qanastek/EMEA-V3 huggingface dataset:
If necessary, dissect away any fibrous tissue to free the implant.
Jekk ikun hemm bżonn aqta` kull tessut fibruż biex jiġi illiberat l- impjant.
In adult bitches, heat is commonly induced in the first month following the first administration of the implant.
F’ kelbiet adulti, hija komuni li s- saħna tiġi indotta wara l- ewwel xahar li ġie amministrat l- ewwel impjant.
The incidence of induced heat following administration of a repeat treatment to bitches that have not shown signs of oestrus following a previous administration of the product is low (estimated to be 8%).
L- inċidenza ta ’ namra ndotta hija baxxa (stmata li hi 8%) f’ kelbiet li t- trattament ġie ripetut u li ma kellhom l- ebda sinjal ta’ estru fl - ewwel trattament.
The risk of inducing a fertile heat is low in metoestrus (5%).
Ir- riskju li jiġi ndott saħna fertili huwa baxx f’ metoestrus( 5%).
Administration of Gonazon at other stages of the cycle may induce heat that may be fertile.
Amministrazzjoni ta’ Gonazon fi stadi oħra taċ- ċiklu jista` jinduċi namra li tkun fertili.
If a bitch becomes pregnant following induced heat, embryonic resorption or abortion may occur.
Jekk wara s- saħna ndotta, il- kelba tinqabat tqila, l - embriju jista jiġi risorbit jew abbortit.
Therefore, if heat is observed, contact with male dogs should be prevented until all signs of heat (vulvar swelling, bleeding and attractiveness to male dogs) cease.
Għalhekk kull kuntat ma klieb tas- sess maskili għandu jiġi evitat sakemm kull sinjal ta ’ namra (nefħa tal vulva, tnixxija ta’ demm u attrazzjoni lejn klieb maskili) jieqfu.
Induced heat is not observed if treatment is started before puberty.
Saħna ndotta ma ġietx osservata jekk it- trattament jingħata qabel l- puberta.
In addition, the frequency of induced heat is lower in younger bitches than in older bitches.
Barra minn hekk, l - frekwenza ta ’ saħna ndotta hija anqas f’ kelbiet ta eta’ zgħira milli fi klieb ta’ eta ’ akbar.
However, based on field trial data, the incidence of pseudopregnancy in treated bitches is not greater than in control (untreated) bitches.
L- inċidenza ta ’ psewdo tqala f’ kelbat trattati bbażati fuq informazzjoni miġbura, mhux aktar minn kelbiet taħt kontroll (mhux trattati).
SPECIAL STORAGE PRECAUTIONS
TAGĦRIF SPEĊJALI DWAR KIF GĦANDU JINĦAŻEN
Do not use after the expiry date which is stated on the label ‘ EXP’ Do not store above 25°C.
Tużax wara d- data tal- iskadenza kif muriha fuq it- tiketta ’ EXP ’ Taħżinx il- fuq minn 25°C.
The implant may not be retained in a proportion (1.2%) of treated bitches.
L- impjant jista ’ ma jinżammx f’ numru ta’ kelbiet (1. 2%) trattati.
If the implant cannot be palpated in the month following administration, the owner is encouraged to seek veterinary advice as efficacy cannot be ensured in these cases.
Jekk l- impjanti ma jkunx jista jinħass wara xhar li ġie impjantat, is- sid għandu jieħu l- parir tal- veterinarju għax f’ dawn l - każijiet l- effikaċċja tal- prodott mhix garantita.
Following a single administration, return to ovarian activity after implant removal may take longer in bitches treated before puberty (average 255 days, range 36-429 days) than in adult bitches (average 68 days, range 12 to 264 days).
Wara amministrazzjoni waħda, l- ovarji jistgħu jdumu aktar ma jiġu attivi wara li jitneħħa l- impjant f’ kelbiet trattati qabel il- puberta (medja 255 ġranet, perjodu bejn 36- 429 ġranet) milli kelbat adulti (medja 68 ġranet, perjodu bejn 12 - 264 ġranet).
In addition following a repeat treatment, the timing of a return to heat cannot be accurately predicted.
Barra minn hekk, in- nammra ma tistax tiġi akkuratament prevista jekk it- trattament jiġi ripetut.
The use is not recommended during pregnancy and lactation.
L- użu mhux rakkomandat waqt it- tqala u żmien il- ħalib.
Laboratory studies have shown that administration of the product during early pregnancy in the bitch is unlikely to affect that pregnancy (that is, pregnancy will be carried to full term with the birth of viable pups).
Studji fil- laboratorju urew li amministrazzjoni tal- prodott f’ kelbiet fil- bidu tat- tqala, aktarx ma jaffetwawx dik it- tqala (iġifieri, it- tqala tkompli iż - żmien kollu bit- twelid ta’ ġriewi ħajjin).
In the event of accidental self-administration of the implant, seek medical advice immediately and show the package leaflet or the label to the physician.
Evita li tinjettaħ lilek innifsek. F' każ li tinjetta lilek innifsek, fittex tabib mal- ewwel u qis li turih il - pakkett jew il- fuljett ta 'informazzjoni li jkun fih ġewwa.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA 'PRODOTTI MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI
Ask your veterinary surgeon how to dispose of medicines no longer required.
Staqsi lit- tabib veterinarju tiegħek kif tarmi il- mediċini meta ma jkollokx aktar bżonnohom.
These measures should help to protect the environment.
B’ hekk tkun qed tipproteġi l- ambjent.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
DATA TA 'META ĠIET RIVEDUTA DIN IL- KITBA
An individual carton box contains a single disposable injection device, preloaded inside a hypodermic needle covered with a protective cap.
Kaxxa tal- kartun individwali li fiha strument wieħed sterili għall- injezzjoni li jintrema wara l- użu, ikkargat fis- siringa u mgħotti b’ tapp prottetiv.
What is Halocur?
X’ inhu Halocur?
Halocur contains the active substance halofuginone lactate, which is used against parasitic diseases caused by protozoa.
Halocur ikun fih is- sustanza attiva halofuginone lactate, li tintuża kontra l- mardiet parassitiċi kkawżati mill- protożoa.
Halocur is presented as a clear, yellow solution for administration by mouth.
Holavur jiġi bħala soluzzjoni ċara safra, għall- amministrazzjoni orali.
What is Halocur used for?
Għal x’ hiex jintuża Halocur?
Halocur is used in newborn calves to prevent or reduce diarrhoea due to an organism called Cryptosporidium parvum.
Halocur jintuża fil- prevenzjoni u t- tnaqqis tad- dijarea kkawżata minn organiżmu magħruf bħala Cryptosporidium parvum fl- għoġġiela tat- twelid.
This is a parasite belonging to the ‘ protozoa’ family that invades the digestive system causing diarrhoea.
Dan hu parassita li jagħmel parti mill- familja tal - ‘ protożoa ’ li jinvadi s- sistema diġestiva u jikkawża d- dijarea.
Halocur can be used: • to prevent diarrhoea in farms with a history of cryptosporidiosis (infection with Cryptosporidium), when it is given to newborn calves in the first 24 to 48 hours of life, • to reduce diarrhoea, when it is given in the 24 hours after the onset of diarrhoea.
Halocur jista ’ jintuża: • biex jipprevjeni d- dijarea f’ irziezet bi storja ta ’ cryptosporidiosis (infezzjoni bil - Cryptosporidium), meta jingħata f’ għoġġiela tat- twelid fil- perjodu bejn l- ewwel 24 u 48 siegħa ħajja, • biex inaqqas id- dijarea, meta jingħata fl- 24 siegħa ta ’ wara l- bidu tad- dijarea.
In all cases, Halocur is given to the calf by mouth after a feed, not on an empty stomach, once a day for seven consecutive days.
Fil- każijiet kollha, Halocur jingħata lill- għoġol mill- ħalq wara ikla, mhux fuq stonku vojt, darba kuljum, għal sebat ijiem konsekuttivi.
How does Halocur work?
Kif jaħdem Halocur?
The active substance in Halocur, halofuginone lactate, prevents the growth of Cryptosporidium parvum.
Is- sustanza attiva f’ Halocur, halofuginone lactate, ma tħallix lil Cryptosporidium parvum jikber.
It also prevents it from forming oocysts, which are formed at a certain stage in the lifecycle of the parasite and are excreted (shed) in the faeces.
Tipprevjeni wkoll il- formazzjoni ta ’ oocysts, li jiffurmaw f’ ċertu stadju fiċ- ċiklu tal- ħajja tal- parassita u jinħarġu mill- ġisem fl- ippurgar.
This contributes to the spread of the disease to other animals.
Dan jikkontribwixxi għat- tixrid tal- marda fuq annimali oħra.
Clinical signs of Cryptosporidium parvum infection are seen mainly as diarrhoea.
Is - sinjal kliniku ewlieni ta ’ l- infezzjoni bi Cryptosporidium parvum huwa d- dijarea.
The exact way halofuginone works is unknown.
Il- mod eżatt kif jaħdem halofuginone mhux magħruf.
How has Halocur been studied?
Kif ġie studjat Halocur?
A number of field trials were performed involving calves from different farms.
Saru għadd ta ’ studji li fihom ħadu sehem għoġġiela minn irziezet differenti.
In one trial, calves were included from 40 farms.
Fi studju minnhom, ħadu sehem għoġġiela minn 40 razzett.
Treatment with the recommended dose of Halocur orally during 7 consecutive days, in calves aged from 4 to 10 days was shown to reduce diarrhoea compared to placebo.
Intwera li, meta mqabbel ma ’ plaċebo, it- trattament bid- doża rrakkomandata ta ’ Halocur mogħti oralment għal sebat ijiem konsekuttivi jnaqqas id- dijarea.
Another trial of calves aged from 24 to 48 hours demonstrated that Halocur can prevent diarrhoea due to Cryptosporidium parvum compared with placebo.
Fi studju ieħor ta ’ l- għoġġiela ta ’ bejn 24 u 48 siegħa intwera li Halocur jista ’ jipprevjeni d- dijarea kkawżata minn Cryptosporidium parvum meta mqabbel mal- plaċebo.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged These studies compared treatment with Halocur to placebo.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged X’ inhu l- benefiċċju ta ’ Halocur li ntwera f’ dawn l- istudji?
Early treatment in the first 24 to 48 hours after birth was shown to be most beneficial.
Intwera li trattament bikri mogħti bejn 24 u 48 siegħa wara t- twelid hu l- iktar wieħed li jagħmel il- ġid.
What is the risk associated with Halocur?
X’ inhu r- riskju assoċjat ma ’ Halocur?
Symptoms of toxicity may occur if Halocur is administered at twice the recommended dose.
Is- sintomi tat- tossiċità jistgħu jseħħu jekk Halocur jingħata f’ doża doppja għal dik rakkomandata.
Such symptoms can include diarrhoea, visible blood in the faeces, a decline in milk consumption, dehydration, apathy (lack of responsiveness), weakness and collapse.
Sintomi bħal dawn kienu jinkludu d- dijarea, demm fl- ippurgar, tnaqqis fil- konsum tal- ħalib, deidrazzjoni, apatija (tnaqqis fir- rispons), dgħjufija u kollass.
Halocur should not be administered to calves in cases where diarrhoea has been established for more than 24 hours, or to weak animals.
Halocur m’ għandux jingħata lill - għoġġiela f’ każijiet fejn id- dijarea tkun ilha iktar minn 24 siegħa li bdiet u lanqas lil bhejjem dgħajfa.
Halocur should be given after feeding.
Halocur għandu jingħata wara t- tmigħ.
People who handle Halocur repeatedly may develop skin allergies.
Il- persuni li jmissu Halocur ripetutament jistgħu jiżviluppaw allerġiji fil- ġilda.
Users should avoid skin and eye contact with the product and if such contact happens, they should wash the exposed area thoroughly with clean water.
Min jużaha jrid jevita l - l- kuntatt mal- ġilda u mal- għajnejn u jekk ikun hemm dan il- kuntatt, għandhom jaħslu sew il- parti esposta b’ ilma nadif.
If eye irritation persists, medical advice should be sought.
Jekk l- irritazzjoni fil- għajn tippersisti, wieħed għandu jitob parir mediku.
Protective gloves should be worn while handling the product and hands should be washed after use.
Waqt il- kuntatt mal- mediċina għandhom jintlibsu ingwanti u l- idejn għandhom jinħaslu wara l- użu.
Halocur should not enter watercourses as this may be dangerous for fish and other aquatic organisms.
Halocur m’ għandux jidħol fil- kanali ta ’ l- ilma għax jista ’ jkun perikoluż għall- ħut u għal organiżmi oħra ta ’ l- ilma.
Any unused product or waste materials should be disposed of in accordance with local requirements.
Il- fdalijiet mhux użati u l- materjal mormi tal- prodott għandhom jintremew skond ir - rekwiżiti lokali.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Kemm irid jgħaddi żmiem qabel ma ’ l- annimal ikun jista ’ jinqatel u l- laħam tiegħu jintuża għall- konsum mill- bniedem (withdrawal period)?
13 days.
13- il jum.
What is the time to allow before milk can be taken from the animal for human consumption?
Kemm irid jgħaddi żmiem qabel ma jkun jista ’ jittieħed ħalib mill- annimal għall- konsum mill - bniedem?
Not applicable since the product is only to be used in newborn calves.
Mhux applikabbli billi dan il- prodott għandu jintuża biss fl- għoġġiela tat- twelid.
Why has Halocur been approved?
Għaliex ġie approvat Halocur?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Halocur outweigh the risks in the prevention and reduction of diarrhoea due to Cryptosporidium parvum in newborn calves.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Halocur fil- prevenzjoni u t- tnaqqis tad- dijarea kkawżata minn Cryptosporidium parvum fl- għoġġiela tat- twelid jegħelbu r- riskji tiegħu.
They recommended that Halocur be given a marketing authorisation.
Irrakkomandaw li Halocur 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 jinstab fil- modulu 6 ta ’ dan l- EPAR.
Other information about Halocur:
Tagħrif ieħor dwar Halocur:
The European Commission granted a marketing authorisation, valid throughout the European Union for Halocur to Intervet International B. V. on 29 October 1999.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Halocur valida fl- Unjoni Ewropea kollha lil Intervet International B. V. fid- 29 ta ’ Ottubru 1999.
The marketing authorisation was renewed on 29 October 2004.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fif- 29 ta ’ Ottubru 2004.
Information on the prescription status of this product may be found on the label of the bottle.
Informazzjoni dwar l- istejtus tal- preskrizzjoni ta ’ dan il - prodott tista ’ tinstab fuq it- tikketta tal- fliexkun.
This summary was last updated in June 2007.
Dan is- sommarju ġie aġġornat l- aħħar f’ Ġunju 2007.
Target Species
Speċi li fuqhom għandu jintuża l - prodott
0.5 mg/ ml
0. 5mg/ mL
Oral solution
Soluzzjoni likwida li tittie] ed mill -] alq
New-born calves
G] o [[iela li g] adhom jitwieldu
oral use
Li tittiehed mill - ħalq.
HDPE plastic bottle
Flixkun ta ’ 500ml li fih 490ml tal - prodott
Meat and offal:
Flixkun Laħam u ta ’ 500ml Interjur:
13 days
13 il - gurnata
HDPE plastic bottle
Li tittiehed mill - ħalq.
980 ml
Flixkun ta ’ 980 ml 1000ml li fih 980ml tal - prodott.
1000 ml bottle
Flixkun ta ’ 1000ml
HALOCUR 0.5 mg/ ml oral solution for calves
HALOCUR 0. 5mg/ mL ta] lita likwida li tittie] ed mill -] alq g] all- g] o [[iela.
Active substance
Sustanza Attiva/ i:
Halofuginone base (as lactate salt)
Ba\ i ta ’} alofu[ inon (b] ala lactate)
Benzoic acid (E 210) Tartrazine (E 102)
A`idu ben\ oiku (E210) Tartari\ in (E102)
For a full list of excipients, see section 6.1
Għall - lista sħiħa ta ’ sustanzi mhux attivi, ara sezzioni 6. 1
Oral solution.
Soluzzjoni likwida li tittie] ed mill -] alq
New born calves.
G] o [[iela li g] adhom jitwieldu
In new born calves:
G] o [[iela li g] adhom jitwieldu:
• Prevention of diarrhoea due to diagnosed Cryptosporidium parvum, in farms with history of cryptosporidiosis.
• Prevenzjoni kontra dijareja ikkaw\ ata minn Cryptosoridium pavarum, f’ irziezet li g] andhom storja ta ’ kriptosporidjosi.
Administration should start in the first 24 to 48 hours of age. • Reduction of diarrhoea due to diagnosed Cryptosporidium parvum.
Il- kura g] andha tibda fl- ewwel 24- 48 sieg] a wara t- twelid. • Tnaqqis ta ’ in`idenza ta ’ dijareja ikkaw\ ata minn Cryptosoridium pavarum.
Administration should start within 24 hours after the onset of diarrhoea.
Il- kura g] andha tibda fi\ mien 24 sieg] a wara li tkun bdiet id- dijareja.
In both cases, the reduction of oocysts excretion has been demonstrated.
Fi\ -\ ew [ka\ ijiet, tnaqqis fit- tne]] ija tal- oo`isti [iet demonstrata.
Do not use on an empty stomach.
Tu\ ax fuq stonku vojt.
Do not use in case of diarrhoea established for more than 24 hours and in weak animals.
Tu\ ax f’ ka\ ta ’ dijareja li ilha aktar minn 24 sieg] a u f’ annimali dg] ajfa.
2/ 12 4.5 Special precautions for use
4. 5 Twissijiet speċjali g] all- u\ u
Administer after colostrum feeding, or after milk or milk replacer feeding only, using either a syringe or any appropriate device for oral administration.
U\ a siringa jew strument adattat sabiex tamministra fil -] alq.
Do not use on an empty stomach.
Jekk se
For treatment of anorexic calves, the product should be administered in half a litre of an electrolyte solution.
2/ 12 titratta g] o [[iela bi stonku mqalleb, amministra l- prodott ma taħlita ta ’ nofs litru elektrolajts.
The animals should receive enough colostrum according to good breeding practice.
L - annimali g] andhom jing] ataw kolostrum bi\\ ejjed skond pratti`i ta’ trobbija tajba.
To the user: • Repetitive contact with the product may lead to skin allergies. • Avoid skin and eye contact with the product.
Għal min juża il- prodott. • Kuntatt kontinwu jew ripetittiv mal- prodott jista ’ jikkawża allerġiji • Evita kuntatt tal- prodott mal- ġilda jew l- għajnejn.
In case of skin and eye contact wash the exposed area thoroughly with clean water.
F’ każ ta ’ kuntatt mal- ġilda jew l- għajnejn, laħlaħ sewwa bl- ilma.
If an eye irritation persists, seek medical advice. • Wear protective gloves while handling the product. • Wash hands after use.
Jekk l- irritazzjoni fl- għajnejn tipersisti, ara tabib. • Ilbes ingwanti protettivi waqt li qed tuża dan il- prodott. • Aħsel idejk wara li tuża dan il- prodott.
None if used strictly as directed.
Xejn, sakemm il- prodott jintuża strettament kif avżat.
4.9 Amounts to be administered and administration route
4. 9 Do\ a rakkomandata u l- metodu ta ’ amministrazzjoni
For oral use in calves after feeding
IL- prodott g] andu jing] ata lill- g] o [[iela fil -] alq wara l- ikel.
The dosage is:
Id- do\ a hija ta ’:
100 µg of halofuginone base / kg bw / once a day for 7 consecutive days, i. e.
100 mikrogramma ta ’ ba\ i ta ’] alofu[ inone/ kg pi\] aj / darba kuljum g] al sebat ijiem konsekuttivi, i. e.
2 ml of HALOCUR / 10 kg bw / once a day for 7 consecutive days.
2ml ta ’ HALOCUR/ 10kg pi\] aj / darba kuljum g] al sebat ijiem konsekuttivi.
However, in order to make the HALOCUR treatment easier, a simplified dosage scheme is proposed:
Sabiex id- do\ a [[ta ’ HALOCUR ikun e] fef tista ’ tu\ a ’ din il- formola skematika:
• 35 kg < calves ≤ 45 kg:
• 35kg < g] o [[iela ≤ 45kg:
8 ml of HALOCUR once a day during 7 consecutive days • 45 kg < calves < 60 kg:
8 ml HALOCUR darba kuljum g] al sebat ijiem konsekuttivi. • 45kg < g] o [[iela < 60kg:
12 ml of HALOCUR once a day during 7 consecutive days
12 ml HALOCUR darba kuljum g] al sebat ijiem konsekuttivi.
For smaller or higher weights, a precise calculation should be performed (2 ml/ 10 kg).
Jekk l- annimal ji\ en iktar jew inqas wie] ed g] andu ju\ a l- formola ta ’ 2ml/ 10kg.
To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration is necessary.
Sabiex wie] ed jassigura li d- do\ a hija tajba, wie] ed g] andu ju\ a siringa jew strument ie] or adattat g] all - amministrazzjoni fil -] alq.
The consecutive treatment should be done at the same time each day.
Il- kura g] andha ting] ata fl- istess] in kuljum.
Once the first calf has been treated, all the forthcoming new-born calves must be systematically treated as long as the risk for diarrhoea due to C. parvum persists.
Jekk g] o[ ol [ie trattat b’ dan il- prodott, kull [] o[ ol li jitwieled wara irid jibqa ’ ji[ i trattat sakemm il - periklu ta ’ dijareja minn C. parvum jippersisti fir- razzett.
3/ 12 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Do\ a e`` essiva (sintomi, proċeduri ta ’ emerġenza, antidoti) jekk ikun hemm bżonn)
As symptoms of toxicity may occur at twice the therapeutic dose, it is necessary to apply the recommended dosage strictly.
Min] abba li sintomi ta ’ tossi`ita ’ jibdew jidhru meta ting] ata do\ a terapewtika doppja, huwa ne`essarju li wie] ed jamministra l- prodott strettament kif rakkomandat.
Symptoms of toxicity include diarrhoea, visible blood in faeces, decline in milk consumption, dehydration, apathy and prostration.
Sintomi ta ’ tossi`ita ’ jinkludu: dijareja, demm fil -] mie [, tnaqqis fl- aptit, l- annimal jixxotta, telqa u g] ejja.
Should clinical signs of overdosing occur the treatment must be stopped immediately and the animal fed unmedicated milk or milk replacer.
Jekk ikun hemm dawn is- sintomi wie] ed g] andu jwaqqaf il- kura u l- annimal jing] ata] alib jew sostitut tal -] alib.
Rehydration may be necessary.
Jista ’ wkoll ikun hemm b\ onn li l- annimali ji[ i kkurat g] ad- di\ idrazzjoni.
4.11 Withdrawal period
3/ 12 4. 11 Perjodu ta ’ Tiżmim
13 days.
Laħam u Interjur: 13 - il ġurnata
Quinazolinone derivate, ATCvet code:
Derivattiv ta ’ Quinazolone, Kodici ATĊ veterinarja:
The active substance, Halofuginone, is an antiprotozoal agent of the quinazolinone derivatives group (nitrogenous polyheterocycles).
Is- sustanza attiva} alofun[ inon hija a[ ent anti- proto\ oiku li [ej mill- grupp tal- Quinazolinone (nitrogenous polyheterocycles).
Halofuginone lactate (RU 38788) is a salt whose antiprotozoal properties and efficacy against Cryptosporidium parvum have been demonstrated both in in vitro conditions and in artificial and natural infections.
Halofunginone lactate (RU38788) hija kimika li [iet murija li g] andha l- effett li toqtol il- proto\ oi tat- tip Cryptosoridium parvum kemm in vitro, kif ukoll f’ infezzjonijiet artifi`jali u naturali. Is- sustanza g] andha effett li twaqqaf it- tkabbir tal- kriptosporidja parvum.
The compound has a cryptosporidiostatic effect on Cryptosporidium parvum.
L- aktar li huwa effettiv huwa fl- istadju liberu tal- parassita (sporozojte, merozojte).
The concentrations to inhibit 50% and 90% of the parasites, in an in vitro test system, are IC50 < 0.1 µ g/ ml and IC90 of 4.5 µg/ ml respectively.
Il- kon`entrazzjoni sabiex tinpedixxi 50% u 90% tal- parassiti f’ testijiet li saru in vitro huwa ta ’ IC50 < 0. 1 mikrogrammi/ ml u IC90 ta ’ 4. 5 mikrogrammi/ ml rispettivament.
The bioavailability of the drug in the calf, following single oral administration, is about 80%.
Il- bio- avilibilita tal- ingredjent attiv wara do\ a wa] da fl- g] o [[iela hija ta’ madwar 80%.
The time necessary to obtain the maximum concentration Tmax is 11 hours.
L- g] ola kon`entrazzjoni tintla] aq (Tmax) fi 11- il sieg] a.
The maximum concentration in plasma Cmax is 4 ng/ ml.
L- g] ola kon`entrazzjoni fil- plasma (Cmax) hija ta ’ 4 nanogrammi/ millilitru.
The apparent volume of distribution is 10 l/ kg.
Il- volum apparenti ta’ distrubuzzjoni huwa ta ’ 10 litri/ kilogramma.
Unchanged Halofuginone is the major component in the tissues.
Il - kon`entrazzjoni ta ’] alofu[ inon fil- plasma wara do\ a amministrata ripetutament mill -] alq hija simili g] all- profil farmokinetiku ta ’ do\ a wa] da.} alofu[ inone mhux modifikat, huwa l- akbar komponent li wie] ed isib fit- tessuti.
Highest values have been found in the liver and the kidney.
L- g] ola livelli tal- prodott instabu fil- fwied u l- kliewi.
The product is mainly excreted in the urine.
Il- prodott ji[ i mneħħi mill - [isem l- aktar fl- urina.
The terminal elimination half-life is 11.7 hours after IV administration and 30.84 hours after single oral administration.
Il -] in sabiex nofs il- prodott ikun eliminat huwa ta ’ 11. 7 sieg] at wara somministrazzjoni fil- vina u ta ’ 30. 84 sieg] at meta jing] ata f’ do\ a wa] da fil -] alq.
Benzoic acid (E 210) Tartrazine (E 102)
Aċidu Benżoiku (E210) Tartariżin (E102)
6.2 Incompatibilities
1. 00mg/ ml 0. 03mg/ ml
None known.
6. 2 Inkompatibilitajiet
6.3 Shelf life
M' hemm xejn magħruf
3 years.
6. 3 Żmien ta 'kemm il- prodott idum tajjeb
Shelf-life after first opening the container:
3 snin Żmien li l- prodott jibqa ’ tajjeb wara li jkun tneħħa mill- ewwel ippakkjar:
6 months.
6 xhur
4/ 12 6.4 Special precautions for storage
6. 4 Tagħrif speċjali dwar kif għandu jinħażen
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali veterinarju m’ għandu bżonn ta ’ l- ebda kondizzjoni speċjali sabiex jinħażen.
High-density polyethylene portable bottle of 500 ml containing 490 ml of the oral solution.
Flixken tal- poli- etilin ta ’ densita għolja tal- 500ml li jkun fihom 490 ml tal- prodott.
High-density polyethylene portable bottle of 1000 ml containing 980 ml of the oral solution.
Flixken tal- poli- etilin ta ’ densita għolja tal- 1000ml li jkun fihom 980ml tal- prodott.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
4/ 12 6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użata jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
HALOCUR should not enter watercourses, as this may be dangerous for fish and other aquatic organisms.
HALOCUR ma għandu qatt jitħalla jmur man- nixxiegħat tal- ilma minħabba li jista ’ jkun ta 'periklu għall - ħut jew ħlejqiet oħra akwatici.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the 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.
Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Intervet International B. V Wim de Korverstraat 35 5831 AN Boxmeer Olanda
29-Oct-04
29 ta ’ Ottubru
5/ 12 ANNEX II
5/ 12 ANNESS II
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIOLOĠIKA (/ BIOLOĠIĊI) ATTIVA( I) U > SID/ S- SIDIEN TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
Name and address of the manufacturer(s) responsible for batch release
MANIFATTURA( I) TAS- SUSTANZA( I) BIOLOĠIKA( ĊI) ATTIVA( I) U > SID (/ S - SIDIEN TA ’) L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL - HRUĠ TAL- LOTT
Intervet Productions SA Rue de Lyons F-27460 Igoville France
Intervet Productions SA Rue de Lyons F- 27460 Igoville France
In accordance with Council Regulation (EEC) No 2377/ 90, as amended and in accordance with Article 34.4b of Regulation (EEC) No 726/ 2004 of 31 March 2004. Halofuginone is included in Annex I of Council Regulation (EEC) No 2377/ 90 in accordance with the following table:
skond ir- Regoalment tal- Kunsill (KE) Nru 2377/ 90, kif emendat u skond l- Artikolu 34. 4b tar - Regolament (KE) Nru 726/ 2004 tal- 31 ta ’ Marzu 2004.
Pharmacologically active
Ħalofuġinone huwa inklużi fl- Anness I < Anness III > tar- Regolament tal- Kunsill (KE) Nru 2377/ 90 skond it- tabella li jmiss:
substance
Sustanzi attivi farmakoloġiċi
Marker residue
Residwi
Animal species
Speci
MRLs (*)
MRL s
Target tissues
Organu
30 µg/ kg 30 µg/ kg
30mikrogramma/ kilogramma
Liver Kidney
Fwied
Halofuginone
ĦALOFUĠINON
Bovine
BOVINI
10 µg/ kg 25 µg/ kg
30mikrogramma/ kilogramma 30mikrogramma/ kilogramma 30mikrogramma/ kilogramma
Muscle Fat
Kliewi Muskoli Xaħam
7/ 12 ANNEX III
7/ 12 ANNESS III
9/ 12 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
9/ 12 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
500 ml bottle/ 1000 ml bottle
Flixkien ta ’ 500ml/ 1000ml
HALOCUR 0.5 mg/ ml oral solution for calves
HALOCUR 0. 5mg/ ml ta] lita likwida li tittie] ed mill -] alq g] all- g] o [[iela.
Halofuginone base (as lactate salt) Benzoic acid (E 210) Tartrazine (E 102)
Ba\ i ta ’} alofu[ inon (b] ala lactate) A`idu ben\ oiku (E210) Tartari\ in (E102)
0.50 mg/ ml 1.00 mg/ ml 0.03 mg/ ml
0. 50 mg/ ml 1. 00 mg/ ml 0. 03 mg/ ml
500 ml bottle containing 490 ml of oral solution / 1000 ml bottle containing 980 ml of oral solution
Flixkun ta ’ 500ml li fih 490ml tal- prodott / Flixkun ta ’ 1000ml li fih 980ml tal- prodott.
New born calves
G] o [[iela li g] adhom jitwieldu
In both cases, the reduction of oocysts excretion has been demonstrated.
Fi\ -\ ew [ka\ ijiet, tnaqqis fit- tne]] ija tal- uo`isti [iet demonstrata.
For oral use in calves after feeding:
IL- prodott g] andu jing] ata lill- g] o [[iela fil -] alq wara l- ikel.
8 ml of HALOCUR once a day for 7 consecutive days • 45 kg < calves < 60 kg:
8 ml HALOCUR darba kuljum g] al sebat ijiem konsekuttivi. • 45kg < g] o [[iela < 60kg:
12 ml of HALOCUR once a day for 7 consecutive days
12 ml HALOCUR darba kuljum g] al sebat ijiem konsekuttivi.
10/ 12 To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration is necessary.
10/ 12 Sabiex wie] ed jassigura li d- do\ a hija tajba, wie] ed g] andu ju\ a siringa jew strument ie] or adattat g] all - amministrazzjoni fil -] alq.
Once the first calf has been treated, all the forthcoming new born calves must be systematically treated as long as the risk for diarrhoea due to C. parvum persists.
Jekk g] o[ ol [ie trattat b’ dan il- prodott, kull [] o[ ol li jitwieled wara irid jibqa ’ ji[ i trattat sakemm il - periklu ta ’ dijareja minn C. parvum jippersisti fir- razzett.
13 days.
Laħam u Interjur: 13 il - gurnata
For treatment of anorexic calves, the product should be administered in half of a litre of an electrolyte solution.
Jekk se titratta g] o [[iela anoressi`i, amministra l- prodott ma tahlita ta ’ nofs litru electrolytes.
The animals should receive enough colostrum according to good breeding practice.
L - annimali g] andhom jing] ataw kolostrum bi\\ ejjed skond pratti`i tat- trobbija tajba.
Overdose:
Doża eċċesiva:
Symptoms of toxicity include diarrhoea, visible blood in faeces, decline in milk consumption, dehydration, apathy and prostration.
Sintomi ta ’ tossi`ita ’ jinkludu: dijareja, demm fil -] mie [, tnaqqis fl- aptit, l- annimali jixxotta, telqa u g] ejja.
Should clinical signs of overdosing occur the treatment must be stopped immediately and the animal fed unmedicated milk or milk replacer.
Jekk ikun hemm dawn is- sintomi wie] ed g] andu jwaqqaf il- kura u l- annimali jing] ata] alib jew sostitut tal -] alib.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: • Repetitive contact with the product may lead to skin allergies. • Avoid skin and eye contact with the product.
Għal min juża il- prodott. • Kuntatt kontinwu jew ripetittiv mal- prodott jista ’ jikkawża allergiji • Evita kuntatt tal- prodott mal- ġilda jew l- għajnejn.
If an eye irritation persists, seek medical advice. • Wear protective gloves while handling the product. • Wash hands after use.
Jekk l- irritazzjoni fl- għajnejn tipersisti, ara tabib. • Ilbes ingwanti protetivi waqt li qed tuża dan il- prodott. • Aħsel idejk wara li tuża dan il- prodott.
EXP: month/ year Once broached, use within 6 months.
Jiskadi {xahar / sena} La darba jinfetaħ uża fi żmien 6 xhur
This medicinal product does not required any special storage conditions.
KONDIZZJONIJIET SPEĊJALI DWAR KIF GĦANDU JINĦAŻEN
HALOCUR should not enter watercourses, as this may be dangerous for fish and other aquatic organisms.
Dan il- prodott mediċinali veterinarju m’ għandux bżonn ta ’ l- ebda kondizzjoni speċjali sabiex jinħażen.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
HALOCUR ma għandu qatt jitħalla jmur man- nixxiegħat tal- ilma minħabba li jista ’ jkun ta 'periklu għall - ħut jew ħlejqiet oħra akwatici.
To be supplied only on veterinary prescription.
Għal Trattament ta ’ l- Annimali Biss - Sabiex jiġu mogħtija biss bi preskrizzjoni veterinarja.
Wim de Körverstraat 35 NL-5831 AN Boxmeer The Netherlands
Wim de Korverstraat 35 5831 AN Boxmeer Olanda
EU/ 2/ 99/ 013/ 001-002
EU/ 2/ 99/ 013/ 001- 0020
< Batch > < Lot > < BN > number.
< Lott > < lott > < Numru tal- lott > {numru}
This document is a summary of the European Public Assessment Report.
Dan id- dokument huwa sommarju tar- Rapport tal- Valutazzjoni Pubblika Ewropew..
What is Ibaflin?
X’ inhu Ibaflin?
Ibaflin contains ibafloxacin, which belongs to a class of medicines having an antibiotic action.
Ibaflin fih ibafloxacin, li jappartieni għal klassi ta ’ mediċini li għandhom azzjoni antibijotika.
Ibaflin is available as tablets (30, 150, 300 and 900 mg) and as oral gels (3 and 7.5%).
Ibaflin jiġi bħala pilloli (30, 150, 300 u 900 mg) u bħala ġellijiet li jittieħdu mill- ħalq (3 u 7. 5%).
What is Ibaflin used for?
Għalxiex jintuża Ibaflin?
Ibaflin is used to treat the infections in dogs and cats: • skin infections, including shallow and deep ‘ pyoderma’, infected wounds and abscesses caused by bacteria such as Staphylococci, E. coli, Proteus species and Pasteurella species, • upper respiratory tract infections caused by Staphylococci, E. coli and Klebsiella species.
Ibaflin jintuża biex jittratta l- infezzjonijiet fil- klieb u l- qtates: • Infezzjonijiet tal- ġilda, inkluż ‘ pyoderma ’ fil- wiċċ u fonda, feriti infettati u axxesi kkawżati minn baterji bħall- ispeċi Staphylococci, E. coli, Proteuss u l- ispeċi Pasteurella, • Infezzjonijiet fil- parti ta ’ fuq tal- passaġġ respiratorju ikkawżati mill- ispeċi Staphylococci, E. coli u Klebsiella.
It is also used in dogs to treat acute (short-lived), uncomplicated infections of the urinary tract caused by Staphylococci, Proteus species, Enterobacter species, E. coli and Klebsiella species.
Jintuża wkoll fi klieb biex jittratta infezzjonijiet akuti (li jdumu qasir żmien), mhux ikkumplikati tal- passaġġ urinarju ikkawżati mill- ispeċi Staphylococci, l- ispeċi Proteus, l- ispeċi Enterobacter, E. coli u Klebsiella.
Ibaflin is given by mouth.
Ibaflin jingħata fil- ħalq.
Dogs are treated using the tablets, except for skin infection, where in addition to the tablets either strengths of the oral gel may be used.
Il- klieb huma ttrattati permezz ta ’ pilloli, għajr għal infezzjoni tal- ġilda, fejn, apparti l- pilloli tista ’ tintuża qawwa jew oħra tal- ġel orali.
Cats are treated using the 3% oral gel.
Il- qtates huma ttrattati permezz ta ’ 3% ġel orali.
The dose and duration of treatment depend on the nature and severity of the infection, the weight and species of the animal being treated, and the animal’ s response to treatment.
Id- doża u t- tul tat- trattament jiddependu fuq in- natura u s- severità ta ’ l - infezzjoni, il- piż u l- ispeċi ta ’ l- annimal li jkun qiegħed jiġi trattat, u r- rispons ta ’ l- annimal għat- trattatment.
The standard dose is 15 mg per kilogram body weight once a day for the length of time determined by your veterinarian.
Id- doża standard hija 15 mg għal kull kilogramm tal- piż tal- ġisem darba kuljum għat- tul ta ’ żmien stabbilit mill- veterinarju tiegħek.
For more information, see the Package Leaflet.
Għal aktar informazzjoni ara l - Fuljett ta ’ Tagħrif.
How does Ibaflin work?
Kif jaħdem Ibaflin?
Ibafloxacin, is an antibiotic belonging to the class ‘ fluoroquinolones’.
Ibafloxacin, huwa antibijotiku li jappartieni għall- klassi ta ’ ‘ fluoroquinolones ’.
It works by blocking an enzyme called ‘ DNA gyrase’, which is important in allowing bacteria to make copies of their DNA.
Jaħdem billi jimblokka enzim imsejjaħ ‘ DNA gyrase ’, li huwa importanti sabiex il- batterji jitħallew jagħmlu kopji tad- DNA tagħhom.
This enzyme is only found in bacterial cells, and does not have a similar function in animal cells.
Dan l- enzim jinstab biss f’ ċelloli batterjali, u ma għandux funzjoni simili f’ ċelloli ta ’ l- annimali.
By blocking DNA gyrase, ibafloxacin prevents the bacteria from making DNA and stops them making proteins and growing, resulting in their death.
Billi jimblokka DNA gyrase, ibafloxacin jimpedixxi l- batterji milli jagħmlu DNA u jwaqqafhom milli jagħmlu proteini u milli jikbru, u dan iwassal għall- mewt tagħhom.
A strain which is resistant to one type of fluoroquinolone will also be resistant to other members of the class of fluoroquinolones.
Razza li hija reżistenti għal tip ta ’ fluoroquinolone tkun reżistenti wkoll għal membri oħrajn tal- klassi ta ’ fluoroquinolones.
The use of ibafloxacin may result in an increase in the prevalence of resistant strains in the target species although this risk is likely to be less of a concern due to the treatment of individual animals with this product.
L- użu ta ’ ibafloxacin jista ’ jirriżulta f’ żjieda fil -
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 46 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Ibaflin been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 46 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged prevalenza ta ’ razez reżistenti fl- ispeċi fil- mira għalkemm dan ir- riskju huwa mistenni li jkun inqas ta ’ tħassib minħabba t- trattament ta ’ annimali individwali b’ dan il- prodott.
Ibaflin tablets have been studied in dogs, looking at their effectiveness in treating skin, urinary tract and respiratory tract infections.
Il- pilloli ta ’ Ibaflin ġew studjati fuq klieb, b’ mod partikolari ġiet studjata l- effettività tagħhom fit- trattament ta ’ l- infezzjonijiet tal- ġilda, tal- passaġġ urinarju u tal- passaġġ respiratorju.
The oral gel has been studied in cats looking at skin, respiratory tract and urinary tract infections.
Il- ġel orali ġie studjat fuq il- qtates billi ġew osservati infezzjonijiet tal- ġilda, tal- passaġġ respiratorju u tal- passaġġ urinarju.
In these studies, the effects of Ibaflin were compared with those of other antibiotics (marbofloxacin, enrofloxacin or amoxicillin/ clavulanic acid).
F’ dawn l- istudji, l- effetti ta ’ Ibaflin ġew imqabbla ma ’ dawk ta ’ antibijotiċi oħrajn (marbofloxacin, enrofloxacin jew amoxicillin/ clavulanic acid).
From data of two different clinical trials, comparable efficacy was shown between the Ibaflin gel formulations and a positive control to support the claims for skin (soft tissue infections – wounds, abscesses) and upper respiratory tract infections in cats for the oral gel formulations.
Mit- tagħrif miġbur minn żewġ provi kliniċi differenti, intweriet effikaċja komparabbli bejn il - formulazzjonijiet tal- ġel ta ’ Ibaflin u kontroll pożittiv biex jiġu appoġġjati l- klejms għal infezzjonijiet tal- ġilda (infezzjonijiet tat- tessut artab – feriti, axxesi) u infezzjonijiet tal- parti ta ’ fuq tal- passaġġ respiratorju fi qtates għall- formolazzjonijiet tal- ġel orali.
The indication for treatment of urinary infections in cats was not accepted.
L- indikazzjoni għat- trattament ta ’ l- infezzjonijiet urinarji fi qtates ma ġietx aċċettata.
Ibaflin oral gel is indicated in dogs for the treatment of skin infections (pyoderma – superficial and deep, wounds, abscesses).
Il- ġel orali Ibaflin huwa indikat sabiex jintuża fuq klieb għat- trattament ta ’ infezzjonijiet tal- ġilda (pyoderma – feriti fil- wiċċ u fondi, axxesi).
Comparable efficacy of the gel formulation to the tablet formulation was shown for dogs in a clinical trial.
Fi prova klinika, għall- klieb, intweriet effikaċja komparabbli tal- formolazzjoni tal- ġel għal dik tal- formolazzjoni tal- pillola.
What benefit has Ibaflin shown during the studies?
X’ benefiċċju wera Ibaflin matul l- istudji?
Ibaflin tablets were at least as effective as the comparator antibiotics in treating skin, urinary tract and upper tract respiratory infections in dogs.
Il- pilloli ta ’ Ibaflin kienu effettivi għallinqas daqs l- antibijotiċi ta ’ tqabbil fit- trattament ta ’ infezzjonijiet tal- ġilda, tal- passaġġ urinarju u tal- parti ta ’ fuq tal- passaġġ respiratorju fil- klieb.
The tablets and oral gel were of comparable effectiveness in treating skin infections in dogs.
Il- pilloli u l- ġel orali kienu ta ’ effettività komparabbli fit- trattament ta ’ infezzjonijiet tal- ġilda fil- klieb.
The oral gel was also at least as effective as the comparator antibiotic (amoxicillin/ clavulanic acid) in treating skin and upper respiratory tract infections in cats.
Il- ġel orali kien ukoll għallinqas effettiv daqs l- antibijotiku ta ’ tqabbil (amoxicillin/ clavulanic acid) fit- trattament ta ’ infezzjonijiet tal- ġilda u tal- parti ta ’ fuq tal- passaġġ respiratorju fil - qtates.
However, the results were insufficient to support the use of Ibaflin in the treatment of urinary tract infections in cats.
Madankollu, ir- riżultati ma kinux suffiċjenti biex jappoġġjaw l- użu ta ’ Ibaflin fit - trattament ta ’ l- infezzjonijiet tal- passaġġ urinarju fil- qtates.
What are the side-effects associated with Ibaflin?
X’ inhu r- riskju assoċjat ma ’ Ibaflin?
Diarrhoea, soft faeces, vomiting, dullness (lack of responsiveness) and anorexia (loss of appetite) occur with low frequency in dogs and cats given Ibaflin.
Dijarrea, ippurgar maħlul, rimettar, nuqqas ta ’ rispons u anoreksja (nuqqas ta ’ aptit) iseħħu bi frekwenza baxxa fi klieb u qtates mogħtija Ibaflin.
Salivation can also occur with the oral gel.
Bil- ġel orali jista ’ jiġi osservat tbeżliq.
These effects are mild and temporary.
Dawn l- effetti huma ħfief u temporanji.
People who are hypersensitive (allergic) to quinolones should avoid any contact with Ibaflin.
Nies li huma sensittivi żżejjed (allerġiċi) għal quinolones għandhom jevitaw kwalunkwe kuntatt ma ’ Ibaflin.
Medical advice should be sought if the tablets are swallowed accidentally, particularly by a child.
Wieħed għandu jfittex parir mediku jekk il- pilloli jinbelgħu aċċidentalment, b’ mod partikolari minn tifel/ tifla.
Why has Ibaflin been approved?
Għaliex ġie approvat Ibaflin?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Ibaflin exceed the risks for the treatment of skin infections, and respiratory tract infections (upper tract) in dogs and cats, and acute, uncomplicated urinary tract infections in dogs, and recommended that Ibaflin be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Ibaflin jisbqu r- riskji għat- trattament ta ’ infezzjonijiet tal- ġilda, u infezzjonijiet fil- passaġġ respiratorju (parti ta ’ fuq) fi klieb u qtates, u infezzjonijiet akuti mhux ikkumplikati fil- passaġġ urinarju, u rrakkomanda li Ibaflin jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Ibaflin:
Tagħrif ieħor dwar Ibaflin:
The European Commission granted a marketing authorisation valid throughout the European Union for Ibaflin to Intervet International B. V. on 13 June 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Ibaflin lil Intervet International B. V. fit- 13 ta ’ Ġunju 2000.
The marketing authorisation was renewed on 13 June 2005.
L - awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 13 ta ’ Ġunju 2005.
EMEA/ V/ C/ 051
EMEA/ CVMP/ numru tal- prodott
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Dan id- dokument ma jistax jissostitwixxi diskussjoni ras imb’ ras mal- veterinarju tiegħek. Jekk inti teħtieġ aktar informazzjoni dwar il - kondizzjoni medika jew dwar it- trattament ta ’ l- annimal tiegħek, jekk jogħġbok ikkuntattja lill - veterinarju tiegħek.
What is Ibraxion?
X’ inhu Ibraxion?
Ibraxion is an emulsion for injection.
Ibraxion huwa emulsjoni għal injezzjoni.
Each 2 ml dose of Ibraxion contains the active substance inactivated gene deleted Infectious Bovine Rhinotracheitis (IBR) virus.
Kull doża ta ’ 2 ml ta ’ Ibraxion fiha s- sustanza attiva virus inattivat b’ ġene mħassra ta ’ Infectious Bovine Rhinotracheitis (IBR).
This deletion allows to differentiate vaccinated animals from infected animals allowing a better management of the disease.
Dan it- tħassir jippermetti li ssir differenza bejn annimali mlaqqmin u annimali infettati biex b’ hekk ikun hemm ġestjoni aħjar tal - marda.
What is Ibraxion used for?
Għal x’ hiex jintuża Ibraxion?
Ibraxion is used to immunise cattle to reduce the clinical signs of IBR and reduce field virus excretion (virus that is passed out of the animal).
Ibraxion jintuża għat- tilqim ta ’ baqar biex jitnaqqsu s- sinjali kliniċi ta ’ IBR u jitnaqqas il- ħruġ tal - virus fil- qasam (virus li joħroġ barra mill- annimal).
Ibraxion is shaken before use and injected subcutaneously (under the skin) into the neck at the front of the shoulder.
Ibraxion għandu jitħawwad qabel l- użu u għandu jiġi injettat taħt il- ġilda fl- għonq fil- parti ta ’ quddiem ta ’ l- ispalla.
Two injections are given 21 days apart in animals from the age of 2 weeks where there are no antibodies against IBR virus from the mother.
Jingħataw żewġ injezzjonijiet 21 ġurnata ’ l bogħod minn xulxin f’ annimali minn ġimagħtejn ’ il fuq li ma għandhomx anti- korpi kontra l- virus IBR mill- omm.
If there are antibodies, the vaccine should be given from the age of 3 months.
Jekk hemm anti- korpi, il - vaċċin għandu jingħata mill- età ta ’ 3 xhur.
To revaccinate, a booster injection should be given at 6-month intervals.
Għal vaċċinazzjoni mill- ġdid, għandha tingħata injezzjoni booster f’ intervalli ta ’ 6 xhur.
Immunity starts after 14 days and lasts for 6 months.
L- immunità tibda wara 14- il ġurnata u ddum għal 6 xhur.
How does Ibraxion work?
Kif jaħdem Ibraxion?
Ibraxion contains a gene deleted IBR virus, which is inactivated.
Ibraxion fih virus IBR b’ ġene mħassra, li huwa inattivat.
When injected, this exposure helps the calf’ s immune system to recognise and fight the IBR virus.
Meta injettat, din l- espożizzjoni tgħin lis - sistema immuni ta ’ l- għoġol biex tagħraf u tiġġieled il- virus ta ’ l- IBR.
When exposed to IBR virus later in life, the calf will either not become infected or have a much less serious infection.
Meta espost għall- virus ta ’ l - IBR aktar tard matul il- ħajja, l- għoġol jew ma jibqax infettat jew ikollu infezzjoni ħafna inqas serja.
Ibraxion is also intended to reduce the spread of the IBR virus by reducing the amount of virus excreted by the animals.
Ibraxion huwa maħsub ukoll sabiex inaqqas il- firxa tal- virus ta ’ l- IBR billi jnaqqas l- ammont tal- virus li joħroġ mill- annimali.
How has the effectiveness of Ibraxion been studied?
Kif ġiet studjata l- effikaċja ta ’ Ibraxion?
Ibraxion has been studied using the recommended dosing in all categories and age groups of animals.
Ibraxion ġie studjat bl- użu tad- doża rakkomandata fil- kategoriji u l- gruppi ta ’ età kollha ta ’ l- annimali.
The effect of antibodies passed on by the mother was also investigated.
L- effett ta ’ anti- korpi li jgħaddu mill- omm ġie investigat ukoll.
The protection given by Ibraxion was measured by the reduction of clinical signs of IBR after the virus was introduced to the cattle.
Il- protezzjoni mogħtija minn Ibraxion ġiet imkejla bit- tnaqqis ta ’ sinjali kliniċi ta ’ l- IBR wara li l- virus ġie introdott fil- baqar.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Ibraxion shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged X’ benefiċċju wera Ibraxion waqt l- istudji?
The results of the trials showed that vaccination by Ibraxion of calves either not less than 3 to 4 months of age (if they have antibodies to IBR that have been passed on from their mother) or from 2-week of age (if they have no maternal antibodies). provided protection from IBR for six months.
Ir- riżultati tal- provi wrew li t- tilqima b’ Ibraxion fuq għoġġiela li, jew ma għandhomx inqas minn 3 sa 4 xhur (jekk għandhom anti- korpi ta ’ IBR li għaddew minn ommhom), jew għandhom età ta ’ ġimagħtejn (jekk m’ għandhomx anti- korpi materni), ipprovdiet protezzjoni mill- IBR għal sitt xhur.
The studies also confirmed the effect of a booster injection at 15 months after the first vaccination (the booster for Ibrax is recommended every 6 months).
L - istudji jikkonfermaw ukoll l- effett ta ’ injezzjoni booster fi 15- il xahar wara l- ewwel tilqima (il- booster għal Ibrax hija rakkomandata kull sitt xhur).