qanastek/EMEA-V3 huggingface dataset:
On the first day of treatment, it can be given by injection under the skin before switching to the tablets; • in cattle, Dicural is used to treat infections affecting the lungs and breathing (shipping fever and calf pneumonia).
Fl- ewwel jum tat- trattament, jista ’ jingħata b’ injezzjoni taħt il- ġilda qabel ma jinqalbu fuq il- pilloli; • fl- ifrat, Dicural jintuża fit- trattament ta ’ infezzjonijiet li jaffettwaw il- pulmuni u n- nifs (shipping fever u pnewmonja fl- għoġliet).
It is only used in calves and young cattle.
Jintuża biss f’ għoġliet u ifrat żgħar.
Dicural is given once a day for up to five days as an injection under the skin.
Dicural jingħata darba kuljum għal ħamest ijiem bħala injezzjoni taħt il- ġilda.
For full details, see the Summary of Product Characteristics (SPC, also part of the EPAR).
Għad- dettalji kollha, ara s- Sommarju tal- Karatteristiċi tal- Prodott (SPC, ukoll parti mill- EPAR).
How does Dicural work?
Kif jaħdem Dicural?
The active substance in Dicural, difloxacin, belongs to a group of antibiotics called ‘ fluoroquinolones’.
Is- sustanza attiva f’ Dicural, difloxacin, tagħmel parti minn grupp ta ’ antibijotiċi magħrufin bħala ‘ fluoroquinolones ’.
Difloxacin works by blocking an enzyme called ‘ DNA gyrase’, which is important in allowing bacteria to make copies of their DNA.
Difloxacin jaħdem billi jimblokka enzim magħruf bħala ‘ DNA gyrase ’, li hu importanti għax jippermetti lill- batterji jagħmlu kopji tad- DNA tagħhom.
By blocking the production of DNA, difloxacin stops the bacteria that are causing an infection from growing and multiplying.
Meta jimblokka l- produzzjoni tad- DNA, difloxacin iwaqqaf il- batterji li jkunu qed jikkawżaw infezzjoni milli jikbru u jimmultiplikaw.
The full list of bacteria against which Dicural is active can be found in the SPC.
Il- lista sħiħa ta ’ batterji li Dicural huwa attiv kontrihom tista ’ tinstab fl- SPC.
How has Dicural been studied?
Kif ġie studjat Dicural?
In chickens and turkeys, nine main trials have been carried out in birds with respiratory system infections.
Fit- tiġieġ u fid- dundjani, saru disa ’ provi ewlenin fl- għasafar b’ injezzjoni fis- sistema respiratorja.
In dogs, four main trials looked at the effects of Dicural in treating bladder infections.
Waħda minn dawn il- provi qabblet għasafar ittrattati b’ Dirural ma ’ għasafar mhux ittrattati, u oħra qabblet Dicural ma ’ enrofloxacin (fluoroquinolone veterinarju ieħor).
Reproduction is authorised provided the source is acknowledged. at its effects in treating pyoderma: two compared it with enrofloxacin and one compared it with amoxicillin and clavulanic acid.
Fil- klieb, erba ’ provi ewlenin ħarsu lejn l- effetti ta ’ Dicural fit- trattament ta ’ infezzjonijiet fil - borża tal- awrina.
In cattle, seven main studies were carried out.
Fl- ifrat, saru seba ’ studji ewlenin.
All seven studies compared Dicural with enrofloxacin in calves.
Is- seba ’ studji qabblu Dicural ma ’ enrofloxacin fl- ifrat.
What benefit has Dicural shown during the studies?
X’ inhu l- benefiċċju li wera Dicural matul dawn l- istudji?
In all species, Dicural was effective in reducing the number of infected animals or reducing the severity of infection.
Fl- ispeċi kollha, Dicural kien effettiv fit- tnaqqis fin- numru ta ’ annimali infettati jew fit - tnaqqis tas- severità tal- infezzjoni.
Dicural was as effective as or slightly more effective than the comparator antibiotics.
Dicural kien effettiv daqs jew ftit iktar mill- antibijotiċi li tqabbel miegħu.
What is the risk associated with Dicural?
X’ inhu r- riskju assoċjat ma ’ Dicural?
In chickens and turkeys, no side effects from Dicural are known.
Fit- tiġieġ u fid- dundjani, ma huma magħrufa l- ebda effetti sekondarji minn Dicural.
However, since no studies have been performed in lame birds, Dicural must not be used in birds with existing leg weakness or osteoporosis (brittle bones).
Madankollu, billi ma saru l- ebda studji f’ għasafar zopop, Dicural m’ għandux jintuża f’ għasafar li diġà jkollhom dgħjufija fir- riġlejn jew osteoporożi (għadam fraġli).
In dogs, side effects from Dicural are rare, but include loss of appetite, vomiting, diarrhoea and anal irritation.
Fil- klieb, l- effetti sekondarji minn Dicural huma rari, iżda jinkludu telf ta ’ aptit, remettar, dijarea u irritazzjoni anali.
These tend to disappear within one or two days and do not require additional treatment.
Dawn ġeneralment imorru fi żmien jum jew tnejn u ma jeħtiġux iktar trattament.
Injection of Dicural solution for injection under the skin may result in some itching, local swelling and slight pain.
L- injezzjoni ta ’ soluzzjoni ta ’ Dicural taħt il- ġilda tista ’ twassal għal xi ħakk, nefħa lokali u uġigħ ħafif.
The itching tends to disappear within a few minutes and the swelling within a few days.
Il- ħakk ġeneralment imur fi ftit minuti u n- nefħa fi żmien ftit jiem.
As for other fluoroquinolones, difloxacin should not be used in dogs that are growing quickly because it can affect the cartilage of some joints.
Bħall- fluoroquinolones l- oħra, difloxacin m’ għandux jintuża fi klieb li jkunu qed jikbru malajr minħabba li jista ’ jaffettwa l- qarquċa ta ’ xi ġogi.
This includes small- and medium-sized breeds up to and including eight months of age, large breeds up to one year of age and giant breeds up to 18 months of age.
Razez kbar sa sena fl- età u razez ġganteski sa 18- il xahar.
Dicural must not be used in epileptic dogs.
Dicural m’ għandux jintuża fi klieb epilettiċi.
In cattle, injection of Dicural solution for injection under the skin may result in some temporary swelling at the site of the injection.
Fl- ifrat, l- injezzjoni ta ’ soluzzjoni ta ’ Dicural għall- injezzjoni taħt il- ġilda tista ’ twassal għal nefħa temporanja fis- sit tal- injezzjoni.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
Liema prekawzjonijiet irid jieħu min jagħti l- mediċina jew jiġi f’ kuntatt mal- annimal?
People who are hypersensitive (allergic) to quinolones (a group of antibiotics that includes the fluoroquinolones) should avoid any contact with Dicural.
Persuni allerġiċi għal quinolones (grupp ta ’ antibijotiċi li jinkludu fluoroquinolones) għandhom jevitaw il- kuntatt ma ’ Dicural.
When handling Dicural oral solution for chickens and turkeys, use gloves and a face- protecting device to avoid irritation of the skin or eyes.
Meta tmiss is- soluzzjoni orali ta ’ Dicural għat- tiġieġ u d- dundjani, uża l- ingwanti u aċċesssorji għall- protezzjoni tal- wiċċ biex tevita li tirrita l- ġilda jew l- għajnejn.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Kemm irid jgħaddi ħin qabel ma l- annimal ikun jista ’ jinqatel u l- laħam tiegħu jntuża għall - konsum mill- bniedem (withdrawal period)?
Dicural must not be used in birds producing eggs for human consumption or within four weeks before the onset of the laying period.
Dicural m’ għandux jintuża fl- għasafar li jipproduċu l- bajd għall- konsum mill- bniedem jew fi żmien erba ’ xhur mill- bidu tal- perjodu tal- produzzjoni tal- bajd.
After the last administration of Dicural, chickens and turkeys should not be slaughtered for 24 hours and cattle should not be slaughtered for 46 days.
Wara l- aħħar amministrazzjoni ta ’ Dicural, it- tiġieġ u d- dundjani m’ għandhomx jinqatlu għal 24 siegħa u l- ifrat m’ għandhomx jinqatlu għal 46 jum.
Why has Dicural been approved?
Għaliex ġie approvat Dicural?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Dicural are greater than the risks for the treatment and recommended that Dicural be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Dicural huma ikbar mir- riskji tiegħu fit- trattament u rrakkomanda li Dicural jingħata l - 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 fil - modulu 6 ta ’ dan l- EPAR.
Other information about Dicural:
Tagħrif ieħor dwar Dicural:
The European Commission granted a marketing authorisation valid throughout the European Union, for Dicural to Fort Dodge Animal Health Holland on 16 January 1998.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Dicural valida madwar l- Unjoni Ewropea kollha, lil Fort Dodge Animal Health Holland fis- 16 ta ’ Jannar 1998.
The marketing authorisation was renewed on 16 January 2003 and on 16 January 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq iġġeddet fis- 16 ta ’ Jannar 2003 u fis- 16 ta ’ Jannar 2008.
Information on the prescription status of this product may be found on the label/ outer package.
Tagħrif dwar l- istejtus tal- preskrizzjoni jista ’ jinstab fuq it- tikketta/ pakkett ta ’ barra.
This summary was last updated in October 2008.
Dan is- sommarju ġie aġġornt l- aħħar fi: Ottubru 2008.
100 mg/ ml Oral solution
100 mg/ ml Soluzzjoni Orali
Chickens and turkeys
Flieles u dundjani
In drinking water
Fl- ilma tax- xorb
1 bottle
flixkun
Pack of 6 bottles
Pakkett ta ’ 6 fliexken
Dogs Dogs
Klieb
Blister (PVC/ Alu) Blister (PVC/ Alu)
Folja (PVC/ Alu)
10 tablets 20 tablets
10 pilloli Mhux Applikabbli
Not applicable Not applicable
20 pillola Mhux Applikabbli
15 mg 50 mg 50 mg 50 mg 100 mg 100 mg 100 mg 150 mg 150 mg 150 mg
100 pillola Mhux Applikabbli
Coated tablets Coated tablets Coated tablets Coated tablets Coated tablets Coated tablets Coated tablets Coated tablets Coated tablets Coated tablets
Folja (PVC/ Alu)
Dogs Dogs Dogs Dogs Dogs Dogs Dogs Dogs Dogs Dogs
10 pilloli Mhux Applikabbli
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
EU/ 2/ 97/ 003/ 008 Dicural
Blister (PVC/ Alu) Blister (PVC/ Alu) Blister (PVC/ Alu) Blister (PVC/ Alu) Blister (PVC/ Alu) Blister (PVC/ Alu) Blister (PVC/ Alu) Blister (PVC/ Alu) Blister (PVC/ Alu) Blister (PVC/ Alu)
Folja (PVC/ Alu)
100 tablets Not applicable 10 tablets Not applicable 20 tablets Not applicable 100 tablets Not applicable 10 tablets Not applicable 20 tablets Not applicable 100 tablets Not applicable 10 tablets Not applicable 20 tablets Not applicable 100 tablets Not applicable
20 pillola Mhux Applikabbli
EU/ 2/ 97/ 003/ 016 Dicural
EU/ 2/ 97/ 003/ 009 Dicural
Solution for injection
EU/ 2/ 97/ 003/ 013 Dicural
Cattle and dogs
Numru ta ’ l- UE
Subcutaneous use
Daqs tal - pakkett
Vial (glass)
Folja (PVC/ Alu)
50 ml
50 mg/ ml
1 vial Cattle:
Baqar:
46 days Dogs: not applicable
Mhux Applikabbli
Solution for injection
Soluzzjoni għall - Baqar injezzjoni
100 ml
Kunjett (ħġieġ) 100 ml
1 vial 46 days
46 ġurnata
250 ml
Kunjett (ħġieġ) 250 ml
SUMMARY OF PRODUCT CHARACTERISTICS 1.
KARATTERISTIĊI TAL- PRODOTT FIL- QOSOR 1.
Dicural 100 mg/ ml oral solution for chickens and turkeys
Dicural 100mg/ ml soluzzjoni orali għal flieles u d- dundjani
Each ml contains:
Kull ml fih:
Difloxacin (as hydrochloride)
Difloxacin (bħala hydrochloride)
Excipients:
Sustanzi mhux attivi
For a full list of excipients, see section 6.1
Għal- lista sħiħa ta ’ l- ingredjenti (mhux attivi), ara s- sezzjoni 6. 1
Oral solution
Soluzzjoni orali safranija, ċara.
Chickens (broilers and future breeders) Turkeys (young turkeys up to 2 kg body weight)
Flieles (tas- simna jew dawk miżmuma għar- razza) Dundjani (dundjani żgħar sa 2 kg piż korporali)
In chickens and turkeys:
Fi flieles u dundjani:
Dicural oral solution is indicated for treatment of chronic respiratory infections caused by sensitive strains of Escherichia coli and Mycoplasma gallisepticum.
Dicural soluzzjoni orali huwa indikat għal trattament ta ’ infezzjonijiet kroniċi respiratorji kkawżati minn razez sensittivi ta ’ Eschericia coli u Mycoplasma gallisepticum.
In turkeys:
Fid- dundjani:
Dicural oral solution is also indicated for the treatment of infections caused by Pasteurella multocida.
Dicural soluzzjoni orali huwa indikat ukoll għal trattament ta ’ infezzjonijiet ikkawżati minn Pasteurella multocida.
Since no studies were performed in clinically lame birds, Dicural should not be used in birds with existing leg-weakness or in birds suffering from osteoporosis.
Billi ma sarux studji fi tjur li kienu jzappu klinikament, Dicural m’ għandux jintuża fi tjur li għandhom saqajhom dgħajfa jew fi tjur li jbatu minn osteoporożi.
Special precautions for use in animals Heavy reliance on a single class of antibiotics may result in the induction of resistance in a bacterial population.
Prekawzjonijiet speċjali għall- użu fl- annimali Meta wieħed joqgħod fuq klassi waħda ta ’ antibijotiċi, jista ’ joħloq reżistenza f’ xi popolazzjoni ta ’ bakterja.
It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that have responded poorly, or are expected to respond poorly, to other classes of antibiotics.
Huwa prudenti li żżomm il- fluoroquinolones biss għal sitwazzjonijiet fejn antibijotiċi oħra ma ħadmux jew mhux mistenni li jkunu effettivi daqs kemm mixtieq.
Official and local antimicrobial policies should be taken into account when the product is used.
2/ 65 Il- politika lokali u uffiċjali kontra l- mikrobi għandha titieħed f’ konsiderazzjoni meta l- prodott jiġi wżat.
Whenever possible, fluoroquinolones should only be used based on susceptibility testing.
Meta possibli, fluoroquinolones għandhom jintużaw biss wara testijiet ta ’ suxxettibilità.
2/ 64 Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
L- użu tal- prodott b’ mod differenti mill- istruzzjonijiet mogħtija fl- SPC jista ’ jżid il- prevalenza ta ’ batterja reżistenti għall- fluoroquinolones u jista ’ jnaqqas l- effettività ta ’ kura b’ quinolones oħra minħabba l- potenzjal ta ’ cross resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals People with a known hypersensitivity to quinolones should avoid any contact with the product.
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali Nies li għandhom sensittività eċċessiva magħrufa għal quinolones għandhom jevitaw li jmissu mal - prodott.
In order to avoid irritation of skin and/ or eyes, use gloves and a face-protecting device when handling this product.
Sabiex tevita irritazzjoni lil ġilda u/ jew lil għajnejk, uża ingwanti u maskra sabiex tipproteġi wiċċek meta tuża dan il- prodott.
None known.
Xejn li hu magħruf
Do not use in birds in lay and/ or within 4 weeks before the onset of the laying period.
Tużax fi tjur fi żmien il- bajd, u/ jew fi żmien 4 ġimgħat sa meta jibdew ibidu.
4.8 Interaction with other veterinary medicinal products and other forms of interaction
4. 8 Effetti fuq prodotti mediċinali oħra jew effetti oħra
4.9 Amounts to be administered and administration route.
Il- medikazzjoni għandha titkompla għal ħamest ijiem.
Dicural oral solution must be administered daily in the drinking water in such a concentration that the dose is 10 mg/ kg bodyweight.
Meta tieħu kont tal- ammont ta ’ Difloxacin fis- soluzzjoni orali (10% w/ v), wieħed għandu jagħmel il - kalkulazzjoni li ġejja sabiex jiddetermina il- volum (ml) li għandu jżid ma kull elf litru ta ’ ilma:
The administration must be continued for 5 days.
Numru ta ’ annimali fil- maħżen
Taking into account the content of difloxacin in the oral solution (10%w/ v), the following calculation should be made to determine the volume (ml) to be added for each 1000 litres of water:
piż medju ta ’ kull annimal individwali (kg) X
number of animals in the house X mean weight of individual animal (kg) X 100 ----------------------------------------------------------------------------------------------------- total water consumption of the house on the previous day (litres)
100
The medicated drinking water should be prepared freshly each day.
Konsum totali ta ’ ilma fil- maħżen il- ġurnata ta ’ qabel (litri)
No other source of drinking water should be available during the medication period.
Waqt li qed tagħti l- ilma mmedikat, m’ għandu jkun hemm l- ebda sors ieħor ta ’ ilma.
At concentrations in the water of 0.03% (= 300 ml in 1000 litres) or greater, palatability for turkeys may be affected.
F’ konċentrazzjonijiet fl- ilma ta ’ 0. 03% (= 300ml f’ 1000 litru) jew aktar, it- togħma tista ’ taffetwa lid - dundjani.
4.10 Overdose (symptoms, emergency procedures, antidotes)
4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti) jekk ikun hemm bżonn
Target animal safety studies in chickens and turkeys demonstrated that, when administered in drinking water at 30 mg/ kg (chickens) or 22 mg/ kg (turkeys) for three times the recommended duration (15 consecutive days), difloxacin hydrochloride appeared to be safe for the birds.
Studji dwar il- ħarsien tas- saħħa fil- flieles u d- dundjani, urew li meta ġie amministrat fl- ilma tax- xorb f’ doża ta ’ 30mg / kg (flieles) jew 22mg/ kg (dundjani) għal tliet darbiet iż- żmien rakkomandat (għal 15 il- ġurnata wara xulxin), Difloxacin hydrochloride deher li ma kienx ta ’ ħsara għat- tjur.
4.11 Withdrawal periods
3/ 65 4. 11 Perjodu ta ’ Tiżmin
Meat and offal (chickens and turkeys):
Laħam u Interjur (flieles u dundjani):
Not authorised for use in laying birds producing eggs for human consumption.
Mhux permess li jintuża fi tjur tal- bajd li qed jipproduċu bajd għall- konsum tal- bniedem.
5.1 Pharmacodynamic properties
Kwalitajiet farmakodinamiċi
Pharmacotherapeutic group: general anti-infectives for systemic use; antibacterials for systemic use, quinolone antibacterials.
Grupp Farmako- terapewtiku: sustanza anti- infettiva ġenerali għal użu sistemiku, sustanza antibatterika għal użu sistemiku, antibatteriku tal- klassi Quinolone
ATC vet code:
Kodiċi ATĊ veterinarja:
The fluoroquinolones exert their antibacterial effect against both replicating and non-replicating micro-organisms.
Il- fluoroquinolones għandhom effett antibatteriku kemm kontra mikro- organizmi li jirreplikaw kif ukoll dawk li ma jirreplikawx.
Difloxacin hydrochloride is bactericidal in activity and acts by inhibition of bacterial DNA gyrase.
Il- hydrochloride ta ’ Difloxacin joqtol il- mikrobi billi jinibixxi l - attivita ta ’ DNA gyrase tal- bakterja.
Strains of Escherichia coli, Pasteurella multocida, Mycoplasma gallisepticum isolated from broilers and turkeys have been shown to be sensitive to difloxacin.
Ġie muri li razez ta ’ Eschericia coli, Pasteurella multocida, Mycoplasma gallisepticum, iżolati minn flieles tas- simna jew dundjani kienu kollha sensittivi għal Difloxacin.
Difloxacin is rapidly absorbed after oral administration to reach steady state plasma concentrations in a few hours after initiation of medication.
Difloxacin huwa assorbit malajr wara li jittieħed mill- ħalq u jilħaq stadju stabbli fil- plażma ftit siegħat wara l- bidu tal- medikazzjoni.
Difloxacin is well distributed throughout the animal body, as was demonstrated by the tissue to plasma ratios.
Difloxacin jitqassam sew fil- ġisem kollu kif kien muri bil- proporzjon li jinstab fit- tessuti u fil- plażma.
Difloxacin concentrations equal to or greater than the MICs for the relevant pathogens are achieved in all relevant tissues and maintained for as long as medication is continued.
Konċentrazzjonijiet ta ’ Difloxacin daqs jew akbar mill- MIC għal patoġeni relevanti, intlaħqu fit- tessuti relevanti kollha u baqgħu għolja matul iż- żmien ta ’ medikazzjoni.
Chickens:
Flieles:
96%).
Fit- tiġieġ, Difloxacin huwa assorbit kważi kollu wara li jiġi amministrat mill- ħalq (bejn wieħed u ieħor 96%).
It is well distributed in the body (Vd = 4.7 l/ kg) and has a plasma elimination half-life of approximately 7 hours.
Jitqassam tajjeb fil- ġisem (Vd = 4. 7 ltr/ kg) u għandu terminal half- life fil- plażma ta ’ madwar 7 siegħat.
Following continuous oral dosing with Dicural oral solution at 10 mg/ kg/ day for five consecutive days the mean difloxacin steady state plasma concentrations are approximately 200 ng/ ml.
Wara li Dicural soluzzjoni orali tingħata kontinwament mill- ħalq bir- rata ta ’ 10mg / kg/ ġurnata għal ħamest ijiem wara xulxin, il- medja tal- livell stabbli ta ’ Difloxacin bħala konċentrazzjonijiet fil - plażma kienu ta ’ madwar 200ng/ ml.
Tissue to plasma ratios range from 0.6 (abdominal fat), 2.4 (lung), 4.5 (muscle) to 14.1 (liver).
Il- proporzjon ta ’ tessut għal plażma kien ivarja minn 0. 6 (xaħam taż- żaqq), 2. 4 (pulmun), 4. 5 (muskoli) għal 14. 1 (fwied).
Turkeys:
Dundjani:
58%).
Fid- dundjani, il- biodisponibiltà ta ’ Difloxacin meta jingħata mill- ħalq hi moderata (madwar 58%).
It is very well distributed in the body (Vd = 9.9 l/ kg) and has a plasma elimination half-life of approximately 7 hours.
Difloxacin jitqassam tajjeb ħafna fil- ġisem (Vd = 9. 9 l/ kg) u għandu elimination half- life fil- plażma ta ’ madwar 7 siegħat.
Following continuous oral dosing of Dicural oral solution at 10 mg/ kg/ day for five consecutive days the mean difloxacin steady state plasma concentrations are approximately 60 ng/ ml.
Wara li Dicural soluzzjoni orali tingħata kontinwament mill- ħalq bir- rata ta ’ 10mg / kg/ ġurnata għal ħamest ijiem wara xulxin, il- medja tal- livell stabbli ta ’ Difloxacin bħala konċentrazzjonijiet fil- plażma kienu ta ’ madwar 60 ng/ ml.
Tissue to plasma ratios range from 2.5 (abdominal fat), 3.7 (muscle), 4.8 (lung) to 36.5 (liver).
Il- proporzjon ta ’ tessut għal plażma kien ivarja minn 2. 5 (xaħam taż- żaqq), 3. 7 (muskoli), 4. 8 (pulmun) għal 36. 5 (fwied).
In both species difloxacin may be conjugated (glucuronidated or sulphated), desmethylated into sarafloxacin or oxidised into N-oxide-difloxacin.
Fiż- żewġ speċi, Difloxacin jista ’ jkun ikkonjugat (glukuronat jew sulfatizzat), desmetilizzat f’ sarafloxaċin jew ossidat f ’ N- ossidu ta ’ Difloxacin.
The main metabolites are hydrolysable conjugates of difloxacin, the other metabolites are proportionally minor ones.
Il- metaboliti ewlenin huma konjugati idrolisabbli ta’ Difloxacin, il- metaboliti l- oħra huma proporzjonalment ftit.
Edetic acid Potassium hydroxide Propylene glycol Benzyl alcohol Purified water
Edetic acid
4/ 64 6.2 Incompatibilities
4/ 65 Potassium hydroxide Propylene glycol Benzyl alcohol Ilma ppurifikat
No additional chlorine, for example from the use of water chlorinators, or hydrogen peroxide should be added to the drinking water used with this product..
M’ għandhux jiżdied klorin, per eżempju mill- użu ta ’ apparat ta ’ klorinazzjoni, jew hydrogen peroxide, mal- ilma tax- xorb użat ma ’ dan il- prodott.
6.3 Shelf-life
6. 3 Żmien ta 'kemm il- prodott idum tajjeb
Shelf life of the veterinary medicinal product as packaged for sale:
Żmien li l- prodott mediċinali veterinarju jibqa ’ tajjeb kif ippakkjat għall- bejgħ:
Medicated water must be freshly prepared daily.
3 snin Ilma mmedikat għandu jiġi ppreparat frisk kuljum.
1 month.
Perjodu ta ’ ħażna wara li jinfetaħ il- kontenitur: xahar
Protect from light.
Taħżinx f' temperaturi ogħla minn 25°Ċ.
White HDPE bottles with a screw cap containing 250 ml or 1 litre of Dicural oral solution.
Fliexken tal- HDPE bojod, b’ tapp bil- kamin li fihom 250ml jew litru ta ’ Dicural soluzzjoni orali.
The screw cap on the 1 litre bottle can be used as a measuring device.
It- tapp bil- kamin fil- flixkun tal- litru jista ’ jintuża biex tkejjel bih.
If filled to the brim the measuring device provides 50 ml.
Jekk timlieh sax- xfar, tkun imlejt 50ml.
For the 250 ml bottle a separate measuring device is placed on the screw cap.
Għal flixkun tal- 250ml, hemm kejl separat fuq it- tapp tal- kamin.
Measuring lines indicate the volume supplied.
Is- sinjali tal- kejl juru il- volum li tkun imlejt.
Not all pack sizes may be marketed.
Mhux id- daqsijiet kollha tal- pakketti jistgħu jitpoġġew fis- suq
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if any
6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użata jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp The Netherlands
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp l- Olanda.
DATE OF RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI / TIĠDID TAL- AWTORIZZAZZJONI
10.
5/ 65 10.
15.01.2008
{MM/ 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 /.
5/ 64 PROHIBITION OF SALE, SUPPLY AND/ OR USE
PROJBIZZJONI TA ’ BEJGĦ, PROVVISTA U / JEW UŻU
Dicural 15 mg coated tablets for dogs Dicural 50 mg coated tablets for dogs Dicural 100 mg coated tablets for dogs Dicural 150 mg coated tablets for dogs
Dicural 15 mg pilloli miksija għal klieb Dicural 50 mg pilloli miksija għal klieb Dicural 100 mg pilloli miksija għal klieb Dicural 150 mg pilloli miksija għal klieb
Active substance:
Sustanzi Attiv/ i:
Dicural 15 mg Dicural 50 mg
difloxacin (bħala hydrochloride) Dicural 15 mg
difloxacin (as hydrochloride) difloxacin (as hydrochloride)
difloxacin (bħala hydrochloride)
15 mg 50 mg
Dicural 50 mg
Dicural 100 mg Dicural 150 mg
Dicural 100 mg
100 mg 150 mg
Dicural 150 mg
For a full list of excipients, see
150mg
section 6.1
Għal- lista sħiħa ta ’ l- ingredjenti (mhux attivi), ara s- sezzjoni 6. 1
Coated tablets
Pilloli miksija, kannella fl- isfar, ibbuzzati fuq iż- żewġ naħat.
For the treatment of: • Acute uncomplicated urinary tract infections caused by Escherichia coli or Staphylococcus spp. • Superficial pyoderma caused by Staphylococcus intermedius.
Għall- kura ta ’: • Infezzjonijiet akuti u bla kumplikazzjonijiet fis- sistema tal- urina, ikkawżati minn speċi suxxettibbli ta ’ Eschericia coli jew Staphylococcus spp. • Infezzjoni superfiċjali (pijoderma) ikkawżata minn Staphylococcus intermedius.
As for other quinolones, due to possible adverse effects on the articular cartilage of weight bearing joints difloxacin should not be used during the rapid growth phase, that is, do not use in small and medium-sized breeds of dogs up to and including 8 months of age, in large breeds up to 1 year of age and in giant breeds up to 18 months of age.
Fi kliem ieħor tużax fi klieb ta ’ razza żgħira jew meżżana li għandhom jew se jagħlqu t- tmien xhur, razez kbar sa sena u f’ razez ta ’ klieb ġganti sa 18 il- xahar.
Do not use in epileptic dogs.
Tużax fi klieb li jtihom aċċessjonijiet
4.4 Special warnings
M’ hemm xejn magħruf
None known.
4. 5 Prekawzjonijiet Speċjali għall- Użu
7/ 64 4.5 Special precautions for use
7/ 65 Meta wieħed joqgħod fuq klassi waħda ta ’ antibijotiċi, jista ’ joħloq reżistenza f’ xi popolazzjoni ta ’ bakterja.
Special precautions for use in animals Heavy reliance on a single class of antibiotics may result in the induction of resistance in a bacterial population.
Il- politika lokali u uffiċjali kontra l- mikrobi għandha titieħed f’ konsiderazzjoni meta l- prodott jiġi wżat.
It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that have responded poorly, or are expected to respond poorly, to other classes of antibiotic.
Meta possibli, fluoroquinolones għandhom jintużaw biss wara testijiet ta ’ suxxettibilità.
Special precautions to be taken by the person administering the veterinary medicinal product to animals.
L- użu tal- prodott b’ mod differenti mill- istruzzjonijiet mogħtija fl- SPC jista ’ jżid il- prevalenza ta ’ batterja reżistenti għall- fluoroquinolones u jista ’ jnaqqas l- effettività ta ’ kura b’ quinolones oħra minħabba l- potenzjal ta ’ cross resistance.
People with a known hypersensitivity to quinolones should avoid any contact with the product.
Nies għandhom sensittività eċċessiva magħrufa għal quinolones għandhom jevitaw li jmissu mal - prodott.
Adverse reactions were rare in dogs treated with difloxacin.
Effetti mhux mixtieqa kienu rari fil- klieb ikkurati b’ Difloxacin.
The observed reactions were inappetence, emesis, diarrhoea and anal irritation.
Ir- reazzjonijiet osservati kienu nuqqas ta ’ aptit, rimettar, dijarea, u irritazzjoni fil- warrani.
These adverse reactions were self-limiting within one or two days and did not require additional treatment.
Dawn l- effetti mhux mixtieqa kienu temporanji u damu minn ġurnata sa tnejn mingħajr il- ħtieġa ta ’ aktar kura.
The reproductive safety of the veterinary medicinal product has only been evaluated in laboratory animals, the use of difloxacin in pregnant or lactating bitches or male stud dogs is therefore not recommended.
Is- sigurtà riproduttiva tal- prodott mediċinali veterinarju ġie evalwat biss f’ annimali fil- laboratorju, għalhekk l- użu ta ’ Difloxacin fi klieb tqal jew ireddgħu, jew klieb irġiel miżmuma għar- razza mhux rakkomandat
The use of fluoroquinolones in combination with non-steroidal anti-inflammatory drugs (NSAIDs) may cause seizures.
L- użu ta ’ fluoroquinolones flimkien ma ’ mediċini ant- infjammatorji li mhumiex sterojdi (NSAIDS) jista ’ jikkawża aċċessjonijiet
Antacids may interfere with gastro-intestinal absorption.
Sustanzi antiaċidi jistgħu jinterferixxu milli s- sustanza tiġi assorbita mill- istonku.
Nitrofurantoin may impair quinolone efficacy if used concurrently in the treatment of urinary tract infections.
Nitrofurantoin jista ’ jnaqqas l- effikaċja ta ’ quinolones jekk jintużaw flimkien waqt infezzjonijiet tal - passaġġ tal- urina
The recommended dose of difloxacin is 5 mg/ kg bodyweight per day.
Id- doża rakkomandata ta ’ difloxacin hija ta ’ 5mg/ kg piż tal- ġisem kuljum.
Dicural coated tablets should be given once a day for at least 5 days.
Dicural, pilloli miksija, għandu jingħata darba kuljum għal mill- anqas ħamest ijiem.
Superficial pyoderma may require treatment for up to a maximum of 21 days.
Pijoderma superfiċjali jista jkollha bżonn trattament sa massimu ta ’ 21 ġurnata.
The tablets should be administered for at least 2 days beyond the cessation of clinical signs.
Il- pilloli għandhom jiġu amministrati tal- anqas għal jumejn wara li jmorru s- sintomi.
Therapy should be re-evaluated if no improvement is seen within 5 days, or 10 days in the case of superficial pyoderma.
4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti) jekk ikun hemm bżonn
Dogs treated orally with difloxacin (as hydrochloride) at 10 times the recommended dose for 10 days occasionally showed mild adverse reactions such as orange/ yellowing discoloration of the faeces, emesis and hypersalivation.
Klieb li huma kkurati b ’ Difloxacin (bħala hydrochloride) mill- ħalq, għal 10 darbiet id- doża rakkomandata għal 10 t’ ijiem, okkażjonalment urew reazzjonijiet ħfief ta ’ tibdil fil- kulur tal- ħmieġ, rimettar u tbeżlieq żejjed.
Histopathological changes were noted in the articular cartilage of weight bearing joints of young (3.5 months old) beagle dogs after the oral administration of difloxacin at doses of greater than 5 mg/ kg/ day for 90 days.
Tibdil ħistopatoloġiku kien innutat fil- qarquċa artikulari tal- ġogi li jġorru l- piż fi klieb tal- beagle żgħar (tliet xhur u nofs) wara amministrazzjoni orali ta ’ Difloxacin f’ dożi aktar minn 5 mg / kg / kuljum (bħala hydrochloride) għal disgħin jum.
No specific antidotes for difloxacin (or other quinolones) are known, therefore, in case of overdose symptomatic treatment should be given.
8/ 65 M’ hemm l- ebda antidot għal Difloxacin (jew quinolones oħra), għaldaqstant, f’ każ ta ’ doża eċċessiva, għandu jingħata trattament simptomatiku.
8/ 64 4.11 Withdrawal period
4. 11 Perjodu ta ’ Tiżmin
PHARMACOLOGICAL PROPERTIES
5, KWALITAJIET FARMAKOLOĠIĊI
QJ01MA94
Kodiċi ATĊ veterinarja:
Difloxacin is an aryl-fluoroquinolone with a broad spectrum of antimicrobial activity.
QJ01MA94 Difloxacin huwa aryl- fluroquinolone bi spettru wiesgħa ta ’ attività antibatterika.
Difloxacin can be bactericidal against many Gram-negative micro-organisms and a selection of Gram-positive micro- organisms.
Difloxacin jista ’ joqtol ħafna mikro- organiżmi Gram- negative u għażla silettiva ta ’ organiżmi Gram- pożittivi
The fluoroquinolones exert their antibacterial effects against both replicating and dormant micro- organisms.
Il- fluoroquinolones għandhom effett antibatteriku kemm kontra mikro- organizmi li jirreplikaw kif ukoll dawk li m’ humiex attivi.
Difloxacin acts primarily through inhibition of bacterial DNA gyrase.
Difloxacin joqtol il- mikrobi primarjament billi jinibixxi l- attivita ta ’ DNA gyrase tal- bakterja.
The following organisms were tested and found to be susceptible to difloxacin in vitro:
Dawn l- organiżmi kienu suxxettibbli għal Difloxacin in vitro:
Escherichia coli Klebsiella spp.
Eschericia coli Klebsiella spp.
The following organisms were found to be of intermediate susceptibility:
Dawn l- organiżmi nstabu li kellhom suxxettibilita intermedja:
Following an oral dose (a plain tablet) in dogs of 5 mg/ kg bodyweight, difloxacin reached its average peak plasma concentration of 1.8 µg/ ml in approximately 3 hours.
Wara doża mill- ħalq, (pillola) ta ’ 5mg/ kg piż fi klieb, Difloxacin laħaq il- medja tal- ogħla livelli fil - plażma ta ’ 1. 8 mikrogrammi / ml f’ madwar tlett siegħat.
Approximately 95% of the oral dose was absorbed.
Bejn wieħed u ieħor 95% tad- doża li ngħatat mill- ħalq kienet assorbita.
The elimination half-life averaged 9.3 hours.
Il- medja tal- half- life tal- eliminazzjoni kienet 9. 3 siegħat.
Long term daily oral treatment over 180 days at 5 mg/ kg bodyweight did not influence difloxacin kinetics, neither by accumulation nor by increased drug metabolism.
Trattament mill- ħalq fit- tul, għal aktar minn 180 ġurnata b’ doża ta ’ 5mg / kg piż ma nfluwenzax il - movimenti ta ’ Difloxacin la bħala akkumulazzjoni u lanqas bħala żieda fir- rata ta ’ metaboliżmu.
Sodium starch glycollate Microcrystalline cellulose Magnesium stearate Colloidal silicon dioxide Sodium lauryl sulphate Lactose Sodium croscarmellose
Sodium starch glycollate Microcrystalline cellulose Magnesium stearate Colloidal silicon dioxide
9/ 64 Micronised brewer’ s yeast Aromatic liver flavour
9/ 65 Sodium lauryl sulphate Lactose Sodium croscarmellose Micronised brewer’ s yeast Aromatic liver flavour
6.4 Special precautions for storage
Sentejn
Do not store above 25 °C.
Taħżinx f' temperaturi ogħla minn 25°Ċ.
6.5 Nature and contents of container
6. 5 In- natura u l- għamla ta ’ l- ewwel ippakkjar
PVC/ aluminium blisters with 10 tablets per blister.
Strixxa magħmula mill- PVC/ aluminjum li fiha 10 pilloli.
Cardboard boxes of 1, 2 or 10 blisters.
Kaxxi tal- kartun li fihom 1, 2 jew 10 strixxi.
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp The Netherlands
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp l- Olanda
15.01.2008
MM/ 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 /
PROHIBITION OF SALE, SUPPLY AND/ OR USE
PROJBIZZJONI TA ’ BEJGĦ, PROVVISTA U / JEW UŻU
10/ 64 1.
10/ 65 1.
Dicural 50 mg/ ml solution for injection for cattle and dogs
Dicural 50mg/ ml soluzzjoni għal injezzjoni għal baqar u klieb.
Active substance:
Sustanzi Attiva:
Solution for injection
Soluzzjoni għall- injezzjoni safranija, ċara.
Cattle (calves and young cattle) Dogs
Baqar (għoġġiela u erieħ) Klieb.
In cattle:
Fil- baqar:
Dicural 50 mg/ ml solution for injection is indicated for the treatment of bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida, and/ or Mycoplasma spp.
Dicural 50 mg/ ml soluzzjoni għal injezzjoni hija indikata għal trattament tal- marda respiratorja bovina (deni ta ’ waqt it- tbaħħir, pnewmonja fl- għoġġiela) ikkawżata minn mikrobu wieħed jew ħafna tipi bħal Pasteurella haemolitica, Pateurella multocida, u / jew Mycoplasma intermedius.
In dogs:
Fil- klieb:
Dicural 50 mg/ ml solution for injection is indicated for the treatment of: • Acute uncomplicated urinary tract infections caused by Escherichia coli or Staphylococcus spp • Superficial pyoderma caused by Staphylococcus intermedius.
Dicural 50 mg/ ml soluzzjoni għal injezzjoni hija indikata għal trattament ta ’: • Infezzjonijiet akuti u bla kumplikazzjonijiet fis- sistema tal- urina, ikkawżati minn speċi suxxettibbli ta ’ Eschericia coli jew Staphylococcus spp. • Infezzjoni pijoderma superfiċjali kkawżata minn Staphylococcus intermedius.
4.3 Contraindications
4. 2 Kontra indikazzjonijiet
Cattle:
Baqar:
As for other quinolones, due to possible adverse effects on the articular cartilage of weight bearing joints, difloxacin should not be used during the rapid growth phase.
Klieb Bħal fil- każ ta ’ quinolones oħra, minħabba l- possibilita ta ’ effetti mhux mixtieqa fuq il- qarquċa artikulari ta ’ ġogi li jerfgħu il- piż, Difloxacin m’ għandux jintuża waqt il- fażi ta ’ tkabbir mgħaġġel.
Therefore, do not use in small and medium-sized breeds of dogs up to and including 8 months of age, in large breeds up to 1 year of age and in giant breeds up to 18 months of age.
Għalhekk, tużax fi klieb ta ’ razza żgħira jew meżżana li għandhom jew sa tmien xhur, razez kbar sa sena u f’ razez ta ’ klieb ġganti sa 18 il- xahar.
4.4 Special warnings for each target species
11/ 65 4. 4 Twissijiet speċjali għal kull speċi li għaliha hu indikat il- prodott
None known.
Xejn
11/ 64 4.5 Special precautions for use
4. 5 Prekawzjonijiet Speċjali għall- Użu
Whenever possible, fluoroquinolones should only be used based on susceptibility testing.
Il- politika lokali u uffiċjali kontra l- mikrobi għandha titieħed f’ konsiderazzjoni meta l- prodott jiġi wżat.
Official and local antimicrobial policies should be taken into account when the product is used.
Meta possibli, fluoroquinolones għandhom jintużaw biss wara testijiet ta ’ suxxettibilità.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
L- użu tal- prodott b’ mod differenti mill- istruzzjonijiet mogħtija fl- SPC jista ’ jżid il- prevalenza ta ’ batterja reżistenti għall- fluoroquinolones u jista ’ jnaqqas l- effettività ta ’ kura b’ quinolones oħra minħabba l- potenzjal ta ’ cross resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals People with a known hypersensitivity to quinolones should avoid any contact with the product.
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali Nies li għandhom sensittività eċċessiva magħrufa għal quinolones għandhom jevitaw li jmissu mal - prodott mediċinali veterinarju.
In target animal safety studies, subcutaneous administration was generally well tolerated.
Fi studji fuq annimali li l- prodott hu indikat għalihom, amministrazzjoni taħt il- ġilda kien ġeneralment ittollerat tajjeb.
Transient swelling at the injection site following administration may occur.
Tista ’ tfiġġ nefħa temporanja fis- sit tal- injezzjoni
Pruritis and/ or local swellings and occasionally a slight pain reaction on injection have been observed.
Tnixxija u / jew nefħiet, u okkażjonalment reazzjonijiet ta ’ ftit uġigħ waqt l- injezzjoni kienu osservati.
In general the pruritis disappears within a few minutes and the local swelling within a few days.
Ġeneralment it- tnixxija titlaq fi ftit minuti u n- nefħa lokali wara ftit ġranet.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Il- ħarsien tas- sahha tal- prodott mediċinali veterinarju ma ġiex stabbilit waqt it- tqala u fi żmien il- ħalib.
The use of fluoroquinolones in combination with non-steroidal anti-inflammatory drugs (NSAIDs) may cause seizures.
L- użu ta ’ fluoroquinolones jista ’ joħloq aċċessjonijiet jek jingħata ma NSAIDS.
Antagonism may be observed with nitrofurantoin.
Jista ’ jkun hemm antagoniżmu ma nitrofurantoin.
Subcutaneous use.
Użu għal taħt il- ġilda
The recommended dose is 2.5 mg difloxacin/ kg bodyweight/ day for 3 days (i. e.
Id- doża rakkomandata hija 2. 5 mg Difloxacin/ kg piż tal- ġisem kuljum għal tliet ijiem (ie.
If there is insufficient improvement after 3 days, the treatment can be continued for another 2 days.
5 ml/ kg piż tal- ġisem) Jekk m’ hemmx progress suffiċjenti wara tliet ijiem, it- trattament jista ’ jitkompla għal jumejn oħra.
For complicated respiratory disease the dose can be doubled to 5 mg/ kg bodyweight/ day.
12/ 65 Għal mard respiratorju kkumplikat id- doża tista ’ tiġi rdoppjata għal 5 mg/ kg piż tal- ġisem kuljum.
The volume administered per injection site in cattle should not exceed 7 ml.
Il- volum injettat f’ kull lok ta ’ injezzjoni fil- baqar m’ għandux ikun aktar minn 7 ml.
A new injection site should be used each day.
Għandu jintuża lok għall- injezzjoni ġdid kuljum.
12/ 64 Dogs:
Klieb:
The recommended dose is a single injection of 5.0 mg difloxacin/ kg bodyweight.
Id- doża rakkomandata hija injezzjoni waħda ta ’ 5. 0 mg Difloxacin / kg piż tal- ġisem.
Treatment must then be continued with Dicural Coated Tablets (see that SPC).
It- trattamnet għandu jitkompla b’ Difloxacin pilloli miksija (ara l- SPC).
The volume administered per injection site in dogs should not exceed 5 ml.
Il- volum injettat f’ kull lok ta ’ injezzjoni fil- klieb m’ għandux ikun aktar minn 5 ml.
At very high doses adverse effects on the nervous system (ataxia, unsteadiness, twitching, tremors, convulsions, etc) may occur in cattle.
F’ dożi għolja ħafna, effetti mhux mixtieqa fuq is- sistema nervuża (sturdament, tbandil, tregħid, taqlib, etc.) jistgħu jiġru fil- baqar.
Overdosage may also give rise to oedema and swelling in the knee joints.
Doża eċċessiva tista ’ toħloq edima u nefħa fl- irkupptejn.
The oral administration of difloxacin at up to 5 times the recommended dose rate for 30 days did not result in any adverse reactions.
L- amministrazzjoni mill- ħalq ta ’ Difloxacin sa 5 darbiet id- doza rakkomandata għal 30 gurnata ma rrizultat fl- ebda effetti mhux mixtieqa.
In another study, dogs treated orally with difloxacin at 10 times the recommended dose for 10 days showed occasionally mild adverse reactions such as orange/ yellowing discoloration of the faeces, emesis and hypersalivation.
Fi studju ieħor, klieb ittrattati mill- ħalq b’ Difloxacin b’ 10 darbiet id- doza rakkomandata għal 10 ijiem okkazjonalment urew effetti mhux mixtieqa moderati bħal kulur oranġjo/ isfar fil- ħmieġ, rimettar u ipersalivazzjoni.
No specific antidotes for difloxacin (or other quinolones) are known, therefore in case of overdosage symptomatic treatment should be given.
Mhumiex magħrufa antidoti speċifiċi għal Difloxacin (jew quinolones oħra), għalhekk f’ każ ta ’ doża eċċessiva, għandu jingħata trattament simptomatiku.
4.11 Withdrawal period
4. 11 Perjodu ta ’ Tiżmin
Meat and offal:
Laħam u Interjur:
46 days
46 ġurnata
PHARMACOLOGICAL PROPERTIES
5 KWALITAJIET FARMAKOLOĠIĊI
The fluoroquinolones exert their antibacterial effect against both replicating and dormant micro- organisms.
Il- fluoroquinolones għandhom effett antibatteriku kemm kontra mikro- organizmi li jirreplikaw kif ukoll dawk li m’ humiex attivi.
Difloxacin hydrochloride can be bactericidal in activity and acts primarily through inhibition of bacterial DNA gyrase.
Difloxacin joqtol il- mikrobi primarjament billi jinibixxi l- attivita ta ’ DNA gyrase tal- bakterja.
Escherichia coli Staphylococcus intermedius
Mycoplasma spp Eschericia coli Staphylococcus intermedius
The following organism was found to be of intermediate susceptibility:
Dawn l- organiżmi nstabu li kellhom suxxettibilita intermedja:
13/ 64 Induction of resistance against quinolones can develop by mutations in the gyrase gene of bacteria and by changes in cell permeability towards quinolones
13/ 65 Staphylococcus spp.
After subcutaneous administration of difloxacin peak plasma levels of 1.7 µg/ ml are achieved at 6 hours post dosing.
Wara amministrazzjoni taħt il- ġilda, Difloxacin laħaq il- medja tal- ogħla livelli fil- plażma ta ’ 1. 7 mikrogrammi / ml sitt siegħat wara.
After subcutaneous administration the bioavailability is 88% and the volume of distribution is 2.5 l/ kg.
Wara titqiba taħt il- ġilda, il- biodisponibiltà hija ta ’ 88% u l- volum ta ’ distribuzzjoni hu ta ’ 2. 5 l/ kg.
The parent compound difloxacin is the major component in the faeces and tissues.
Difloxacin hu l- akbar komponent fil- ħmieġ u t- tessut.
In the urine, liver, fat and kidneys the metabolites desmethyl-difloxacin and difloxacin N-oxide can be found in small amounts in addition to the major (parent) compound.
Fl- urina, fwied, xaħam u kliewi, il- metaboliti desmetil Difloxacin u N – ossidu ta ’ Difloxacin jinstabu fi kwantitajiet żgħar flimkien mal- komponent ewlieni (Difloxacin).
The clearance of difloxacin after subcutaneous administration to cattle is 229 ml/ h/ kg.
It- tneħħija ta ’ Difloxacin wara amministrazzjoni taħt il- ġilda għal baqar kienet ta ’ 229 ml/ h/ kg.
A half-life time of 7.7 hours has been observed.
Il - half- life fil- plażma kien ta ’ 7. 7 siegħat.
68 - 82%) is excreted via the faeces.
Il- parti l- kbira ta ’ Difloxacin (68 – 82%) kien imneħħi fil - ħmieġ.
7 - 18%) is eliminated via the urine.
Parti minn Difloxacin (7 – 18%) kien imneħħi mill- urina.
After subcutaneous administration of difloxacin peak plasma levels of 1.4 -1.9 µg/ ml are achieved in 3.1 hours post dosing.
Wara amministrazzjoni taħt il- ġilda, Difloxacin laħaq l- ogħla livelli fil- plażma ta ’ 1. 4 – 1. 9 mikrogrammi / ml fi 3. 1 siegħat wara l- amministrazzjoni.
The volume of distribution is 2.6 l/ kg.
Wara titqiba taħt il- ġilda, il - biodisponibiltà hija ta ’ 96% u l- volum ta ’ distribuzzjoni hu ta ’ 2. 6 l/ kg.
A half-life time of 5.8 hours has been observed.
Kien osservat half- life ta ’ 5. 8 siegħat.
The majority of difloxacin is excreted via the faeces.
Il- parti l- kbira ta ’ Difloxacin kien imneħħi fil- ħmieġ.
A fraction of difloxacin is eliminated by the urine.
Parti oħra kienet imneħħija mill- urina.
6.1 List of excipients
6. 1 Inkompatibilitajiet Maġġuri
Ethanol Benzyl alcohol Propylene glycol Arginine Water for injections
Ethanol Benzyl alcohol Propylene glycol Arginine Ilma għall- injezzjonijiet
Shelf life after first use of the product:
Perjodu ta ’ ħażna wara li jinfetah il- kontenitur:
Keep the container in the outer carton.
Taħżinx f' temperaturi ogħla minn 25 °Ċ Tiffriżax Żomm il- kontenitur fil- pakkett ta ’ barra
Cardboard box with one glass vial of 50 ml with a rubber stopper and aluminium cap.
Kaxxa tal- kartun bi fjala tal- ħġieġ ta ’ 50 ml b’ tapp tal- lastku u għatu ta ’ l- aluminjum
14/ 64 Cattle:
14/ 65 Baqar:
Cardboard box with one glass vial of 50 ml, 100 ml or 250 ml with a rubber stopper and aluminium cap.
Kaxxa tal- kartun bi fjala tal- ħġieġ ta ’ 50 ml, 100 ml jew 250 ml b’ tapp tal- lastku u għatu ta ’ l - aluminjum
Not all pack sizes may be marketed.
Mhux id- daqs sijiet kollha tal- pakketti jistgħu jitpoġġew fis- suq
15/ 64 ANNEX II
15/ 65 ANNESS II
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
SID TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY AND USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L- AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL- PROVISTA JEW L- UŻU
16/ 64 A.
16/ 65 A.
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
Name and address of the manufacturers responsible for batch release:
Isem u indirizz tal- manufattur( i) tas- sustanza( i) bioloġika( ċi) attiva( i)
For all three pharmaceutical forms:
Għat- tliet għamliet farmaċewtiċi:
Camprodón, s/ n “ La Riba” E-17813 Vall de Bianya (Girona) Spain
Camprodón, s/ n “ La Riba ” E- 17813 Vall de Bianya (Girona) Spanja
Manufacturing Authorisation issued on 4 March 1997 by Ministerio de Agricultura, Spain.
L- Awtorizzazzjoni tal- Manifattura inħarġet fl- 4 ta ’ Marzu 1997 mill- Ministerio de Agricultura, Spanja.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY AND USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR IL- PROVISTA U L- UŻU