tal -
Target species
kummerċjali
Content (concentration)
Farmaċewtika għandu jintuża l - prodott
Package Packaging size
Ammini - r strazzjoni
Withdrawal period
Tiżmim 1
Solution for injection
Soluzzjoni għal Injezzjoni waħda taħt
Subcutaneous use (cattle) intramuscular use (pigs)
Kunjett
Cattle, pigs
Kaxxa tal- kartun
Glass vial
Baqar (laħam u
Cardboard box with one vial
il- ġilda (Baqar) Injezzjoni waħda fil - muskolu ta ’ l- għonq (Majjali)
Meat and offal:
tal- ħġieġ
Cattle1:
interjuri):
49 days Pigs:
49 ġurnata Majjal:
33 days
33 ġurnata
Solution for injection
Soluzzjoni għal
Subcutaneous use (cattle) intramuscular use (pigs)
Injezzjoni waħda taħt
Cattle, pigs
Baqar,
Glass vial
Kunjett
Cardboard box with one vial
il- ġilda (Baqar)
Cattle1:
li fiha hemm interjuri):
49 days Pigs:
49 kunjett waħda ġurnata Majjal:
EU/ 2/ 03/ 041/ 004 DRAXXIN 100 mg/ ml
Kaxxa tal- kartun 1Baqar (laħam u EU/ 2/ 03/ 041/ 004 DRAXXIN
Subcutaneous use (cattle)
Soluzzjoni għal
Cattle
Injezzjoni waħda taħt Baqar
49 days
49
EU/ 2/ 03/ 041/ 005 DRAXXIN 100 mg/ ml
Kaxxa tal- kartun 1Baqar (laħam u EU/ 2/ 03/ 041/ 005 DRAXXIN
Subcutaneous use Cattle (cattle)
Injezzjoni waħda taħt Baqar
1 Not for use in lactating cattle producing milk for human consumption.
1 Mhux permess l- użu f’ baqar li qed jaħilbu u li l- ħalib tagħhom qed imur għal konsum tan- nies.
Not for use in pregnant cows or heifers, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Tużax f’ baqar ħbiela jew erieħ, li hu maħsub li ser jagħtu ħalib għal konsum tan- nies, sa xahrejn qabel iwelldu.
DRAXXIN 100 mg/ ml solution for injection for cattle and pigs
DRAXXIN 100 mg/ ml soluzzjoni għal injezzjoni għal baqar u majjali.
Active substance(s):
Sustanza Attiva
Excipient(s):
Ingredjenti Oħra
Cattle and pigs
Baqar u majjali
Cattle Treatment and prevention of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis sensitive to tulathromycin.
Baqar Trattament u prevenzjoni tal- marda respiratorju tal- baqar (BRD) assoċjata ma ’ Mannheimia, Pasteurella multocida, Histophilus somni u Mycoplasma bovis sensittivi għal tulathromycin.
The presence of the disease in the herd should be established before preventative treatment.
Il - preżenza tal- marda fil- merħla għanda tiġi stabbilita qabel jingħata trattament preventiv.
Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis sensitive to tulathromycin.
Trattament ta ’ infectious bovine keratoconjunctivitis (IBK) assoċjata ma ’ Moraxella bovis sensittiva ghat- tulathromycin.
Pigs Treatment and prevention of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, and Haemophilus parasuis sensitive to tulathromycin.
Majjali Trattament u prevenzjoni tal- marda respiratorja tal- majjali (SRD) assoċjata ma ’ Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae u Haemophilus parasuis sensittivi għal tulathromycin.
The presence of the disease in the herd should be established before preventative treatment.
Il- preżenza tal- marda fil- merħla għanda tiġi stabbilita qabel jingħata trattament preventiv.
Draxxin should only be used if pigs are expected to develop the disease within 2-3 days.
DRAXXIN għandha tintuża biss jekk hu mistenni li l- majjali ser jiżviluppaw il - marda fi żmien 2- 3- ijiem.
Do not use in case of hypersensitivity of the target animals to macrolide antibiotics.
Tużax f’ każ li l- annimali li fuqhom għandu jintuża, juru sensittivita ’ għolja għal antibijotiċi tal- grupp makrolidi.
Do not use the product simultaneously with other macrolides or lincosamides (see section 4.8).
Tużax fl- istess ħin li jkunu qed jintużaw makrolidi oħrajn jew linkosamidi (ara sezzjoni 4. 8).
Do not use in lactating cattle producing milk for human consumption.
Tużax f’ baqar li qed jaħilbu u li l- ħalib tagħhom qed imur għal konsum tan- nies.
Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Tużax f’ baqar ħbiela jew erieħ, li hu maħsub li ser jagħtu ħalib għal konsum tan- nies, sa xahrejn qabel iwelldu.
2 4.4 Special warnings for each target species
2 4. 4 Twissijiet speċjali < għal kull speċi li għaliha hu indikat il- prodott >
Special precautions for use in animals
L- użu għandu jkun ibbażat fuq testijiet tas- suxxettibilita ’ u għandha tkun ikkunsidrata l- politika uffiċjali u lokali dwar l- użu ta ’ l- antibijotiċi.
Use of the product should be based on susceptibility testing and take into account offical and local antimicrobial policies.
Prekawzjonijiet speċjali għall- użu fl- annimali
Tulathromycin is irritating to eyes.
Tulathromycin tirrita l- għajnejn.
If accidental eye exposure occurs, flush the eyes immediately with clean water.
F’ każ aċċidentali li fih jintlaqtu l- għajnejn, laħlaħ fil- pront b’ ilma nadif.
Tulathromycin may cause sensitisation by skin contact.
Tulathromycin tista ’ tikkawża sensittivita ’ tal- ġilda.
If accidental skin exposure occurs, wash the skin immediately with soap and water.
F’ każ aċċidentali li fih tintlaqat il- ġilda, aħsel fil - pront bis- sapun u bl- ilma.
Wash hands after use.
Aħsel idejk wara li tużah.
In case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician.
F’ każ li aċċidentalment tinjetta lilek innifsek, fittex parir mediku fil- pront u uri l- fuljett ta ’ tagħrif jew it- tikketta lit- tabib.
Subcutaneous administration of DRAXXIN to cattle frequently causes transient pain reactions and local swellings at the injection site that can persist for up to 30 days.
Amministrazzjoni ta ’ DRAXXIN taħt il- ġilda fil- baqar ta ’ spiss twassal għal reazzjonijiet ta ’ uġiegħ li jgħaddi u nefħiet lokaliżżati fil- post ta ’ l- injezzjoni li jistgħu jibqgħu sa 30 ġurnata.
No such reactions have been observed in pigs after intramuscular administration.
Reazzjonijiet bħal dawn ma ġewx osservati f’ majjali wara amministrazzjoni fil- muskolu.
Pathomorphological injection site reactions are present for approximately 30 days after injection in both species.
Reazzjonijiet patomorfoloġiċi jidhru fil- post ta ’ l- injezzjoni bejn wieħed u ieħor għal 30 ġurnata wara l- injezzjoni fiż- żewġ speċi.
4.7 Use during pregnancy, lactation or lay
4. 7 Użu fit- Tqala, fi żmien il- ħalib
Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.
Studji fil- laboratorju fuq ġrieden u fniek ma rriżultawx f’ evidenza ta ’ effetti teratoġeniċi, jew effetti li jagħmlu ħsara lill- fetu jew lill- omm.
The safety of tulathromycin during pregnancy and lactation has not been established in cattle and pigs.
Il- ħarsien tas- saħħa ta ’ tulathromycin waqt it- tqala u fi żmien il - ħalib ma ġietx stabbilita fil- baqar u fil- majjali.
Use only according to the benefit/ risk assessment by the responsible veterinarian.
Uża biss skond il- valutazzjoni tal- benefiċċju u r- riskju tal- veterinarju responsabbli.
Cross resistance occurs with other macrolides.
Reżistenza inkroċjata isseħħ ma ’ makrolidi oħra.
Do not administer simultaneously with antimicrobials with a similar mode of action such as other macrolides or lincosamides.
Tużax fl- istess ħin ma ’ sustanzi għal kontra l - mikrobi li jaħdmu bl- istess mod, bħal ma huma makrolidi oħra u linkosamidi.
Cattle A single subcutaneous injection of 2.5 mg tulathromycin/ kg body weight (equivalent to 1 ml/ 40 kg body weight).
Baqar Injezzjoni waħda taħt il- ġilda ta ’ 2. 5 mg tulathromycin/ kg piż (ekwivalenti għal 1 ml/ 40 kg piż).
For treatment of cattle over 300 kg body weight, divide the dose so that no more than 7.5 ml are injected at one site.
Għal trattament ta ’ baqar ‘ il fuq minn 300 kg, aqsam id- doża biex f’ kull post ta ’ l- injezzjoni ma jingħatawx aktar minn 7. 5 ml.
3 Pigs A single intramuscular injection of 2.5 mg tulathromycin/ kg body weight (equivalent to 1 ml/ 40 kg body weight) in the neck.
3 Majjali Injezzjoni waħda fil- muskolu ta ’ l- għonq ta ’ 2. 5 mg tulathromycin/ kg piż (ekwivalenti għal 1 ml/ 40 kg piż).
For treatment of pigs over 80 kg body weight, divide the dose so that no more than 2 ml are injected at one site.
Għal trattament ta ’ majjali ‘ l fuq minn 80 kg piż, aqsam id- doża biex f’ kull post ta ’ l- injezzjoni ma jingħatawx aktar minn 2 ml.
It is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 48 hours after injection.
Huwa rrakkomandat li t- trattament jibda fi stadji kmieni tal- mard u l- effett tal- trattament għandu jiġi evalwat fi żmien 48 siegħa mill- injezzjoni.
If clinical signs of respiratory disease persist or increase, or if relapse occurs, treatment should be changed, using another antibiotic, and continued until clinical signs have resolved.
Jekk is- sinjali kliniċi ta ’ mard respiratorju jibqgħu jidhru jew jiżdiedu, jew il- mard jerġa ’ jfiġġ, il- trattament għandu jinbidel, b’ użu ta ’ antibijotiku ieħor, u jibqa ’ sejjer sakemm is- sinjali kliniċi jmorru.
To ensure correct dosage body weight should be determined as accurately as possible to avoid underdosing.
Sabiex tassigura dożaġġ tajjeb, il- piż tal- bhima għandu jittieħed kemm jista jkun sewwa sabiex tevita li jingħata dożaġġ baxx.
For multiple vial entry, an aspirating needle or multi-dose syringe is recommended to avoid excessive broaching of the stopper.
Meta ttaqqab il- kunjett bosta drabi, hu rakkomandat li tuża labra li tħalliha fil - kunjett jew siringa li tesa aktar minn doża waħda sabiex tevita li tagħmel ħafna toqob fit- tapp.
In cattle at dosages of three, five or ten times the recommended dose, transient signs attributed to injection site discomfort were observed and included restlessness, head-shaking, pawing the ground, and brief decrease in feed intake.
B’ dożi ta ’ tlieta, ħamsa jew għaxar darbiet aktar mid- doża rakkomandata fil- baqar, kien hemm sinjali li jgħaddu kawża ta ’ skumdita, fil- post ta ’ l- injezzjoni li wassal biex l- annimali ma jkollhomx kwiet, ixenglu rashom, jagħtu b’ saqajhom ma l- art u jnaqqsu mill- ikel għal ftit taż- żmien.
Mild myocardial degeneration has been observed in cattle receiving 5-6X the recommended dose.
Kienet osservata deġenerazzjoni ħafifa tal- muskolu tal- qalb f’ dawk il- baqar li ngħataw ħames jew sitt darbiet aktar mid - doża rakkomandata.
In young pigs weighing approximately 10 kg given three or five times the therapeutic dose transient signs attributed to injection site discomfort were observed and included excessive vocalisation and restlessness.
F’ majjali żgħar ta ’ xi 10 kg li ingħataw dożi ta ’ tlieta jew ħames darbiet aktar mid- doża rakkomandata, kien hemm sinjali li jgħaddu minħabba skumdita fil- post ta ’ l- injezzjoni li wassal għal twerżieq eċċessiv u nuqqas ta ’ serħan.
Lameness was also observed when the hind leg was used as the injection site.
Meta l- injezzjoni ngħatat fis- sieq ta ’ wara, l- annimali dehru jzappu.
Cattle (meat and offal):
Baqar (laħam u interjuri):
49 days
49 ġurnata
Pig (meat and offal):
Majjal (laħam u interjuri):
Not permitted for use in lactating cattle producing milk for human consumption.
Mhux permess l- użu f’ baqar li qed jaħilbu u li l- ħalib tagħhom qed imur għal konsum tan- nies.
Macrolide, ATCvet code:
Makrolid, Kodiċi ATC veterinarja:
Tulathromycin is a semi-synthetic macrolide antimicrobial agent, which originates from a fermentation product.
Tulathromycin hija sustanza makrolida semi- sintetika għal kontra l- mikrobi, li toriġina minn prodott ta ’ fermentazzjoni.
It differs from many other macrolides in that it has a long duration of action that is, in part, due to its three amine groups; therefore it has been given the chemical subclass designation of triamilide.
Hija differenti minn ħafna makrolidi oħra billi l- effett tagħha huwa twil, dan minħabba l- fatt li għandha tlett gruppi amini, u għalhekk ġiet mqiegħda fis- sotto- klassi triamilide.
Macrolides are bacteriostatic acting antibiotics and inhibit essential protein biosynthesis by virtue of their selective binding to bacterial ribosomal RNA.
Il- makrolidi huma antibijotiċi batterjostatiċi u jimblokkaw il- biosintesi ta ’ proteini essenzjali billi b’ mod selettiv jeħlu mar- ribosomal RNA tal- mikrobi.
They act by stimulating the dissociation of peptidyl-tRNA from the ribosome during the translocation process.
Huma jaħdmu billi jistimulaw il- qasma tal - peptidyl- tRNA minn mar- ribosoma waqt il- proċess ta ’ translokazzjoni.
Tulathromycin possesses in vitro activity against Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis, and Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoni, and Haemophilus parasuis the bacterial pathogens most commonly associated with bovine and swine respiratory disease, respectively.
Tulathromycin għandha attivita ’ in vitro kontra Mannheimia haemolytica, Pasteurella multocida, Histophilus somni u Mycoplasma bovis, u Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae u Haemophilus parasuis il- mikrobi patogeniċi li huma l- aktar assoċjati ma ’ mard respiratorju tal- baqar u tal- majjali, rispettivament.
Increased MIC values have been found in some isolates of Histophilus somni and Actinobacillus pleuropneumoniae.
Instabu livelli aktar għoljin fl- MIC f’ xi iżolati batterjoloġiċi ta ’ Histophilus somni u Actinobacillus pleuropneumonia.
4 Tulathromycin also possesses in vitro activity against Moraxella bovis, the bacterial pathogen most commonly associated with infectious bovine keratoconjunctivitis (IBK).
4 Tulathromycin għandha ukoll attivita ’ in vitro kontra Moraxella bovis u Neisseria spp., il- mikrobi assoċjati l- aktar ma ’ infectious bovine keratoconjunctivitis (IBK).
Resistance to macrolides can develop by mutations in genes encoding ribosomal RNA (rRNA) or some ribosomal proteins; by enzymatic modification (methylation) of the 23S rRNA target site, generally giving rise to cross-resistance with lincosamides and group B streptogramins (MLSB resistance); by enzymatic inactivation; or by macrolide efflux.
Ir- reżistenza għal makrolidi tista ’ tiżviluppa permezz ta ’ mutazzjonijiet fil- genes li jġorru l- kodiċi ta ’ ribosomal RNA (rRNA) jew ta ’ xi proteini tar- ribosome; b’ modifikazzjoni enżimatiku fit- 23S rRNA target site, li ġeneralment iwassal għal reżistenza inkroċjata mal- linkosamidi u streptogramins tal - grupp B (reżistenza MLSB); bit- twaqqif fl- attivita ’ permezz ta ’ l- enżimi; jew bi ħruġ ta ’ makrolidi.
MLSB resistance may be constitutive or inducible.
Ir - reżistenza MLSB tista ’ tkun kostitutiva jew induċibbli.
Resistance may be chromosomal or plasmid-encoded and may be transferable if associated with transposons or plasmids.
Ir- reżistenza tista ’ tkun kromosomali jew plasmid- encoded u tista ’ tkun trasferibbli jekk tkun assoċjata ma ’ transposons jew plasmidi.
In cattle, the pharmacokinetic profile of tulathromycin when administered as a single subcutaneous dose of 2.5 mg/ kg body weight, was characterised by rapid and extensive absorption followed by high distribution and slow elimination.
Fil- baqar, il- profil farmakokinetiku ta ’ tulathromycin meta tingħata f’ doża waħda taħt il- ġilda ta ’ 2. 5 mg/ kg piż, kien ikkaratteriżat minn assorbiment estensiv u ta ’ malajr segwit minn distribuzzjoni għolja u eliminazzjoni bil- mod.
The maximum concentration (Cmax) in plasma was approximately 0.5 µg/ ml; this was achieved approximately 30 minutes post-dosing (Tmax).
L- għola livell (Cmax) fil- plażma kien bejn wieħed u ieħor ta ’ 0. 5 µg/ ml; dan intlaħaq bejn wieħed u ieħor 30 minuta wara li ngħatat id- doża (Tmax).
Tulathromycin concentrations in lung homogenate were considerably higher than those in plasma.
Il- livelli ta ’ tulathromycin f ’ ħomoġinat tal- pulmun kienu konsiderevolment għola minn dawk fil- plażma.
There is strong evidence of substantial accumulation of tulathromycin in neutrophils and alveolar macrophages.
Hemm evidenza ċara li jkun hemm ħażna ta ’ tulathromycin fin- newtrofili u makrofaġi ta ’ l- alvejoli.
However, the in vivo concentration of tulathromycin at the infection site of the lung is not known.
Madankollu, il- livelli ta ’ tulathromycin in vivo fil- post ta ’ nfezzjoni fil- pulmun, mhumiex magħrufa.
Peak concentrations were followed by a slow decline in systemic exposure with an apparent elimination half-life (t1/ 2) of 90 hours in plasma.
Wara li ntlaħqu l- ogħla livelli kien hemm tnaqqis bil- mod ta ’ preżenza fis- sistema, b’ half life ta ’ eliminazzjoni (t1/ 2) mill - plażma li jidher li hu ta ’ 90 siegħa.
Plasma protein binding was low, approximately 40%.
L- ammont abbinat mal- proteini tal- plażma huwa baxx, u bejn wieħed u ieħor huwa ta ’ 40%.
The volume of distribution at steady-state (Vss) determined after intravenous administration was 11 L/ kg.
Il- volum ta ’ distribuzzjoni fi stat stabbli (Vss) iddeterminat wara amministrazzjoni fil- vina kien ta ’ 11 L/ kg.
The bioavailability of tulathromycin after subcutaneous administration in cattle was approximately 90%.
Il- bioavilibilita ta ’ tulathromycin wara amministrazzjoni taħt il- ġilda fil- baqar kienet bejn wieħed u ieħor ta ’ 90%.
In pigs, the pharmacokinetic profile of tulathromycin when administered as a single intramuscular dose of 2.5 mg/ kg body weight, was also characterised by rapid and extensive absorption followed by high distribution and slow elimination.
Fil- majjali, il- profil farmakokinetiku ta ’ tulathromycin meta tingħata f’ doża waħda ta ’ 2. 5 mg/ kg piż, fil- muskolu, kien ukoll ikkaratteriżat minn assorbiment estensiv u ta ’ malajr segwit minn distribuzzjoni għolja u eliminazzjoni bil- mod.
The maximum concentration (Cmax) in plasma was approximately 0.6 µg/ ml; this was achieved approximately 30 minutes post-dosing (Tmax).
L- għola livell (Cmax) fil- plażma kien bejn wieħed u ieħor ta ’ 0. 6 µg/ ml; dan intlaħaq bejn wieħed u ieħor 30 minuta wara li ingħatat id- doża (Tmax).
Tulathromycin concentrations in lung homogenate were considerably higher than those in plasma.
Il - livelli ta ’ tulathromycin f’ omoġinat tal- pulmun kienu konsiderevolment għola minn dawk fil- plażma.
However, the in vivo concentration of tulathromycin at the infection site of the lung is not known.
Madankollu, il- livelli ta ’ tulathromycin in vivo fil- post ta ’ infezzjoni fil- pulmun, mhumiex magħrufa.
Peak concentrations were followed by a slow decline in systemic exposure with an apparent elimination half-life (t1/ 2) of approximately 91 hours in plasma.
Wara li ntlaħqu l- ogħla livelli kien hemm tnaqqis bil- mod ta ’ Tulathromycin fis- sistema, b’ half life ta ’ eliminazzjoni (t1/ 2) mil- plażma li jidher li hu ta ’ 91 siegħa.
The volume of distribution at steady-state (Vss) determined after intravenous administration was 13.2 L/ kg.
Il- volum ta ’ distribuzzjoni fi stat stabbli (Vss) iddeterminat wara amministrazzjoni fil- vina, kien ta ’ 13. 2 L/ kg.
The bioavailability of tulathromycin after intramuscular administration in pigs was approximately 88%.
Il- bioavalibilita ta ’ tulathromycin wara amministrazzjoni fil- muskolu fil- majjali kienet bejn wieħed u ieħor ta ’ 88%.
Monothioglycerol Propylene glycol Citric acid Hydrochloric acid Sodium hydroxide Water for injections
Monothioglycerol Propylene glycol Citric acid Hydrochloric acid Sodium hydroxide Ilma għall- injezzjoni
In the absence of incompatibility studies, DRAXXIN must not be mixed with other veterinary medicinal products.
Billi m’ hemmx studji ta ’ nkompatibilitajiet, DRAXXIN m’ għandhiex titħallat ma ’ prodotti mediċinali veterinarji oħra.
5 6.3 Shelf life
5 6. 3 Żmien ta 'kemm il- prodott idum tajjeb
Shelf life:
Żmien li l- prodott jista ’ jinżamm fuq l- ixkaffa ippakkjat:
3 years
3 - snin
In use shelf life:
Żmien li l- prodott jibqa ’ tajjeb waqt l- użu:
No special precautions for storage.
M’ hemmx prekawzjonijiet speċjali sabiex taħżen dan il- prodott.
Primary packaging:
Ippakkjar primarju:
Type 1 glass vial with a fluoropolymer coated chlorobutyl stopper and an aluminium overseal.
Kunjett tal- ħġieġ ta ’ Tip 1 b’ tapp tal- klorobutil b’ kisja ta ’ fluoropolymer u b’ siġill ta ’ l- aluminju fuq kollox.
Secondary packaging:
Ippakkjar sekondarju:
Cardboard box containing one vial.
Kaxxa tal- kartun li fiha hemm kunjett waħda
Vial sizes:
Daqsijiet tal- kunjett:
20 ml, 50 ml, 100 ml, 250 ml, and 500 ml Not all vial sizes may be marketed.
20 ml, 50 ml, 100 ml, 250 ml, u 500 ml Jista ’ jkun li mhux id- daqsijiet kollha tal- kunjetti jkunu fuq is- suq.
250 ml and 500 ml vials must not be used for pigs.
Il- kunjetti ta ’ 250 ml u 500 ml m’ għandhomx jintużaw fuq il- majjali.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Mediċina veterinarja li ma ġietx użata jew materjal żejjed ġej minn dawn il- prodotti veterinarji, għandhom jintremew skond kif jitolbu ħtiġijiet lokali.
First authorisation:
L- ewwel awtorizzazzjoni:
11/ 11/ 2003 Renewal:
Tiġdid:
19/ 09/ 2008
11/ 11/ 2003 19/ 09/ 2008
19/ 09/ 2008
< {MM/ YYYY} > jew < month YYYY} > …
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 / >
6 PROHIBITION OF SALE, SUPPLY AND/ OR USE
6 ANNESS II
Not applicable.
DIKJARAZZJONI TA ’ L- MRLs
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
MANIFATTUR TAS- SUSTANZA BIOLOĠIKA ATTIVA AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LOTT
STATEMENT OF THE MRLs
U SID TA ’ L - MILL- HRUĠ TAL -
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Isem u indirizz tal- manufattur tas- sustanza bioloġika attiva Pfizer PGM Z. I. d’ Amboise F- 37530 Pocé- sur- Cisse Franza
Name and address of the manufacturer(s) responsible for batch release
Awtorizzazzjoni tal- Manifattura maħruġa fil- 21 ta ’ Ġunju 2001 mill- Agence Nationale du Médicaments Vétérinaire, Franza.
Pfizer PGM Z. I. d’ Amboise F-37530 Pocé-sur-Cisse France
Pfizer PGM Z. I. d’ Amboise F- 37530 Pocé- sur- Cisse Franza
To be supplied only on veterinary prescription.
Prodott mediċinali veterinarju jingħata bir- riċetta tat- tabib Sid ta 'din l- awtorizzazzjoni tal- kummerċ għandu jagħti tgħarif lill- Kummissjoni Ewropeja dwar il - pjanijiet kummerċjali tal- prodott mediċinali awtorizzat b' din id- deċiżjoni.
Tulathromycin is included in Annex I of Council Regulation (EEC) No 2377/ 90 in accordance with the following table:
Tulathromycin hija inkluża fl- Anness I tar- Regolament tal- Kunsill (KEE) Nru 2377/ 90 skond it- tabella li ġejja:
Pharmacologically
Sustanza( i) farmako - loġikament attiva( i)
Target
Residwu li jimmarka
active substance(s) 1
Speċje ta ’ l- annimal
tissues
Tessuti mmirati
provisions
Dispożizzjonijiet oħrajn
Tulathromycin
Tulathromycin1
(2R, 3S, 4R, 5R, 8R, 10R, Bovine 11R, 12S, 13S, 14R)-2- ethyl-3,4,10,13- tetrahydroxy- 3,5,8,10,12,14-
(2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R) - 2 - ethyl- 3, 4, 10, 13 - tetrahydroxy - 3, 5, 8, 10, 12, 14- hexamethyl - 11 - [[3, 4, 6- trideoxy- 3 -
Fat Liver Kidney
Xaħam Fwied Kliewi
Not for use in lactating cattle producing milk for human consumption.
Mhux permess l - użu f’ baqar li qed jaħilbu u li l- ħalib tagħhom qed imur għal konsum tan- nies.
hexamethyl-11-[[3,4,6- Porcine trideoxy-3- (dimethylamino)-ß-D- xylohexopyranosyl]oxy]- 1-oxa-6- azacyclopentadecan-15-on, expressed as tulathromycin equivalents
oxa- 6- azacyclopentadecan - 15- on, espress bħala ekwivalenti tat - tulathromycin
Skin + fat Liver Kidney
Fwied Kliewi
9 Annex II of Council Regulation (EEC) No 2377/ 90:
8 Anness II tar- Regolament tal- Kunsill (KEE) Nru 2377/ 90:
Pharmacologically active substance Propylene Glycol2 Monothioglycerol3 Citric Acid4
Sustanza farmakoloġikament attiva Propylene Glycol2 Monothioglycerol3 Citric Acid4
Animal Species All food animal species All food animal species All food animal species
Speċje ta ’ l- annimal Speċji kollha ta ’ annimali għall- ikel Speċji kollha ta ’ annimali għall- ikel Speċji kollha ta ’ annimali għall- ikel
All food animal species
Speċji kollha ta ’ annimali għall- ikel
For use as excipient
Għal użu bħala sustanza oħra
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
11 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA (20 ml)
DRAXXIN 100 mg/ ml solution for injection for cattle and pigs
DRAXXIN 100 mg/ ml soluzzjoni għal injezzjoni għal baqar u majjali
Treatment and prevention of bacterial and mycoplasmal infections in cattle and pigs.
Trattament u prevenzjoni ta ’ nfezzjonijiet minn mikrobi u mycoplasma fil- baqar u fil- majjali.
See package leaflet for complete list of indications, sensitive pathogens and directions for use.
Ara l - fuljett ta ’ tagħrif fil- pakett għal lista sħiħa ta ’ indikazzjonijiet, mikrobi sensittivi u struzzjonijiet dwar l- użu.
A single subcutaneous (cattle) or intramuscular (pigs) injection of 2.5 mg tulathromycin/ kg body weight (1 ml/ 40 kg body weight).
Injezzjoni waħda taħt il- ġilda (baqar) jew fil- muskolu (majjali) ta ’ 2. 5 mg tulathromycin/ kg piż (1 ml/ 40 kg piż).
Read the package leaflet before use.
Ara l- fuljett ta ’ tagħrif għal struzzjonijiet sħaħ dwar l- użu.
Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif qabel tużah.
Tulathromycin is irritating to eyes and may cause sensitisation by skin contact.
Tulathromycin tirrita l- għajnejn u tista ’ tikkawża sensittivita ’ jekk tmiss mal- ġilda.
Wash hands after use.
Aħsel idejk wara li tuża.
Expires < mm/yyyy >
Jiskadi {xahar/ sena}
28 days Discard date:
Jekk tiftaħ uża fi żmien 28 ġurnata Data biex tarmi:
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Mediċina veterinarja li ma ġietx użata jew materjal żejjed ġej minn dawn il- prodotti veterinarji, għandhom jintremew skond kif jitolbu ħtieġijiet lokali.
For animal treatment only - to be supplied only on veterinary prescription.
Għat- trattament ta ’ l- annimali biss.
< Batch > < Lot >
< Lott > < lott > < Numru tal- lott > {numru}
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
14 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA (50 ml)
lactating cattle producing milk for human consumption.
Mhux permess l- użu f’ baqar li qed jaħilbu u li l- ħalib tagħhom qed imur għal konsum tan- nies.
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
17 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA (100 ml)
21 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
20 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA (250 ml)
DRAXXIN 100 mg/ ml solution for injection for cattle
DRAXXIN 100 mg/ ml soluzzjoni għal injezzjoni għal baqar
Cattle
Baqar
Treatment and prevention of bacterial and mycoplasmal infections in cattle.
Trattament u prevenzjoni ta ’ nfezzjonijiet minn mikrobi u mycoplasma fil- baqar.
See package leaflet for complete list of indications, sensitive pathogens and directions for use.
Ara l- fuljett ta ’ tagħrif fil- pakett għal lista sħiħa ta ’ indikazzjonijiet, mikrobi sensittivi u struzzjonijiet dwar l- użu.
A single subcutaneous (cattle) injection of 2.5 mg tulathromycin/ kg body weight (1 ml/ 40 kg body weight).
Injezzjoni waħda taħt il- ġilda ta ’ 2. 5 mg tulathromycin/ kg piż (1 ml/ 40 kg piż).
24 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
23 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA (500 ml)
27 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
26 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
< Batch > < Lot >
< Lott > < Lott > < Numru tal- lott > {numru}
Expires < mm/yyyy >
< Jiskadi {xahar/ sena} > < Jekk infetaħ uża fi żmien … >
For animal treatment only.
Għal Trattament tal- Annimali Biss.
28 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
27 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
29 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
28 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
30 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
29 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
31 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
33 PACKAGE LEAFLET DRAXXIN 100 mg/ ml solution for injection for cattle and pigs
32 FULJETT TA ’ TAGĦRIF FIL- PAKKETT DRAXXIN 100 mg/ ml soluzzjoni għal injezzjoni għal baqar u l- majjali
DRAXXIN 100 mg/ ml solution for injection for cattle and pigs
DRAXXIN 100 mg/ ml soluzzjoni għal injezzjoni għal baqar u l- majjali.
Cattle Treatment and prevention of bovine respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis sensitive to tulathromycin.
Baqar Trattament u prevenzjoni tal- marda respiratorju tal- baqar (BRD) assoċjata ma ’ Mannheimia, Pasteurella multocida, Histophilus somni u Mycoplasma bovis sensittivi għal tulathromycin.
Pigs Treatment and prevention of swine respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae and Haemophilus parasuis sensitive to tulathromycin.
Majjali Trattament u prevenzjoni tal- marda respiratorja tal- majjali assoċjata ma ’ Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae u Haemophilus parasuis sensittivi għal tulathromycin.
CONTRAINDICATIONS
33 5 KUNTRADIZZJONIJIET
Do not use in case of hypersensitivity of the target animals to macrolide antibiotics Do not use the product simultaneously with other macrolides or lincosamides Do not use in lactating cattle producing milk for human consumption Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption, within 2 months of expected parturition
Tużax f’ każ li l- annimali li fuqhom għandu jintuża juru sensittivita ’ għolja għal antibijotiċi tal- grupp tal- makrolidi Tużax fl- istess ħin li jkunu qed jintużaw makrolidi oħrajn jew linkosamidi Tużax f’ baqar li qed jaħilbu u li l- ħalib tagħhom qed imur għal konsum tan- nies Tużax f’ baqar ħbiela jew erieħ, li hu maħsub li ser jagħtu ħalib għal konsum tan- nies, sa xahrejn qabel iwelldu
No such reactions have been observed in pigs after intramuscular administration.
Reazzjonijiet bħal dawn ma ġewx innutati fil- majjali wara amministrazzjoni fil- muskolu.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Jekk tinnota xi effetti oħra mhux mistennija, jekk jogħġbok informa lit- tabib veterinarju tiegħek.
Cattle (treatment and prevention) 2.5 mg tulathromycin/ kg body weight (equivalent to 1 ml/ 40 kg body weight).
Baqar (trattament u prevenzjoni) 2. 5 mg tulathromycin/ kg piż (ekwivalenti għal 1 ml/ 40 kg piż)
A single subcutaneous injection.
Injezzjoni waħda taħt il- ġilda.
Pigs 2.5 mg tulathromycin/ kg body weight (equivalent to 1 ml/ 40 kg body weight).
Majjali 2. 5 mg tulathromycin/ kg piż (ekwivalenti għal 1 ml/ 40 kg piż)
A single intramuscular injection in the neck.
Injezzjoni waħda fil- muskolu ta ’ l- għonq.
It is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 48 hours after injection.
Huwa rakkomandat li t- trattament jibda fi stadji kmieni tal- mard u l- effett tat- trattament għandu jigi evalwat fi żmien 48 siegħa mill- injezzjoni.
If clinical signs of respiratory disease persist or increase, or if relapse occurs, treatment should be changed, using another antibiotic, and continued until clinical signs have resolved.
Jekk is- sinjali kliniċi ta ’ mard respiratorju jibqgħu jidhru jew jiżdiedu, jew il- mard jerga ’ jfiġġ, il- trattament għandu jinbidel, b’ użu ta ’ antibijotiku ieħor, u jibqa ’ sejjer sakemm is- sinjali kliniċi jmorru.
Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Mhux permess l- użu f’ baqar li qed jaħilbu u li l- ħalib tagħhom qed imur għal konsum tan- nies Tużax f’ baqar ħbiela jew erieħ, li hu maħsub li ser jagħtu ħalib għal konsum tan- nies, sa xahrejn qabel iwelldu.
Use within 28 days of first opening or broaching the vial.
Uża fi żmien 28 ġurnata minn meta tiftaħ l- ewwel darba jew tniffed il- kunjett.
For the animal:
Għal annimal:
Use of the product should be based on susceptibility testing and take into account offical and local antimicrobial policies.
L- użu għandu jkun ibbażat fuq testijiet tas- suxxettibilita ’ u għandha tkun ikkunsidrata l- politika uffiċjali u lokali dwar l- użu ta ’ l- antibijotiċi.
Do not administer simultaneously with antimicrobials with a similar mode of action such as other macrolides or lincosamides.
Tużax fl- istess ħin ma ’ sustanzi għal kontra l- mikrobi li jaħdmu bl- istess mod, bħal ma huma makrolidi oħra u linkosamidi.
The safety of tulathromycin during pregnancy and lactation has not been established in cattle and pigs.
In- nuqqas ta ’ ħsara ta ’ tulathromycin waqt it- tqala u fi żmien il - ħalib ma ġietx stabbilita fil- baqar u fil- majjali.
In cattle at dosages of three, five or ten times the recommended dose, transient signs attributed to injection site discomfort were observed and included restlessness, head-shaking, pawing the ground, and brief decrease in feed intake.
B’ dożi ta ’ tlieta, ħamsa jew ġhaxar darbiet aktar mid- doża rakkomandata fil- baqar, kien hemm sinjali li jgħaddu kawża ta ’ skumdita fil- post ta ’ l- injezzjoni li wassal biex l- annimali ma jkollhomx kwiet, ixenglu rashom, jagħtu b’ saqajhom u jnaqqsu mill- ikel għal ftit taż- żmien.
For the user:
Għal min se juża:
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
F’ każ li aċċidentalment tinjetta lilek innifsek, fittex parir mediku fil- pront u uri l- fuljett ta ’ tagħrif jew it- tikketta lit- tabib.
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: // emea. europa. eu / >.
Tulathromycin possesses in vitro activity against Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis, and Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, and Haemophilus parasuis the bacterial pathogens most commonly associated with bovine and swine respiratory disease, respectively.
Tulathromycin għandha attivita ’ in vitro kontra Mannheimia haemolytica, Pasteurella multocida, Histophilus somni u Mycoplasma bovis, u Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae u Haemophilus parasuis il- mikrobi patogeniċi li huma l- aktar assoċjati ma ’ mard respiratorju tal- baqar u tal- majjali, rispettivament.
Tulathromycin also possesses in vitro activity against Moraxella bovis, the bacterial pathogen most commonly associated with infectious bovine keratoconjunctivitis (IBK).
Tulathromycin għandha ukoll attivita ’ in vitro kontra Moraxella bovis u Neisseria spp., il- mikrobi assoċjati l- aktar ma ’ infectious bovine keratoconjunctivitis (IBK).
37 In pigs, the pharmacokinetic profile of tulathromycin when administered as a single intramuscular dose of 2.5 mg/ kg body weight, was also characterised by rapid and extensive absorption followed by high distribution and slow elimination.
L- għola livell (Cmax) fil- plażma kien bejn wieħed u
The maximum concentration (Cmax) in plasma was approximately 0.6 µg/ ml; this was achieved approximately 30 minutes post-dosing (Tmax).
36 ieħor ta ’ 0. 6 µg/ ml; dan intlaħaq bejn wieħed u ieħor 30 minuta wara li ingħatat id- doża (Tmax).
Not all pack sizes may be marketed.
Jista ’ jkun li mhux id- daqsijiet kollha tal- pakketti jkunu fuq is- suq.
250 ml and 500 ml vials must not be used for pigs.
Il- kunjetti ta ’ 250 ml u 500 ml m’ għandhomx jintużaw fil- majjali.
For any information about this veterinary medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali veterinarju, jekk jogħġbok ikkuntattja lir - rappreżentant lokali tas- Sid ta ’ l- Awtorizzazzjoni tal- Kummerċ.
DUVAXYN WNV
DUNAXYN WNV
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
L- għan tiegħu huwa li jispjega kif il- valutazzjoni mwettqa mill- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) wasal għar- rakkomandazzjonijiet dwar il- kundizzjonijiet tal- użu abbażi tad - dokumentazzjoni pprovduta.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Jekk teħtieġ iktar informazzjoni dwar il- kundizzjoni medika jew it- trattament tal- annimal tiegħek, ikkuntattja lill- veterinarju tiegħek.
What is Duvaxyn WNV?
X’ inhu Duvaxyn WNV?
Duvaxyn WNV is a vaccine containing an inactivated West Nile virus (inactivated means that the virus has been killed so that it cannot cause the disease any more).
Dunavyn WNV huwa vaċċin li fih vajrus West Nile inattivat (inattivat jiġifieri li l- vajrus inqatel sabiex ma jkunx jista ’ jikkawża iktar il- marda).
What is Duvaxyn WNV used for?
Għalxiex jintuża Duvaxyn WNV?
Duvaxyn WNV is a vaccine used in horses to protect against West Nile virus disease.
Dunaxyn WNV huwa vaċċin li jintuża fiż- żwiemel sabiex jipproteġihom kontra l- marda tal- vajrus West Nile.
The vaccine reduces the number of viraemic horses (these are horses with virus circulating in their blood stream) The vaccine is injected intramuscularly (into a muscle) in the neck of the horse.
Il- vaċċin jiġi injettat fil- muskolu tal- għonq taż- żiemel.
How does Duvaxyn WNV work?
Kif jaħdem Dunavyn WNV?
Duvaxyn WNV is a vaccine.
Dunavyn WNV huwa vaċċin.
When it is given to horses, the animal’ s immune system (their natural defence mechanism) learns how to make antibodies (a special type of protein) to fight the disease.
Meta jingħata liż- żwiemel, is- sistema immunitarja tagħhom (il - mekkaniżmu ta ’ difiża naturali tagħhom) titgħallem kif tipproduċi antikorpi (tip speċjali ta ’ proteina) sabiex tiġġieled il- marda.
In the future, if the horses are exposed to the West Nile virus, the immune system will be able to make those antibodies quicker and this will help them fight the disease.
Fil- futur, jekk iż- żwiemel huma esposti għall- vajrus West Nile, is- sistema immunitarja tkun kapaċi toħloq antikorpi b’ mod aktar mgħaġġel u dan jgħin sabiex jiġġieldu kontra l - marda.
How has Duvaxyn WNV been studied?
Kif ġie studjat Dunavyn WNV?
The company carried out laboratory safety studies in both young foals (6 months of age) and pregnant mares using the vaccine.
Il- kumpanija wettqet studji ta ’ sigurtà fil- laboratorju billi użat il- vaċċin kemm fuq il- moħrien żgħar (f’ età ta ’ 6 xhur) kif ukoll fuq id- dwieb ħobla.
These showed the safety of the use of the vaccine in horses in general and in young (6 months of age or older) and pregnant animals in particular.
Dawn l- istudji wrew b’ mod ġenerali l- użu sigur tal - vaċċin fiż- żwiemel u b’ mod partikolari f’ dawk li jkunu għadhom żgħar (f’ età ta ’ 6 xhur żmien jew aktar) u li jkunu ħobla.
They then performed a number of field trials which further confirmed the safety of Duvaxyn WNV and proved its efficacy in reducing the number of viraemic horses and thereby protecting against the disease.
Saru mbagħad numru ta ’ provi fuq il- post li komplew jikkonfermaw is- sigurtà ta ’ Duvaxyn WNV u taw prova tal- effikaċja tiegħu fit- tnaqqis tan- numru ta ’ żwiemel viremiċi fejn b’ hekk ikunu qed joffru protezzjoni kontra l- marda.
What benefit has Duvaxyn WNV shown during the studies?
X’ inhu l- benefiċċju ta ’ Dunaxyn WNV li ntwera matul dawn l- istudji?
• The results of the safety studies indicated that the product is safe for horses. • The vaccine has been shown to protect animals from the disease through a reduction of the number of viraemic horses.
• Ir- riżultati tal- istudji dwar is- sigurtà wrew li l- prodott huwa sigur għaż- żwiemel. • Il- vaċċin wera li jipproteġi l- annimali mill- marda permezz ta ’ tnaqqis fin- numru ta ’ żwiemel viremiċi.
What is the risk associated with Duvaxyn WNV?
X’ inhu r- riskju assoċjat ma ’ Duvaxyn WNV?
A small number of animals may show temporary local reactions, in the form of a mild, local swelling at the injection site post vaccination (maximum 1 cm in diameter), that resolve by themselves within 1 to 2 days.
Din titlaq waħedha fi żmien jum jew jumejn.
It is sometimes associated with pain and mild depression.
Din xi kultant tkun assoċjata ma ’ wġigħ u depressjoni ħafifa.
In some cases a higher temperature may occur for up to 2 days.
F’ xi każijiet jista ’ jitla ’ d- deni u jdum sa jumejn l- iktar.
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.
Fil- każ ta ’ injezzjoni aċċidentali fuq il- persuna li tkun qed tagħti l- vaċċin, itlob parir mediku minnufih u uri l- fuljett ta ’ tagħrif jew it- tikketta lit- tabib.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Kemm għandu jgħaddi żmien qabel l- anninal ikun jista ’ jiġi maqtul u l- laħam jintuża mill- bniedem? konsum (perjodu ta ’ rtirar)?
Zero days
0)
What is the time to allow before milk can be taken from the animal for human consumption?
Kemm irid jgħaddi żmien qabel ma jkun jista 'jittieħed ħalib mill- annimal għall- konsum mill- bniedem?
Why has Duvaxyn WNV been approved?
Għaliex ġie approvat Dunavyn WNV?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Duvaxyn WNV outweigh the risks for the treatment of West Nile virus disease in horses and recommended that Duvaxyn WNV be given a marketing authorisation.
Il- Kumitat dwar il- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Duvaxyn WNV huma akbar mir- riskji għat- trattament tal- vajrus West Nile fiż- żwiemel u rrakkomanda li Duvaxyn WNV jingħata awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance can be found in module 6 of this EPAR.
Il- bilanċ bejn il- benefiċċji u r- riskji huwa disponibbli fil- modulu 6 ta ’ dan l- EPAR.
Other information about Duvaxyn WNV:
Tagħrif ieħor dwar Duvaxyn WNV:
The European Commission granted a marketing authorisation valid throughout the European Union, for Duvaxyn WNV to MAH on 21.11.2008.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Duvaxyn WNV lid- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq fi 21. 11. 2008.
Information on the prescription status of this product may be found on the label/ outer package.
It- tagħrif dwar l- istat tal- preskrizzjoni ta 'dan il- prodott jista' jiġi kkonsultat mit- tikketta/ mill- pakkett ta 'barra.
This summary was last updated on 21.11.2008.
Dan is- sommarju ġie aġġornat l- aħħar fi 21. 11. 2008.
Page 2/ 2 ©EMEA 2008
Paġna 2/ 2 ©EMEA 2008
EU Number
Numru ta ’ l - EMEA
Invented Name Strength
Isem kummerċjali
Package size
Daqs tal - Perjodu ta ’ pakkett Tiżmim
Emulsion for injection
Emulsjoni għall - injezzjoni
Polypropylene syringe with latex-free rubber tip
Siringa tal - polypropylene b’ tarf tal- lasktu mingħajr latex