qanastek/EMEA-V3 huggingface dataset:
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Id- detentur ta ’ din l- awtorizzazzjoni tal- kummerċ għandu jinforma lil Kummissjoni Ewropea dwar il - pjanijiet tal- kummerċ għal prodott mediċinali b’ din id- deċiżjoni.
which are accepted in accordance with Council Regulation (EEC) No 2377/ 90 and in accordance with Article 31 (3b) of Council Regulation (EEC) No 2309/ 93 of 22 July 1993, as amended.
li huma aċċettati b’ mod konformi mar- Regolament tal- Kunsill (KEE) Nru 2377/ 90 u b’ mod konformi ma ’ l- Artikolu 31 (3b) tar- Regolament tal- Kunsill (KEE) Nru 2309/ 93 tat- 22 ta ’ Lulju 1993, kif emendati.
17/ 64 Annex I of Council Regulation (EEC) No 2377/ 90
17/ 65 Anness I tar- Regolament tal- Kunsill (KEE) Nru 2377/ 90
Pharmacologically
Sustanza
Marker
Residwu li
Animal
Speċje
residue
ta ’ l -
Species
mmirati
tissues
oħrajn
provisions
annimal Tjur1
Not for use in
M’ għandux
Skin + fat Liver Kidney
Ġilda + xaħam Fwied Kliewi
animals from which eggs are produced for human consumption
jintuża f’ annimali li minnhom jittieħdu l- bajd għal konsum mill- bniedem
Muscle Fat Liver Kidney
Muskolu Xaħam Fwied Kliewi
Not for use in animals from which milk is produced for human consumption
M’ għandux jintuża f’ annimali li minnhom jittieħed il- ħalib għal produzzjoni għal konsum mill- bniedem
Annex II of Council Regulation (EEC) No 2377/ 90
Anness II tar- Regolament tal- Kunsill (KEE) Nru 2377/ 90
Oral solution:
Soluzzjoni orali:
Pharmacologically active substance
Sustanzi farmakoloġikament attivai
Animal Species
Speċje ta ’ l- annimal
Other provisions
Dispożizzjonijiet oħrajn
All food-producing species
L- ispeċji kollha li jipproduċu l- ikel
Benzyl alcohol6 Hydrochloric acid7
Benzyl alcohol6
For use as excipient For use as excipient
Biex jintuża bħala sustanza mhux attiva
Solution for injection:
Hydrochloric acid7
Pharmacologically active substance
Biex jintuża bħala sustanza mhix attiva
Other provisions
Soluzzjoni għall- injezzjoni:
Ethanol 8 Propylene glycol 9 Benzyl alcohol 10 Arginine 11
Sustanza( i) farmakoloġikament attiva( i) Ethanol 8 Propylene glycol 9 Benzyl alcohol 10 Arginine 11
All food-producing species
Speċje ta ’ l- annimal L- ispeċji kollha li jipproduċu l- ikel
For use as excipient
Dispożizzjonijiet oħrajn Biex jintuża bħala sustanza mhux attiva
1 OJ No.
1 OJ Nru.
L 172 of 02.07.02 2 OJ No.
L 172 ta ’ 02. 07. 02 2 OJ Nru.
L 172 of 02.07.02 3 OJ No.
L 172 ta ’ 02. 07. 02 3 OJ Nru.
L 290 of 5.12.95 4 OJ No.
L 290 ta ’ 5. 12. 95 4 OJ Nru.
L 272 of 25.10.96 5 OJ No.
L 272 ta ’ 25. 10. 96 5 OJ Nru.
L 45 of 15.02.97 6 OJ No.
L 45 ta ’ 15. 02. 97 6 OJ Nru.
L 143 of 27.06.95 7 OJ No.
L 143 ta ’ 27. 06. 95 7 OJ Nru.
L 143 of 27.06.95 8 OJ No.
L 143 ta ’ 27. 06. 95 8 OJ Nru.
L 143 of 26.06.95 9 OJ No.
L 143 ta ’ 26. 06. 95 9 OJ Nru.
L 45 of 15.02.97 10 OJ No L 143 of 26.06.95 11 OJ No.
L 45 ta ’ 15. 02. 97 10 OJ Nru L 143 ta ’ 26. 06. 95 11 OJ Nru.
L 240 of 10.09.99
L 240 ta ’ 10. 09. 99
18/ 64 ANNEX III
18/ 65 ANNESS III
19/ 64 A.
19/ 65 A.
20/ 64 PARTICULARS TO APPEAR ON THE OUTER PACKAGE PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Dicural oral solution CARTON LABEL - 1 X 250 ML BOTTLE / 1 X 1000 ML BOTTLE / 6 X 1000 ML BOTTLE VIAL LABEL 250 ml bottle / 1000 ml bottle
20/ 65 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI Dicural soluzzjoni orali TIKKETTA TAL- KARTUNA – FLIXKUN 1 x 250 ML / FLIXKUN 1 X 1000 ML / 6 FLIEXKEN X 1000 ML TIKKETTA TAL- FJALA Flixkun ta ’ 250 ml / flixkun ta ’ 1000 ml
Difloxacin (as hydrochloride)
Difloxacin (bħala hydrochloride) Benzyl alcohol
TARGET SPECIES
SPEĊI GĦAL XIEX HUWA INDIKAT IL- PRODOTT
Chickens (broilers and future breeders) and turkeys (young turkeys up to 2 kg body weight).
Flieles (tas- simna jew miżmuma għar- razza) u dundjani (dundjani żgħar li jiżnu sa 2 kg piż korporali).
INDICATIONS
INDIKAZZJONI( JIET)
Chickens and turkeys - for treatment of chronic respiratory infections caused by sensitive strains of Escherichia coli and Mycoplasma gallisepticum.
Fi flieles u dundjani, għal trattament ta ’ infezzjonijiet kroniċi respiratorji kkawżati minn strejns sensittivi ta ’ Eschericia coli u Mycoplasma gallisepticum.
Turkeys only - for the treatment of infections caused by Pasteurella multocida.
Fid- dundjani biss - għal trattament ta ’ nfezzjonijiet ikkawżati minn Pasteurella multocida.
For oral administration in drinking water.
Għall- amministrazzjoni mill- ħalq fl- ilma tax- xorb.
Withdrawal periods - Meat and offal (chickens and turkeys):
Żmien ta ’ Tiżmim - Laħam u nterjur (sriedaq u dundjani):
21/ 64 Not authorised for use in laying birds producing eggs for human consumption.
21/ 65 Mhux permess biex jintuża fi tjur li qed ibidu u jipproduċu l- bajd għal konsum uman.
SPECIAL WARNINGS
TWISSIJIET SPEĊJALI OĦRA, JEKK MEĦTIEĠ
People with a known hypersensitivity to quinolones should avoid any contact with the product.
Nies li għandhom sensittività eċċessiva għal quinolones għandhom jevitaw li jmissu mal- prodott.
EXP {month/ year} Medicated water must be freshly prepared daily.
Jiskadi {xahar/ sena} Ilma medikat għandu jkun ippreparat frisk kuljum.
1 month.
Jekk tiftaħ uża fi żmien xahar.
Do not store above 25 °C.
Taħżinx f' temperatura ’ l fuq minn 25°Ċ.
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, JEKK IKUN IL- KAŻ
[Not requested on the immediate label]
[Mhux meħtieġa fuq it- tikketta li tmiss mal- prodott]
Dispose of waste material in accordance with local requirements.
Mediċina veterinarja li ma ġietx użata jew prodotti oħra li ntużaw għal din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
IL- KLIEM "GĦAL TRATTAMENT TA ’ L- ANNIMALI BISS ” U KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVISTA U L- UŻU, jekk applikabbli
For animal treatment only - to be supplied only on veterinary prescription.
Għal trattament ta ’ l- annimali biss - għandu jingħata biss bi preskrizzjoni medika.
Marketing authorisation holder:
Sid l- Awtorizzazzjoni għal Kummerċ:
MARKETING AUTHORISATION NUMBER(S)
NUMRU TA ’ L- AWTORIZAZZJONI TAL- KUMMERĊ
EU/ 2/ 97/ 003/ 001 – 1 x 250 ml EU/ 2/ 97/ 003/ 002 – 1 x 1000 ml EU/ 2/ 97/ 003/ 003 – 6 x 1000 ml
22/ 65 EU/ 2/ 97/ 003/ 001 – 1 x 250 ml EU/ 2/ 97/ 003/ 002 – 1 x 1000 ml EU/ 2/ 97/ 003/ 003 – 6 x 1000 ml
23/ 64 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Dicural 15 mg Coated tablets CARTON OF 10 TABLETS / 20 TABLETS / 100 TABLETS
KARTUNA TA ’ 10 PILLOLI / 20 PILLOLA / 100 PILLOLA
Dicural 15 mg coated tablets for dogs
Dicural 15 mg pilloli miksija għal klieb
10 tablets 20 tablets 100 tablets
10 pilloli 20 pillola 100 pillola
Oral use.
Jingħata mill- ħalq.
[Not applicable.]
[Mhux applikabbli.]
24/ 64 10.
24/ 65 10.
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 NL- 1381 CP Weesp The Netherlands
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp l- Olanda.
EU/ 2/ 97/ 003/ 004 – 10 tablets EU/ 2/ 97/ 003/ 005 – 20 tablets EU/ 2/ 97/ 003/ 006 – 100 tablets
EU/ 2/ 97/ 003/ 004 – 10 pilloli EU/ 2/ 97/ 003/ 005 – 20 pillola EU/ 2/ 97/ 003/ 006 – 100 pillola
25/ 64 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Dicural 50 mg Coated tablets CARTON OF 10 TABLETS / 20 TABLETS / 100 TABLETS
25/ 65 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA Dicural 50 mg Pilloli miksija KARTUNA TA ’ 10 PILLOLI / 20 PILLOLA / 100 PILLOLA
Dicural 50 mg Coated tablets for dogs
Dicural 50 mg pilloli miksija għal klieb
Difloxacin (as the hydrochloride) 50 mg
Difloxacin (bħala hydrochloride) 50 mg
Read the package leaflet before use.
Jittieħed mill- ħalq.
[Space shall be provided for the prescribed dose to be indicated on the outer carton]
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett
[Not applicable.]
Mhux applikabbli.
26/ 64 10.
26/ 65 10.
Do not store above 25°C.
Taħżinx f' temperatura ’ l fuq minn 25°Ċ.
To be supplied only on veterinary prescription.
Għal trattament ta ’ l- annimali biss - għandu jingħata biss bi preskrizzjoni medika.
Marketing authorisation holder Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 NL- 1381 CP Weesp The Netherlands
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp l- Olanda.
MARKETING AUTHORISATION NUMBER(S)
NUMRI TA ’ L- AWTORIZAZZJONI GĦALL- KUMMERĊ
EU/ 2/ 97/ 003/ 007 – 10 tablets EU/ 2/ 97/ 003/ 008 – 20 tablets EU/ 2/ 97/ 003/ 009 – 100 tablets
EU/ 2/ 97/ 003/ 007 – 10 pilloli EU/ 2/ 97/ 003/ 008 – 20 pillola EU/ 2/ 97/ 003/ 009 – 100 pillola
27/ 64 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Dicural 100 mg Coated tablets CARTON OF 10 TABLETS / 20 TABLETS / 100 TABLETS
27/ 65 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA Dicural 100 mg Pilloli miksija KARTUNA TA ’ 10 PILLOLI / 20 PILLOLA / 100 PILLOLA
Dicural 100 mg Coated tablets for dogs
Dicural 100 mg pilloli miksija għal klieb
Difloxacin (as the hydrochloride) 100 mg
Difloxacin (bħala hydrochloride) 100 mg
28/ 64 10.
28/ 65 10.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA ’ MEDIĊINA MHUX UŻATA JEW MATERJAL IEĦOR, JEKK IKUN IL- KAŻ
To be supplied only on veterinary prescription.
Għal trattament ta ’ l- annimali biss - għandu jingħata biss bi preskrizzjoni medika
MARKETING AUTHORISATION NUMBER(S)
NUMRU TA ’ L- AWTORIZAZZJONI GĦALL- KUMMERĊ
EU/ 2/ 97/ 003/ 010 – 10 tablets EU/ 2/ 97/ 003/ 011 – 20 tablets EU/ 2/ 97/ 003/ 012 – 100 tablets
EU/ 2/ 97/ 003/ 010 – 10 pilloli EU/ 2/ 97/ 003/ 011 – 20 pillola EU/ 2/ 97/ 003/ 012 – 100 pillola
29/ 64 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Dicural 150 mg Coated tablets CARTON OF 10 TABLETS / 20 TABLETS / 100 TABLETS
29/ 65 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA Dicural 150 mg Pilloli miksija KARTUNA TA ’ 10 PILLOLI / 20 PILLOLA / 100 PILLOLA
Dicural 150 mg Coated tablets for dogs
Dicural 150 mg pilloli miksija għal klieb
30/ 64 10.
30/ 65 10.
EU/ 2/ 97/ 003/ 013 – 10 tablets EU/ 2/ 97/ 003/ 014 – 20 tablets EU/ 2/ 97/ 003/ 015 – 100 tablets
EU/ 2/ 97/ 003/ 013 – 10 pilloli EU/ 2/ 97/ 003/ 014 – 20 pillola EU/ 2/ 97/ 003/ 015 – 100 pillola
31/ 64 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Dicural 15 mg coated tablets Blister label
31/ 65 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS Dicural 15 mg pilloli miksija Tikketta tal- blister
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM IS- SID TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
Fort Dodge Animal Health Holland
Fort Dodge Animal Health – l- Olanda
32/ 64 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Dicural 50 mg Coated tablets Blister label
32/ 65 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS Dicural 50 mg pilloli miksija Tikketta tal- blister
33/ 64 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Dicural 100 mg Coated tablets Blister label
33/ 65 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS Dicural 100 mg pilloli miksija Tikketta tal- blister
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM IS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ
34/ 64 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Dicural 150 mg Coated tablets Blister label
34/ 65 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS Dicural 150 mg pilloli miksija Tikketta tal- blister
35/ 64 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Dicural 50 mg/ ml, solution for injection for cattle and dogs CARTON for 50 ml vial
35/ 65 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA Dicural 50 mg/ ml soluzzjoni għal injezzjoni għal baqar u klieb KARTUNA għal fjala ta ’ 50ml
Dicural 50 mg/ ml, solution for injection for cattle and dogs
Dicural 50 mg/ ml soluzzjoni għal injezzjoni għal baqar u klieb
Difloxacin (as the hydrochloride) Benzyl alcohol
Difloxacin (bħala hydrochloride) Benzyl alcohol
Cattle (calves and young cattle), and dogs
Baqar (għoġġiela u erieħ) u klieb
Cattle: • Treatment of Bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida, and/ or Mycoplasma spp.
Baqar: • Trattament tal- marda respiratorja bovina (deni ta ’ waqt it- tbaħħir, pnewmonja fl- għoġġiela) ikkawżati minn mikrobu wieħed jew ħafna tipi bħal Pasteurella haemolitica, Pateurella multocida, u/ jew Mycoplasma spp.
Treatment of: • Acute uncomplicated urinary tract infections caused by Escherichia coli or Staphylococcus spp • Superficial pyoderma caused by Staphylococcus intermedius.
Trattament ta ’: • Infezzjonijiet akuti u bla kumplikazzjonijiet fis- sistema tal- urina, ikkawżati minn Eschericia coli jew Staphylococcus spp. • Infezzjoni pijoderma superfiċjali kkawżata minn Staphylococcus intermedius
8.
36/ 65 8.
Withdrawal period:
Żmien ta ’ Tiżmim:
Cattle - meat and offal 46 days
46 ġurnata.
28 days
Jiskadi {xahar/ sena} Jekk tiftaħ uża fi żmien 28 ġurnata.
Keep the container in the outer carton.
Żomm il- kontenitur fil- kaxxa ta ’ barra tiegħu.
Marketing authorisation holder Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 NL-1381 CP Weesp The Netherlands
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp l- Olanda.
17.
37/ 65 17.
37/ 64 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Dicural 50 mg/ ml, solution for injection for cattle and dogs 50 ml vial label
38/ 65 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR Dicural 50 mg/ ml soluzzjoni għal injezzjoni għal baqar u klieb Tikketta għal fjala ta ’ 50 ml
Dicural 50 mg/ ml, solution for injection for cattle and dogs
Dicural 50 mg/ ml soluzzjoni għal injezzjoni għal baqar u klieb.
ACTIVE SUBSTANCES
KWANTITÀ TAS- SUSTANZA ATTIVA / SUSTANZI ATTIVI
50 mg/ ml
50 mg / ml
METHOD AND ROUTE(S) OF ADMINISTRATION
MOD TA ’ AMMINISTRAZZJONI
Subcutaneous use
Użu taħt il- ġilda.
Withdrawal period:
Żmien ta ’ Tiżmin:
Cattle - meat and offal 46 days
Baqar – laħam u interjur 46 ġurnata.
28 days
Jiskadi {xahar/ sena} Jekk tiftaħ uża fi żmien 28 ġurnata
[MA Number recommended, but not required on the immediate label] EU/ 2/ 97/ 003/ 016
[In- Numru ta ’ l- Awtorizzazzjoni tal- Kummerċ mhux meħtieġ fuq it- tikketta li tmiss mal- prodott] EU/ 2/ 97/ 003/ 016
38/ 64 PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE PACKAGE Dicural 50 mg/ ml solution for injection for cattle OUTER CARTON for 100 ml vial / 250 ml vial / VIAL LABEL 100 ml vial / 250 ml vial
KARTUNA TA ’ BARRA għal fjala ta ’ 100 ml / fjala ta ’ 250 ml / TIKKETTA TAL- FJALA ta ’ fjala ta ’ 100 ml / fjala ta ’ 250 ml
Dicural 50 mg/ ml solution for injection for cattle
Dicural 50 mg/ ml soluzzjoni għall- injezzjoni għal baqar.
Cattle (calves and young cattle)
Baqar (għoġġiela u erieħ)
Treatment of Bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida, and/ or Mycoplasma spp.
Trattament tal- marda respiratorja bovina (deni ta ’ waqt it- tbaħħir, pnewmonja fl- għoġġiela) ikkawzati minn mikrobu wieħed jew ħafna tipi bħal Pasteurella haemolitica, Pateurella multocida, u / jew Mycoplasma spp.
Subcutaneous use.
Jingħata taħt il- ġilda.
[Space shall be provided for the prescribed dose to be indicated on the outer carton]
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett [Spazju għandu jiġi provdut sabiex id- doża preskritta tiġi indikata fuq il- kartuna ta ’ barra]
Meat and offal 46 days
Laħam u nterjur, 46 ġurnata
39/ 64 9.
40/ 65 9.
Do not store above 25°C.
Taħżinx f' temperatura l- fuq minn 25°Ċ.
[Not required on the immediate label]
[Mhix meħtieġa fit- tikketta li tmiss mal- prodott]
To be supplied only on veterinary prescription..
Għal trattament ta ’ l- annimali biss.
[Not required on the immediate label] Keep out of the reach and sight of children.
[Mhix meħtieġa fit- tikketta li tmiss mal- prodott] Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 NL-1381 CP Weesp The Netherlands
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp l- Olanda.
EU/ 2/ 97/ 003/ 017 – 100 ml EU/ 2/ 97/ 003/ 018 – 250 ml
[Rakkomandat, imma mhux meħtieġ fit- tikketta li tmiss mal- prodott] EU/ 2/ 97/ 003/ 017 – 100 ml EU/ 2/ 97/ 003/ 018 – 250 ml
Lot {number}
41/ 65 Lott {numru}
42/ 64 PACKAGE LEAFLET FOR:
43/ 65 FULJETT TA ’ TAGĦRIF FIL- PAKKETT GĦAL:
Dicural 100 mg/ ml oral solution for chickens and turkeys
Dicural 100 mg/ ml soluzzjoni orali għal flieles u dundjani
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ, U L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L- KONSENJA TMUR FIS- SUQ, JEKK DIFFERENTI ISEM TAL- PRODOTT MEDIĊINALI VETERINARJU
Marketing authorisation holder Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 NL-1381 CP Weesp The Netherlands
Sid l- Awtorizzazzjoni tal- Kummerċ Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 NL- 1381 CP Weesp l- Olanda
Manufacturer for the batch release Fort Dodge Veterinaria S. A.
Manifattur li jħalli l- konsenja tmur fis- suq Fort Dodge Veterinaria S. A.
Dicural 100 mg/ ml oral solution for chickens and turkeys
Dicural 100 mg/ ml soluzzjoni orali għal flieles u d- dundjani
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S)
DIKJARAZZJONI TAS- SUSTANZA ATTIVA U SUSTANZI OĦRA
Active substance Difloxacin (as hydrochloride)
Difloxacin (bħala hydrochloride)
INDICATIONS
4 INDIKAZZJONI( JIET)
Dicural oral solution is indicated for treatment of chronic respiratory infections caused by sensitive strains of Escherichia coli and Mycoplasma gallisepticum.
Fi flieles u dundjani, Dicural soluzzjoni orali huwa indikat għal trattament ta ’ infezzjonijiet kroniċi respiratorji kkawżati minn strejns sensittivi ta ’ Eschericia coli u Mycoplasma gallisepticum.
Dicural oral solution is also indicated for the treatment of infections caused by Pasteurella multocida.
Fid- dundjani Dicural soluzzjoni orali huwa indikat ukoll għal trattament ta ’ nfezzjonijiet ikkawżati minn Pasteurella multocida.
Since no studies were performed in clinically lame birds, Dicural oral solution 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
43/ 64 6.
44/ 65 6.
Chickens (broilers and future breeders) Turkeys (young turkeys up to 2 kg body weight)
Flieles (tas- simna jew miżmuma għar- razza) Dundjani (dundjani żgħar sa 2 kg piż tal- ġisem).
DOSAGE FOR EACH SPECIES, METHOD AND ROUTE OF ADMINISTRATION
DOŻA GĦAL KULL SPEĊJE, MOD( I) U METODU TA 'AMMINISTRAZZJONI
For oral administration in drinking water.
X
For the 250 ml bottle a separate measuring device is placed on the screw cap.
Għal flixkun tal- 250 ml, kejl separat qiegħed fuq it- tapp tal- kamin.
Measuring lines indicate the volume supplied.
Is- sinjali tal- kejl juru il - volum li tkun imlejt.
The medicated drinking water should be prepared freshly each day.
L- ilma tax- xorb immedikat għandu jkun ippreparat frisk kuljum.
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.
WITHDRAWAL PERIODS
PERJODU TA ’ TIŻMIM
Meat and offal (chicken 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
44/ 64 Do not freeze.
45/ 65 Taħżinx f' temperaturi ogħla minn 25°Ċ.
Shelf-life after first opening the container:
Ipproteġi mid- dawl.
1 month.
Tiffriżax.
Do not use after the expiry date which is stated on the label after EXP.
Iż- żmien kemm idum tajjeb il- prodott wara li jinfetaħ: xahar Tużax wara d- data tal- iskadenza fuq it- tikketta wara Jiskadi
Heavy reliance on a single class of antibiotics may result in the induction of resistance in a bacterial population.
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 antibiotic.
Huwa prudenti li żżomm il - fluoroquinolones biss għal sitwazzjonijiet fejn antibijotiċi oħra ma ħadmux jew mhux mistenni li jkunu effettivi daqs kemm mixtieq.
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.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR RIMI TA 'PRODOTT MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED
DATA META ĠIE APPROVAT L- AĦĦAR IL- FULJETT INFORMATTIV FIL- PAKKETT
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /.
OTHER INFORMATION
TAGĦRIF IEHOR
Dicural oral solution is a yellowish clear aqueous solution and is supplied in plastic white bottles with a screw cap containing 250 or 1000 ml oral solution.
Dicural soluzzjoni orali hija soluzzjoni trasparenti safranija u hija ppreżentata fi fliexken bojod tal - plastik b’ tapp tal- kamin li jkun fihom 250 jew 1000 ml tas- soluzzjoni orali.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Għal kull tagħrif dwar dan il- prodott mediċinali veterinarju, jekk jogħġbok ikkuntattja lir - rappreżentant lokali tas- sid tal- Awtorizzazzjoni tal- Kummerċ.
47/ 64 PACKAGE LEAFLET FOR:
48/ 65 FULJETT TA ’ TAGĦRIF FIL- PAKKETT GĦAL:
Dicural coated tablets for dogs
Dicural Pilloli miksija għal klieb
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 NL-1381 CP Weesp The Netherlands
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 NL- 1381 CP Weesp l- Olanda
Carretera Camprodón, s/ n - La Riba E-17813-Vall de Bianya (Girona) Spain
Camprodón, s/ n “ La Riba ” E- 17813 Vall de Bianya (Girona) Spanja
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
DIKJARAZZJONI TAS- SUSTANZA ATTIVA U SUSTANZI OĦRA
difloxacin (as hydrochloride) difloxacin (as hydrochloride)
difloxacin (bħala hydrochloride) difloxacin (bħala hydrochloride) difloxacin (bħala hydrochloride) difloxacin (bħala hydrochloride)
Dicural coated tablets are indicated for the following clinical conditions in dogs: • Acute uncomplicated urinary tract infections caused by Escherichia coli or Staphylococcus spp. • Superficial pyoderma caused by Staphylococcus intermedius.
Dicural pilloli miksija huma ndikati għal dawn il- kundizzjonijiet kliniċi fil- klieb: • Infezzjonijiet akuti u bla kumplikazzjonijiet fis- sistema ta ’ l- urina, ikkawżati minn speċi suxxettibbli ta ’ Eschericia coli jew Staphylococcus spp. • Infezzjoni superfiċjali (pijoderma) ikkawżata minn Staphylococcus intermedius.
Dicural Coated Tablets should only be used based on susceptibility testing.
Dicural Pilloli Miksija għandhom jintużaw biss wara testijiet ta ’ suxxettibilita
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 breed 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 sa u jew jinkludi t- tmien xhur, razez kbar sa sena u f’ razez ta ’ klieb ġganti sa 18 il- xahar.
Do not use in epileptic dogs.
49/ 65 Tużax fi klieb li jtihom aċċessjonijiet
The observed reactions were inappetence, emesis, diarrhoea, and anal irritation.
Ir- reazzjonijiet osservati kienu inappettenza, rimettar, dijarea, u irritazzjoni fil- warrani.
DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION
DOŻA GĦAL KULL SPEĊJE, MOD( I) U METODU TA 'AMMINISTRAZZJONI
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.
Therapy should be re-evaluated if no improvement is seen within 5 days, or 10 days in the case of superficial pyoderma.
It- trattament għandu jerġa jiġi kkunsidrat jekk l- ebda progress ma jsir fi żmien 5 t’ ijiem jew 10 t’ ijiem fil- każ ta ’ pijoderma superficjali.
Small
Żgħir
Bodyweight (kg) 0-3
Piż tal- ġisem (kg) 0– 3
For oral use.
Għal użu mill- ħalq
SPECIAL STORAGE PRECAUTIONS
TAGĦRIF SPEĊJALI GĦALL- ĦAŻNA
Do not use after the expiry date which is stated on the carton after EXP.
Tużax wara d- data tal- iskadenza fuq il- kartuna wara JIS.
12.
50/ 65 12.
49/ 64 The use of difloxacin in pregnant or lactating bitches or male stud dogs is not recommended.
L- użu ta ’ Difloxacin fi klieb li huma tqal jew qed ireddgħu jew fi klieb maskili miżmuma għar- razza mhux rakkomandat.
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.
Huwa prudenti li żżomm il- fluoroquinolones biss għal sitwazzjonijiet fejn antibijotiċi oħra ma ħadmux jew mhux mistenni li jkunu effettivi daqs kemm mixtieq.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
TAGĦRIF DWAR RIMI TA ’ MEDIĊINA MHUX UŻATA JEW MATERJAL ĦAŻIN IEHOR, JEKK IKUN IL- KAŻ
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /
For animal treatment only - to be supplied only on veterinary prescription.
Għal trattament tal- annimali biss - għandu jingħata biss bi preskrizzjoni medika
Dicural Coated Tablets consist of a core tablet containing difloxacin hydrochloride and a highly palatable coating.
Dicural pilloli miksija jikkonsistu minn pillola li fiha difloxacin hydrochloride u kisi li għandu togħma tajba ħafna.
Each strength of the product is available in packs of 10, 20 and 100 tablets.
Kull qawwa tal- prodott tiġi f’ pakketti ta ’ 10, 20 u 100 pillola.
Not all pack sizes may be marketed.
Mhux id- daqs tal- pakketti kollha jistgħu qegħdin fis- suq
Difloxacin is an aryl-fluoroquinolone with a broad spectrum of antimicrobial activity.
Difloxacin huwa aryl- fluoroquinolone bi spettru wiesa ta ’ attività antibatterika.
Difloxacin can be bactericidal against many Gram-negative micro-organisms and a selection of Gram-positive micro- organisms.
Difloxacin joqtol ħafna mikro- organiżmi Gram negative u uħud Gram positive.
Pasteurella spp.
51/ 65 Pasteurella spp.
50/ 64 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.
For any information about this veterinary medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali veterinarju, jekk jogħġbok ikkuntattja lir - rappreżentant lokali tas- sid tal- Awtorizzazzjoni tal- Kummerċ.
53/ 64 PACKAGE LEAFLET FOR:
54/ 65 FULJETT TA ’ TAGĦRIF FIL- PAKKETT GĦAL:
Dicural 50 mg/ ml solution for injection for cattle and dogs
Dicural 50 mg/ ml, soluzzjoni għall- injezzjoni għal baqar u klieb
Fort Dodge Veterinaria S. A.
Manifattur li jħalli l- konsenja tmur fis- suq Fort Dodge Veterinaria S. A.
Dicural 50 mg/ ml solution for injection for cattle and dogs
Dicural 50 mg/ ml, soluzzjoni għall- injezzjoni għal baqar u klieb.
Treatment of Bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida, and/ or Mycoplasma spp.
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.
Dogs: treatment of: • Acute uncomplicated urinary tract infections caused by Escherichia coli or Staphylococcus spp • Superficial pyoderma caused by Staphylococcus intermedius.
Klieb: trattament 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.
CONTRAINDICATIONS
5 KONTRA INDIKAZZJONIJIET
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
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 ugiegh waqt l- injezzjoni kienu osservati.
Cattle (calves and young cattle) Dogs
Baqar (għoġġiela u erieħ)\ Klieb
DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION
8 DOŻA GĦAL KULL SPEĊJE, MOD( I) U METODU TA 'AMMINISTRAZZJONI
The recommended dose is 2.5 mg difloxacin/ kg bodyweight per day for 3 days (that is, 5ml/ 100 kg bodyweight) by subcutaneous administration.
Id- doża rakkomandata hija 2. 5mg Difloxacin / kg piż tal- ġisem/ jum għal tlett ijiem (ie.
If there is insufficient improvement after 3 days, the treatment can be continued for another 2 days.
5ml / kg piż tal - ġisem/ jum) Jekk m’ hemmx progress suffiċjenti wara tlett ijiem, it- trattament jista ’ jitkompla għal jumejn oħra.
For complicated respiratory disease the dose can be doubled to 5 mg/ kg bodyweight per day.
Għal mard respiratorju kkumplikat id- doża tista ’ tirdoppja għal 5 mg/ kg piż tal - ġisem/ jum.
The recommended dose is a single subcutaneous injection of 5.0 mg difloxacin/ kg body weight.
Id- doża rakkomandata hija ta ’ 5 mg Difloxacin / kg piż tal- ġisem bħala injezzjoni waħda.
Treatment must then be continued with Dicural Coated Tablets (read the Package Leaflet for that product).
It- trattamnet għandu jitkompla b’ Dicural pilloli miksija (aqra l- fuljett ta ’ tagħrif ta ’ dan il- prodott)
In cattle, the volume administered per injection site should not exceed 7 ml.
Il- volum injettat f’ kull lok ta ’ injezzjoni fil- baqar m’ għandux ikun aktar minn 7 ml.
In dogs, the volume administered per injection site should not exceed 5 ml.
Il- volum mogħti f’ kull lok ta ’ injezzjoni fil- klieb m’ għandux ikun aktar minn 5 ml.
In the absence of incompatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Fin- nuqqas ta ’ studji dwar kompattibilita, dan il- prodott mediċinali veterinarju ma jistax jintuża flimkien ma prodotti mediċinali veterinarji oħra.
Meat and offal 46 days
Laħam u interjur 46 ġurnata
Shelf-life after first use of the product:
Żomm il- kontenitur fil- pakkett ta ’ barra Perjodu ta ’ ħażna wara li jinfetah il- kontenitur:
Do not use after the expiry date stated on the vial.
28 ġurnata Tużax wara d- data ta ’ skadenza ta ’ fuq il- flixkun.
Dicural 50 mg/ ml solution for injection should only be used based on susceptibility testing.
Meta possibli, fluoroquinolones għandhom jintużaw biss wara testijiet ta ’ suxxettibilità.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
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.
The use of fluoroquinolones in combination with non-steroidal anti-inflammatory drugs (NSAIDs) may cause seizures.
Il- sigurtà tal- prodott mediċinali veterinarju ma ġiex stabbilit waqt it- tqala u fi żmien il- ħalib L- użu ta ’ fluoroquinolones jista ’ joħloq aċċessjonijiet jekk jingħata ma ’ NSAIDS.
Antagonism may be observed with nitrofurantoin.
Jista ’ jkun hemm antagoniżmu ma ’ nitrofurantoin.
Overdose
Doża eċċessiva:
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.
Doza eċċessiva tista ’ toħloq edima u nefħa fl- irkupptejn.
In dogs the oral administration of difloxacin at up to 5 times the recommended dose rate for 30 days did not result in any adverse reactions.
Fil- klieb 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 tbeżlieq żejjed.
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.
15.01.2008
[ħalli vojt – id- data tad- Deċiżjoni tal- Kummissjoni għat- Tiġdid għandu jiġi inserit hawn u implimentat mid- Detentur ta ’ L- Awtorizzazzjoni tal- Kummerċ]
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /
For animal treatment only.
Għal trattament tal- annimali biss.
To be supplied only on veterinary prescription.
Għandu jingħata biss bi preskrizzjoni medika
Dicural 50 mg/ ml, solution for injection for cattle and dogs is available in the following presentations:
Dicural 50mg/ ml soluzzjoni għal injezzjoni għal baqar u klieb jinstab f’ dawn il- preżentazzjonijiet:
50, 100 and 250 ml vials.
flixkun ta ’ 50 ml flixkun ta ’ 50, 100 u 250 ml
For any information about this veterinary medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali veterinarju, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tas- Sid tal- Awtorizzazzjoni tal- Kummerċ:
59/ 64 PACKAGE LEAFLET Dicural 50 mg/ ml, solution for injection for cattle
Dicural 50 mg/ ml, soluzzjoni għall- injezzjoni fil- baqar
Carretera Camprodón, s/ n - La Riba 17813-Vall de Bianya (Girona) Spain
Campro’ don, s/ n “ La Riba ” 17813 Vall de Bianya (Girona) Spanja.
Dicural 50 mg/ ml, solution for injection for cattle
Dicural 50 mg/ ml soluzzjoni għall- injezzjoni għal baqar soluzzjoni għal injezzjoni għal baqar
Active substance Difloxacin (as the hydrochloride)
Difloxacin (bħala hydrochloride)
50 mg/ ml
50 mg/ 1ml
Treatment of Bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida, and/ or Mycoplasma spp.
Trattament tal- marda respiratorja bovina (deni ta ’ waqt it- tbaħħir, pnewmonja fl- għoġġiela) ikkawzata minn mikrobu wieħed jew ħafna tipi bħal Pasteurella haemolitica, Pateurella multocida, u/ jew Mycoplasma spp.
In target animal safety studies, subcutaneous administration in cattle was generally well tolerated.
Fi studji fuq annimali li l- prodott hu indikat għalihom, amministrazzjoni taħt il- ġilda kien ġeneralment ittollerat tajjeb.
The dose by subcutaneous administration for cattle is 2.5 mg difloxacin/ kg bodyweight per day for 3 days (that is, 5ml/ 100 kg bodyweight).
5 ml/ 100 kg piż tal- ġisem/ jum).
If there is no sufficient improvement after 3 days, the treatment can be continued for another 2 days.
Jekk m’ hemmx progress suffiċjenti wara tlett ijiem, it- trattament jista ’ jitkompla għal jumejn oħra.
For complicated respiratory disease the dose can be doubled to 5 mg/ kg per day.
Għal mard respiratorju kkumplikat id- doża tista ’ tirdoppja għal 5 mg/ kg piż tal - ġisem/ jum.
In cattle, the volume administered per injection site should not exceed 7 ml; consecutive daily doses have to be administered at different injection sites.
Għandu jintuża lok għall- injezzjoni ġdid kuljum.
Meat and offal 46 days
46 ġurnata
Do not store above 25°C.
Taħżinx f' temperaturi ogħla minn 25°Ċ.
Do not use after the expiry date stated on the vial.
28 ġurnata Tużax wara d- data ta ’ skadenza ta ’ fuq il- fjala wara Jiskadi
Dicural 50 mg/ ml solution for injection 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.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Meta possibli, fluoroquinolones għandhom jintużaw biss wara testijiet ta ’ suxxettibilità.
The use of fluoroquinolones in combination with non-steroidal anti-inflammatory drugs (NSAIDs) may cause seizures.
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.
Antagonism may be observed with nitrofurantoin.
Il- sigurtà tal- prodott mediċinali veterinarju ma ġiex stabbilit waqt it- tqala u fi żmien il- ħalib
People with a known hypersensitivity to quinolones should avoid any contact with the product.
L- użu ta ’ fluoroquinolones jista ’ joħloq aċċessjonijiet jekk jingħata ma ’ NSAIDS.
61/ 64 Overdose At very high doses adverse effects on the nervous system (ataxia, unsteadiness, twitching, tremors, convulsions, etc.) may occur in cattle; in this target species overdosing may also give rise to oedema and swelling in the knee joints.
62/ 65 Jista ’ jkun hemm antagoniżmu ma ’ nitrofurantoin.
No specific antidote for difloxacin (or other quinolones) is known.
Nies li għandhom sensittività eċċessiva għal quinolones għandhom jevitaw li jmissu mal- prodott.
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.
OTHER INFORMATION
TAGĦRIF IEĦOR.
Dicural 50 mg/ ml, solution for injection for cattle is available in 50, 100 and 250 ml vials.
Dicural 50 mg/ ml soluzzjoni għall- injezzjoni għal baqar jiġi fi fjali ta ’ 50, 100 u 250 ml.
For any information about this veterinary medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali veterinarju, jekk jogħġbok ikkuntattja lir - rappreżentant lokali tas- Sid tal- Awtorizzazzjoni tal- Kummerċ:
This document is a summary of the European Public Assessment Report.
Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropea (EPAR).
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
Lgħan tiegħu huwa li jispjega kif il- valutazzjoni mwettqa mill- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) fuq il- bażi tad- dokumentazzjoni pprovduta, wasslet għarrakkomandazzjonijiet fuq il- kundizzjonijiet ta ’ l- użu.
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 ilkondizzjoni medika jew dwar it- trattament ta ’ l- annimal tiegħek, jekk jogħġbok ikkuntattja lillveterinarju tiegħek.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is DRAXXIN?
X’ inhu DRAXXIN?
DRAXXIN contains tulathromycin, which belongs to a class of medicines having an antibiotic action.
DRAXXIN fih tulathromycin, li jappartieni għall- klassi ta ’ mediċini li għandhom azzjoni antibijotika.
DRAXXIN is a solution for injection (100 mg/ ml).
DRAXXIN huwa soluzzjoni għal injezzjoni (100 mg/ ml).
What is DRAXXIN used for?
Għalxiex jintuża DRAXXIN?
DRAXXIN is used to treat the following diseases if they are caused by bacteria that are sensitive to tulathromycin: • bovine respiratory disease (BRD) in cattle caused by Mannheimia haemolytica, Pasteurella multocida, Histophilus somni or Mycoplasma bovis, • infectious bovine keratoconjunctivitis (IBK) in cattle, an eye disease caused by Moraxella bovis, • swine respiratory disease (SRD) in pigs caused by Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae or Haemophilus parasuis.
DRAXXIN jintuża biex jittratta l- mard li ġej jekk huwa kkawżat minn batterji li huma sensittivi għal tulathromycin: • mard respiratorju bovin (BRD) fi frat ikkawżat minn Mannheimia haemolytica, Pasteurella multocida, Histophilus somni jew Mycoplasma bovis, • keratokonġunktivite bovina infettuża (IBK) fi frat, mard ta ’ l- għajnejn ikkawżata minn Moraxella bovis, • mard respiratorju tal- majjali (SRD) f’ majjali ikkawżat minn Actinobacillus
DRAXXIN is given as a single injection of 2.5 mg per kilogram body weight.
pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis.
In cattle, it is injected under the skin, and the dose is divided in cattle weighing over 300 kg so that no more than 7.5 ml are injected at one site.
Mycoplasma hyopneumoniae jew
In pigs it is injected into a muscle, and the dose is divided in pigs weighing over 80 kg so that no more than 2 ml are injected at one site.
DRAXXIN jista ’ jintuża wkoll biex jimpedixxi BRD u SRD.
If symptoms continue to be present, get worse or come back, treatment should be changed to another antibiotic.
Il- mediċini għandhom jintużaw biss għall- prevenzjoni fil- frat u majjali ladarba tkun ġiet stabbilita l- preżenza tal- marda fil - merħla, u għall- majjali jekk huma mistennija li jiżviluppaw il- marda fi żmien jumejn jew tliet ijiem.
The active substance in DRAXXIN, tulathromycin, is an antibiotic that belongs to the class ‘ macrolides’.
DRAXXIN jingħata bħala injezzjoni waħdanija ta ’ 2. 5 mg għal kull kilogramm tal- piż tal - ġisem.
It works by attaching to the RNA (the molecules that instruct the cell how to make proteins) within the bacterial cells.
Fil- frat, jiġi injettat taħt il- ġilda, u d- doża tiġi maqsuma fi frat li jiżnu aktar minn 300 kg sabiex mhux aktar minn 7. 5 ml jiġu injettati f’ sit wieħed.
This prevents the bacteria being able to make vital proteins and stops them growing and multiplying.
Fil- majjali, jiġi injettat f’ muskolu, u d- doża tiġi diviża f’ majjali li jiżnu aktar minn 80 kg sabiex mhux aktar minn 2 ml jiġu injettati f’ sit wieħed.
DRAXXIN is effective against the bacteria that most commonly cause BRD, SRD and IBK.
Huwa rrakkomandat li l- annimali jiġu ttrattati fil- fażijiet bikrin tal- marda u li r- rispons tagħhom jiġi evalwat fi żmien 48 siegħa.
However, some bacteria can develop resistance against tulathromycin, which will reduce its effectiveness.
Jekk is- sintomi jibqgħu preżenti, jiggravaw jew jerġgħu jffeġġu, it- trattament għandu jinbidel għal antibijotiku ieħor.
Reproduction is authorised provided the source is acknowledged How has DRAXXIN been studied?
Reproduction is authorised provided the source is acknowledged Kif jaħdem DRAXXIN?
The effectiveness of DRAXXIN in treating or preventing BRD has been studied in nine main studies involving calves, carried out during an outbreak of the disease.
L- effikaċja ta ’ DRAXXIN fit- trattament jew fil- prevenzjoni ta ’ BRD ġiet studjata f’ disa ’ studji prinċipali li jinvolvu għoġġiela, imwettqa matul tifqigħa tal- marda.
In the treatment studies, the cattle were infected with BRD-causing bacteria, but the cattle in the prevention studies had no symptoms of the disease.
Fl- istudji tat - trattament, il- frat kienu infettati bil- batterja li tikkawża l- BRD, iżda l- frat fl- istudji ta ’ prevenzjoni ma kellhom ebda sintomu tal- marda.
DRAXXIN was compared with tilmicosin or florfenicol (other antibiotics), and, in the prevention studies also with placebo (a dummy treatment).
DRAXXIN tqabbel ma ’ tilmicosin jew florfenicol (antibijotiċi oħrajn), u, fl- istudji ta ’ prevenzjoni ma ’ plaċebo wkoll (trattament finta).
The main measure of effectiveness was the change in symptoms, including body temperature, breathing and recovery over a period of between two weeks and two months.
Il- miżura ewlenija ta ’ l- effikaċja kienet il- bidla fis- sintomi, inkluż it- temperatura tal - ġisem, it- teħid tan- nifs u l- irkupru fuq perjodu ta ’ bejn ġimagħtejn u xahrejn.
For the treatment of IBK, the effectiveness of DRAXXIN has been studied in three main studies involving calves.
Għat- trattament ta ’ IBK, l- effikaċja ta ’ DRAXXIN ġiet studjata fi tliet studji prinċipali li jinvolu l- għoġġiela.
In two studies, it was compared with the effectiveness of placebo, but the third also compared it to oxytetracycline (another antibiotic).
F’ żewġ studji, ġie mqabbel ma ’ l- effikaċja ta ’ plaċebo, iżda t- tielet qabblu ma ’ oxytetracycline (antibijotiku ieħor).
The main measure of effectiveness was the proportion of cattle whose disease had been cured after three weeks.
Il- miżura ewlenija ta ’ l- effikkaċja kien il- proporzjon ta ’ frat li l- marda tagħhom ġiet ikkurata wara tliet ġimgħat.
The effectiveness of DRAXXIN in treating SRD has been studied in pigs in two main studies, where it was compared with tiamulin or florfenicol.
L- effkaċja ta ’ DRAXXIN fit- trattament ta ’ SRD ġiet studjata f’ majjali f’ żewġ studji prinċipali, fejn ġiet imqabbla ma ’ tiamulin jew florfenicol.
The main measure of effectiveness was the change in symptoms over 10 days.
Il- miżura ewlenija ta ’ l- effikaċja kienet il- bidla tas- sintomi fuq 10 t’ ijiem.
For the prevention of SRD, the effectiveness of DRAXXIN was studied in six main studies, in which it was compared with placebo.
Għall- prevenzjoni ta ’ SRD, l- effikaċja ta ’ DRAXXIN ġiet studjata f’ sitt studji prinċipali, li fih ġie mqabbel ma ’ plaċebo.
The main measure of effectiveness was the proportion of pigs that completed the full three or six weeks of each study without needing to be removed from the study because of SRD.
Il- miżura ewlenija ta ’ l- effikkaċja kienet il- proporzjon ta ’ majjali li temmew it- tliet jew is- sitt ġimgħat sħaħ ta ’ kull studju mingħajr il- ħtieġa li jitneħħew mill- istudju minħabba SRD.
What benefit has DRAXXIN shown during the studies?
X’ inhu l- benefiċċju li wera DRAXXIN tul l- istudji?
A single 2.5-mg/ kg dose of DRAXXIN was effective in treating and preventing BRD in cattle and SRD in pigs.
Doża singola ta ’ 2. 5- mg/ kg ta ’ DRAXXIN kienet effettiva fit- trattament u fil- prevenzjoni ta ’ BRD fil- frat u SRD fil- majjali.
In all studies, DRAXXIN was at least as effective as the comparator medicines.
Fl- istudji kollha, DRAXXIN kien għallinqas effettiv daqs il - mediċini komparaturi.