qanastek/EMEA-V3 huggingface dataset:
To indicate and to substantiate where necessary, any differences between Solacyl 100% powder and the reference product that could justify different conclusions on the efficacy for the two products.
Jindika u jissostanzja fejn meħtieġ, id- differenzi kollha bejn it- trab ta ’ Solacyl 100% u l- prodott ta ’ referenza li jistgħu jiġġustifikaw il- konklużjonijiet differenti fuq l- effikaċja taż- żewġ prodotti.
In response to question 1, the applicant provided a copy of the original dossier as submitted in support of the application of a decentralised procedure, and the supplementary data submitted during the decentralised procedure in response to the phase I and phase II assessment and the referral procedure in CMD(v) thereafter.
Bi tweġiba għall- mistoqsija numru 1, l- applikant ipprovda kopja tad- dossier oriġinali kif ippreżentat b’ appoġġ għall- applikazzjoni tal- proċedura ta ’ proċedura deċentralizzata, u d- dejta supplimentari ppreżentata waqt il- proċedura deċentralizzata bi tweġiba għall- valutazzjoni tal- fażi I u tal- fażi II u l - proċedura ta ’ riferiment fis- CMD( v) wara dan.
In response to question 2, the applicant answered that Solacyl 100% powder for oral solution is identical to the reference product and that there is no reason to reach different conclusions on the efficacy of the two products.
Bi tweġiba għall- mistoqsija numru 2, l- applikant wieġeb li t- trab għas- soluzzjoni orali Solacyl 100% huwa identiku għall- prodott ta ’ referenza u li ma hemm l- ebda raġuni biex wieħed jasal għal konklużjonijiet differenti fuq l- effikaċja taż- żewġ prodotti.
Solacyl 100% powder for oral solution proved to be essentially similar to the reference product, Natrium salicylaat 100%.
Ġie ppruvat li t- trab ta ’ Solacyl 100% għas- soluzzjoni orali kien essenzjalment simili għall- prodott ta ’ referenza, Natrium salicylaat 100%.
Consequently, the same conclusions on efficacy and safety apply to both products.
Konsegwentament, japplikaw l- istess konklużjonijiet għall - effikaċja u s- sigurtà għaż- żewġ prodotti.
The objections raised by Ireland should not prevent the granting of a marketing authorisation for Solacyl 100% powder for oral solution for calves and pigs.
L- objezzjonijiet imqajma mill- Irlanda m’ għandhomx jipprevjenu l- għoti ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għal Solacyl 100% trab għas- soluzzjoni għall- għoġġiela u l- majjali.
It is recommended that Solacyl 100% powder for oral solution for calves and pigs should follow the outcome of the Community Referral according to Article 35(2) for sodium salicylate-containing oral soluble powders.
Huwa rakkomandat li t- trab għas- soluzzjoni Solacyl 100% għall- għoġġiela u l- majjali isegwi r- riżultat tar- Riferiment tal- Komunità skond l- Artikolu għal trabijiet orali li jinħallu fl- ilma li fihom is- sodium salicylate.
6/ 7 The valid Summary of Product Characteristics, labelling and package leaflet are the versions agreed by the Reference Member State and Concerned Member States (except Ireland) at day 210 of the decentralised procedure.
6/ 7 Is- Sommarju tal- Karatteristiċi tal- Prodott, it- tikketta u l- fuljett ta ’ tagħrif huma l- verżjonijiet li sar qbil fuqhom mill- Istati Membri ta ’ Referenza u l- Istati Membri Konċernati (ħlief l- Irlanda) fil- 210 jum tal - proċedura ta ’ għarfien reċiproku
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ANIMAL SPECIES, FREQUENCY AND ROUTES OF ADMINISTRATION, RECOMMENDED DOSES, WITHDRAWAL PERIODS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES CONCERNED BY THE REFERRAL
LISTA TA ’ L- ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA, SPEĊI TA ’ ANNIMAL, FREKWENZA U MNEJN JINGĦATA, DOŻI RAKKOMANDATI, PERJODI TA ’ RTIRAR U DETENTURI TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ FL- ISTATI MEMBRI KONĊERNATI BIR- RIFERIMENT
EMEA/ CVMP/ 283947/ 2008-EN
EMEA/ CVMP/ 283947/ 2008- MT
June 2008
Ġunju 2008
Marketing
Detentur ta ’ l -
Animal species
Speċi ta ’
Frequency and
Frekwenza u
Withdrawal period
Perjodu ta ’ rtirar
Authorisation
Awtorizzazzjoni
form
farmaċewtika
route of
annimal
(meat and milk)
mnejn jingħata
administration
(laħam u ħalib)
Czech Republic
għat- Tqegħid fs- Suq Ir - Repubblika Ċeka
1ere Avenue 2056 M Lid 06516 Carros Cedex France
1ere Avenue 2056 M Lid 06516 Carros Cedex
Cattle, pigs
Frat, majjali
Two intramuscular injections at 48 hours interval
Żewġ injezzjonijiet ġol- muskoli b’ intervall ta ’ 48
15 mg amoxicillin/ kg bw (equivalent to 1ml/ 10 kg)
15 mg amoxicillin/ kg toqol (ekwivalenti għal 1ml/ 10 kg)
Meat and offal:
Laħam u ġewwieni:
Cattle:
Frat:
58 days Pigs:
58 jum Majjali:
35 days Milk:
35 jum
2.5 days
2. 5 jiem
Spain1
Spanja1
1ere Avenue 2056 M Lid 06516 Carros Cedex France
1ere Avenue 2056 M Lid 06516 Carros Cedex Franza
Two intramuscular injections at 48 hours interval
Żewġ injezzjonijiet ġol- muskoli b’ intervall ta ’ 48 siegħa bejniethom
35 days Milk:
35 jum Ħalib:
France2
Franza2
Two intramuscular injections at 48 hours interval
Żewġ
15 mg amoxicillin/ kg bw (equivalent to 1ml/ 10 kg)
15 mg amoxicillin/ kg
58 days Pigs:
58 jum
1 Marketing Authorisation not granted 2 Reference Member State for the Mutual recognition Procedure
1 Awtorizzazzjoni għal tqegħid fis- suq mhux mogħtija 2 Stat Membru ta ’ Riferenza għall- Proċedura ta ’ Rikonoxximent Reċiproku
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF RESIDUE DATA FOR SURAMOX 15% LA AND ITS ASSOCIATED NAME STABOX 15% LA, SUBMITTED TO THE CVMP AS A FOLLOW-UP OF AN ARTICLE 35 REFERRAL, FOR LIFTING THE SUSPENSION OF THE MARKETING AUTHORISATIONS
ĠABRA FIL- QOSOR ĠENERALI TAL- VALUTAZZJONI XJENTIFIKA TAD- DATA DWAR RESIDWI GĦAL SURAMOX 15% LA U L- ISEM ASSOĊJAT TIEGĦU STABOX 15% LA, SOTTOMESSA LIS- CVMP BIEX ISEGWI RIFERIMENT TAĦT L- ARTIKOLU 35, GĦAT- TNEĦĦIJA TAS- SOSPENSJONI TA ’ L- AWTORIZZAZZJONIJIET GĦAT - TQEGĦID FIS- SUQ
Suramox 15% LA and its associated name Stabox 15% LA is presented as an injectable suspension containing amoxicillin, which is a β -lactam antibiotic, belonging to the group of penicillins intended for the treatment of respiratory infections caused by Pasteurella multocida and Mannheimia haemolytica in cattle and for the treatment of respiratory infections due to Pasteurella multocida in pigs.
Suramox 15% LA u l- isem assoċjat tiegħu Stabox 15% LA hu ppreżentat bħala sospensjoni għall - injezzjoni li fiha amoxicillin, li hu antibijotiku β- lactam, li jagħmel parti mill- grupp ta ’ peniċillini intiżi għall- kura ta ’ infezzjonijet respiratorji kkawżati minn Pasteurella multocida u Mannheimia haemolytica fl- ifrat u għall- kura ta ’ infezzjonijiet respiratorji kkawżati mill- Pasteurella multocida fil - majjali.
In both species the product is administered intramuscularly at a dose rate of 15 mg amoxicillin/ kg bw (equivalent to 1 ml of Suramox 15% LA/ 10 kg bw) twice at 48 hours interval.
Fiż- żewġ speċi, il- prodott jingħata fil- muskolu b’ rata ta ’ 15- il mg amoxicillin għal kull kilogramma piż (ekwivalenti għal 1 ml ta ’ Suramox 15% LA għal kull 10 kg piż) darbtejn b’ 48 siegħa bejniethom.
Amoxicillin was previously evaluated by the CVMP together with other penicillins, in order to establish maximum residue limits (MRLs).
Amoxicillin kien preċedentament ivvalutat mis- CVMP flimkien ma ’ peniċillini oħra, biex jiġu iffissati l- limiti massimi ta ’ residwi (MRLs).
However, an ADI for penicillins was not established.
Madankollu ma ġiex stabilit ADI għall- peniċillini.
Benzylpenicillin was considered by the Joint FAO/ WHO Expert Committee on Food Additives (JECFA) at its 36th meeting in 1990.
Benzylpenicillin ġie kkunsidrat mill- Kumitat Espert Konġunt ta ’ l- FAO/ WHO dwar l- Addittivi ta ’ l - Ikel (JECFA) fis- 36 laqgħa tiegħu fl- 1990.
Several cases of allergic reactions in humans following the ingestion of food containing penicillin residues were reviewed.
Ġew analizzati diversi każijiet ta ’ reazzjonijiet allerġiċi fil - bniedem wara l- konsum ta ’ ikel b’ residwi tal- peniċillina.
Reports of further cases, which were not available to JECFA, had also been reported in the published literature.
Fil- letteratura ppubblikata ġew irrappurtati wkoll iktar każijiet, li ma kinux disponibbli għall- JECFA.
It was evident that penicillin residues have caused allergic reactions in consumers and that some of these reactions have been serious.
Kien evidenti li r- residwi tal- peniċillina kkawżaw reazzjonijiet allerġiċi fil- konsumaturi u li wħud minnhom kienu serji.
Being aware of cases of allergic reactions at very low doses, JECFA recommended that the daily intake of benzylpenicillin from food be kept as low as practicable, and in any case below 30 µg parent drug per person.
Billi kien jaf b’ każijiet ta ’ reazzjonijiet allerġiċi f’ dożi baxxi ħafna, il- JECFA rrakkomanda li t- teħid ta ’ kuljum ta ’ benzylpenicillin mill- ikel jinżamm kemm jista ’ jkun baxx, u dejjem inqas minn 30 µg tal- mediċina oriġinali għal kull persuna.
In setting maximum residue limits (MRLs) for the penicillins, the CVMP adopted the same approach as the Joint FAO/ WHO Expert Committee on Food Additives (JECFA).
Waqt li ffissa l- limiti massimi ta ’ residwu (MRLs) għall- peniċillini, is- CVMP adotta l- istess strateġija bħall- Kumitat Espert Konġunt ta ’ l- FAO/ WHO dwar l- Addittivi ta ’ l- Ikel (JECFA).
The CVMP set MRLs such that consumer intake from all foods would not exceed this 30 µg threshold.
Is- CVMP iffissa l- MRLs b’ mod li l- ammont meħud mill- konsumatur mill- prodotti kollha ta ’ l- ikel ma jkunx jaqbeż it - 30 µg.
On this basis MRLs for amoxicillin and other penicillins were proposed by the CVMP, and amoxicillin is currently entered in Annex I of Council Regulation (EEC) No 2377/ 90, in accordance with the following table:
Abbażi ta ’ dan ġew proposti MRLs għal amoxicillin u peniċillini oħra mis- CVMP, u amoxicillin bħalissa hu inkluż fl- Anness I tar- Regolament tal- Kunsill (KEE) Nru 2377/ 90, skond din it- tabella:
Pharmacologically
MRLs
Marker
Sustanza
Animal
Residwu tal -
MRLs
Speċi ta ’ l -
Target
Tessut fil -
Other
Dispożizzjonijiet
active substance
farmakoloġikament attiva
residue
Markatur
species
annimal
tissue
mira
provisions
oħra
All food
L- ispeċi
Muscle
Muskolu
producing species
kollha li jipproduċu l - ikel
Fat Liver Kidney Milk
Xaħam Fwied Kliewi Ħalib
EMEA/ CVMP/ 283947/ 2008-EN 2.
EMEA/ CVMP/ 283947/ 2008- MT
In order to obtain the lifting of the suspension of the marketing authorisations for Suramox 15% LA and its associated name Stabox 15% LA, the marketing authorisation holder performed four new residue studies in cattle and five new residue studies in pigs.
Valutazzjoni ta ’ l- istudji dwar it- tneħħija tar- residwi Biex jikseb it- tneħħija tas- sospensjoni ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għal Suramox 15% LA u l- isem assoċjat tiegħu Stabox 15% LA, id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq wettaq erba ’ studji ġodda dwar residwi fl- ifrat u ħames studji ġodda dwar residwi fil- majjali.
2.1 Residue studies in cattle
2. 1 Studji dwar residwi fl- ifrat
The first residue depletion study in cattle was performed to identify the time points to be used in the pivotal residue depletion study.
L- ewwel studju dwar it- tnaqqis ta ’ residwi fl- ifrat sar biex jiġu identifikati l- punti taż- żmien li għandhom jintużaw fl- istudju ewlieni dwar tneħħija tar- residwi.
The results from the study were used to design the pivotal residue study to include time points at 7, 14, 46 and 57 days after the last injection.
Ir- riżultati mill- istudju ntużaw għat - tfassil ta ’ studju ewlieni dwar residwi biex jinkludi l- punti taż- żmien fis- 7, 14, 46 u 57 jum mill- aħħar injezzjoni.
600 to 692 kg) were used (eight males and eight females).
Fl- istudju ewlieni dwar residwi, intużaw annimali tqal (piż: bejn 600 u 692 kg) (tmienja rġiel u tmienja nisa).
The animals were given 15 mg amoxicillin/ kg bw corresponding to 1ml/ 10 kg bw which required 4 injections, three of which were the maximum volumes (20 ml) and the remaining given in the fourth injection.
L- annimali ngħataw 15- il mg amoxicillin/ kg piż li jikkorrespondu għal 1ml/ 10 kg piż li ħtieġu 4 injezzjonijiet, li tlieta minnhom ingħataw f’ volumi massimi (20 ml) u l- bqija ngħatat fir- raba ’ injezzjoni.
The dosage was repeated 48 hours later.
Id- doża ġiet ripetuta wara 48 siegħa.
The animals were slaughtered at 7, 14, 46 and 57 days after the final injection.
L- annimali nqatlu wara 7, 14, 46 u 57 jum mill - injezzjoni finali.
All samples were analysed for amoxicillin concentrations using a validated HPLC-MS/ MS method with a limit of quantification of 25 µg/ kg for all tissues.
Il- kampjuni kollha ġew analizzati għall- konċentrazzjoni ta ’ amoxicillin bl- użu ta ’ metodu ta ’ HPLC- MS/ MS validat b’ limitu ta ’ kwantifikazzjoni ta ’ 25 µg/ kg għat- tessuti kollha.
Residue levels in fat, liver, kidney and non-injection site muscle were below the limit of quantification from the first time point (7 days) with the exception of one kidney sample that contained residues at the level of the limit of quantification (25 µg/ kg).
Il - livelli ta ’ residwu fix- xaħam, fil- fwied, fil- kliewi u f’ muskoli li fihom ma ngħatatx injezzjoni kienu inqas mill- limitu ta ’ kwantifikazzjoni mill- ewwel punt ta ’ żmien (sebat ijiem) ħlief għal kampjun wieħed mill- kliewi li kien fih residwi fil- livell tal- limitu ta ’ kwantifikazzjoni (25 µg/ kg).
At the injection site, residues above the muscle MRLs were found in all three core samples at the last time point tested (57 days) and as a result two other residues studies measuring residue levels at 80 and 90 days were carried out.
Fis- sit ta ’ l - injezzjoni, instabu residwi ikbar mill- MRLs tal- muskolu fit- tliet kampjuni ewlenin kollha fl- aħħar punt ta ’ żmien ittestjat (57 jum) u minħabba f’ hekk saru żewġ studji oħra dwar residwi li kejlu l- livelli ta ’ residwu wara 80 u 90 jum.
In the complementary studies animals that were younger and weighed much less (211 to 249; 206 to 228 kg) were used; otherwise the studies were conducted similarly to the pivotal study.
Fl- istudji komplementari ntużaw annimali li kienu iżgħar u eħfef (bejn 211 u 249; bejn 206 u 228 kg); mill- bqija l- istudji tmexxew b’ mod simili għall- istudju ewlieni.
In view of the weight of the animals only one injection site sample (core plus surrounding) was available for analysis unlike in the pivotal study where there were three samples per animal.
Minħabba l- piż ta ’ l- annimali, kien hemm biss kampjun wieħed tas- sit ta ’ l- injezzjoni (il- qalba u madwara) għall- analiżi mhux bħal l - istudju ewlieni li fih kien hemm tliet kampjuni għal kull annimal.
The use of heavier animals would have given extra assurance about residues levels at the injection site and would have made all studies homogenous.
L- użu ta ’ annimali itqal kien jagħti iktar assigurazzjoni dwar il- livelli ta ’ residwi fis- sit ta ’ l- injezzjoni u kien jagħmel l- istudji kollha omoġenji.
However, there are data to show residue depletion from at least one injection site which received the maximum volume and therefore the studies could be accepted for the purposes of setting the meat withdrawal period in cattle.
Madankollu, hemm data li turi tneħħija ta ’ residwu minn ta ’ l- anqas sit wieħed ta ’ l - injezzjoni li jkun irċieva l- volum massimu u għalhekk l- istudji setgħu jiġu aċċettati għall- iskopijiet ta ’ l- iffissar tal- perjodu ta ’ irtirar mill- laħam fl- ifrat.
Residues from the core injection site and its surrounding also remained below the limit of detection of muscle (2.1 µg/ kg) in all samples after 80 days and three samples after 90 days with remaining one being below the limit of quantification (25 µg/ kg).
Ir- residwi mill- qalba tas- sit ta ’ l- injezzjoni u madwara baqgħu taħt il- limitu li jitkejjel fil- muskolu (2. 1 µg/ kg) fil- kampjuni kollha wara 80 jum u fi tliet kampjuni wara 90 jum u b’ wieħed minnhom jibqa ’ taħt il- limitu tal- kwantifikazzjoni (25 µg/ kg).
2.2 Determination of meat withdrawal periods for cattle
2. 2 Determinazzjoni tal- perjodi ta ’ irtirar mill- laħam fl- ifrat
Residue levels in kidney, fat, liver and non-injection site muscle were below their respective MRLs from the first time point (7 days) tested.
Il- livelli ta ’ residwu fil- kliewi, fix- xaħam, fil- fwied u fil- muskoli li fihom ma ngħatatx injezzjoni kienu inqas mill- MRLs rispettivi mill- ewwwel punt ta ’ żmien (sebat ijiem) li ġew ittestjati.
Using the ‘ alternative approach’ as stated in CVMP Note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/ CVMP/ 036/ 95) a withdrawal period of 8 days is obtained after adding 10% ‘ uncertainty factor’.
Bl- użu ta ’ l - ‘ istrateġija alternattiva ’ kif imsemmi fin- Nota ta ’ gwida tas- CVMP dwar l- istrateġija għall - armonizzazzjoni tal- perjodi ta ’ irtirar (EMEA/ CVMP/ 036/ 95) jinkiseb perjodu ta ’ irtirar ta ’ tmint ijiem wara ż- żieda ta ’ ‘ fattur ta ’ inċertezza ’ ta ’ 10%.
A withdrawal period of 88 days is therefore established for cattle.
Madankollu, il- perjodu ta ’ irtirar attwali għall- prodott għandu jiġi bbażat fuq ir- residwi fis- sit ta ’ l - injezzjoni.
EMEA/ CVMP/ 283947/ 2008-EN 2.3 Residue studies in pigs
EMEA/ CVMP/ 283947/ 2008- MT
The pilot residue depletion study in pigs was performed to identify the time points to be used in the pivotal residue depletion study.
L- ewwel punt ta ’ żmien fejn il- livelli ta ’ residwi waqgħu taħt l- MRLs rispettivi kien 80 jum f’ kull kampjun tas- sit ta ’ l- injezzjoni.
The results from the study were used to design the pivotal residue study to include time points at 7, 14, 21 and 27 days after the last injection.
Minħabba li hemm data f’ punt ta ’ żmien addizzjonali (90 jum) fejn ir- residwi kienu inqas mil- limitu ta ’ kwantifikazzjoni, ġie aċċettat il - ‘ fattur ta ’ inċertezza ’ ta ’ 10%.
In the pivotal residue study, heavy animals (body weight:
Fl- istudju ewlieni dwar residwi, intużaw annimali tqal (piż:
66 - 84.5 kg) were used (eight male and eight female).
66 - 84. 5 kg) (tmienja rġiel u tmienja nisa).
The animals were given 15 mg amoxicillin/ kg bw corresponding to 1ml/ 10 kg/ bw which required 2 injections, one of which was the maximum volume (5 ml) and the remaining given in the second injection.
L- annimali ngħataw 15- il mg amoxicillin/ kg piż li jikkorrespondu għal 1ml/ 10 kg piż li ħtieġu żewġ injezzjonijiet, li waħda minnhom kellha l- volum massimu (5 ml) u l- bqija ngħata fit- tieni injezzjoni.
Animals (2 male and 2 female) were slaughtered at 7, 14, 21 and 27 days after the final injection.
L- annimali (2 irġiel u 2 nisa) nqatlu wara 7, 14, 21 u 27 jum mill- injezzjoni finali.
All samples were analysed for amoxicillin concentrations using a validated HPLC-MS/ MS method with a limit of quantification of 25 µg/ kg for all tissues.
Il- kampjuni kollha ġew analizzati għall- konċentrazzjoni ta ’ amoxicillin bl- użu ta ’ metodu ta ’ HPLC- MS/ MS ivvalidat b’ limitu ta ’ kwantifikazzjoni ta ’ 25 µg/ kg għat- tessuti kollha.
Residue levels in fat+skin, liver and non injection site muscle were all below the limit of quantification from the first time point (7 days) with the exception of one kidney sample which had residues above the MRL at the first time point and another one above the Limit of quantification.
Il- livelli ta ’ residwu fix- xaħam u l- ġilda, fil- fwied, u f’ muskoli li fihom ma ngħatatx injezzjoni kienu inqas mill- limitu ta ’ kwantifikazzjoni mill- ewwel punt ta ’ żmien (sebat ijiem) ħlief għal kampjun wieħed mill- kliewi li kien fih residwi għola mill- MRL fl- ewwel punt ta ’ żmien u ieħor li kien għola mill- limitu ta ’ kwantifikazzjoni.
The other two kidney samples were below the limit of quantification (25 µg/ kg).
Iż- żewġ kampjuni l- oħra tal- kliewi kienu taħt il- limitu ta ’ kwantifikazzjoni (25 µg/ kg).
At the injection site residues above the muscle MRLs were found in at least one core sample at the last time point tested (27 days) and as a result three other residues studies measuring residue levels at 30, 36, 38 and 46 days were carried out.
Fis- sit ta ’ l- injezzjoni, instabu residwi għola mill- MRLs tal- muskolu f’ għallinqas kampjun wieħed mill- qalba fl- aħħar punt ta ’ żmien ittestjat (27 jum) u minħabba f’ hekk saru tliet studji oħra dwar residwi li kejlu l- livelli ta ’ residwu fit- 30, 36, 38 u 46 jum.
The three complementary studies were conducted similarly to the pivotal study but in one of the complementary studies animals were younger and weighing much less (53 to 59 kg) than the ones used in the other studies were used but they did all receive at least the maximum injection volume (5 ml).
It- tliet studji komplimentari twettqu b’ mod simili għall- istudju ewlieni iżda f’ wieħed mill- istudji komplimentari l- annimali kienu iżgħar u eħfef (bejn 53 u 59 kg) minn dawk użati fl- istudji l- oħra iżda kollha rċevew ta ’ l- anqas il- volum massimu ta ’ l- injezzjoni (5 ml).
With the exception of one animal after 36 days which had high residues (core sample 339.4 µg/ kg), residue levels were below the MRL after 30, 38 and 46 days.
Ħlief għal annimal wieħed li wara 36 jum kellu residwi għoljin (kampjun mill- qalba 339. 4 µg/ kg), il- livelli ta ’ residwu kienu inqas mill - MRL wara 30, 38 u 46 jum.
2.4 Determination of meat withdrawal periods for pigs
2. 4 Determinazzjoni tal- perjodi ta ’ irtirar mill- laħam fil- majjali
Residue levels in skin+fat, liver and non-injection site muscle were below their respective MRLs from the first time point (7 days) tested and for kidneys from the second time point (14 days).
Il- livelli ta ’ residwu fil- ġilda u x- xaħam, fil- fwied u fil- muskoli li fihom ma ngħatatx injezzjoni kienu inqas mill- MRLs rispettivi mill- ewwel punt ta ’ żmien ittestjat (sebat ijiem) u għall- kliewi mit- tieni punt ta ’ żmien (14- il jum).
Using the ‘ alternative approach’ as stated in CVMP Note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/ CVMP/ 036/ 95) a withdrawal period of 16 days is obtained after adding 10% ‘ uncertainty factor’.
Bl- użu ta ’ l - ‘ istrateġija alternattiva ’ kif imsemmi fin- Nota ta ’ gwida tas - CVMP dwar l- istrateġija għall- armonizzazzjoni tal- perjodi ta ’ irtirar (EMEA/ CVMP/ 036/ 95) jinkiseb perjodu ta ’ irtirar ta ’ 16- il jum wara ż- żieda ta ’ ‘ fattur ta ’ inċertezza ’ ta ’ 10%.
However, the actual withdrawal period for the product is to be based on the injection site residues.
Madankollu, il- perjodu ta ’ irtirar attwali għall- prodott għandu jiġi bbażat fuq ir- residwi fis- sit ta ’ l - injezzjoni.
The statistical approach could not be used for the calculation of the withdrawal period as the test for log-linearity (F-test) was not met and therefore the ‘ alternative approach ’ as set out in the CVMP guideline (EMEA/ CVMP/ 036/ 95-Final) was used.
L- istrateġija statistika ma setgħetx tintuża għall- kalkulazzjoni tal- perjodu ta ’ irtirar għax it- test tal- log - linearity (F- test) ma ntlaħaqx u għalhekk intużat l - ‘ istrateġija alternattiva ’ kif stipulata fil- linja gwida tas- CVMP (EMEA/ CVMP/ 036/ 95- Finali).
The first time point where residues fell below their respective MRLs was 38 days in all injection site samples.
L- ewwel punt ta ’ żmien fejn il- livelli ta ’ residwi waqgħu taħt l- MRLs rispettivi kien 38 jum f’ kull kampjun tas- sit ta ’ l- injezzjoni.
A safety span of 30% was considered necessary in this case because at the previous time point, which was only 2 days earlier, one sample contained residues of nearly 7 times the MRL.
F’ dan il- każ kienet meqjusa meħtieġa medda ta ’ sigurtà ta ’ 30% minħabba li fil- punt taż- żmien preċedenti, li kien biss jumejn qabel, kampjun wieħed kien fih reżidwi ta ’ kważi seba ’ darbiet iktar mill- MRL.
This leads to a withdrawal period of 50 days.
Dan iwassal għal perjodu ta ’ irtirar ta ’ 50 jum.
A withdrawal period of 50 days is therefore established for pigs.
Serħan il- moħħ akbar dwar l- adegwatezza ta ’ dan il- perjodu ta ’ irtirara
EMEA/ CVMP/ 283947/ 2008-EN 3.
EMEA/ CVMP/ 283947/ 2008- MT
Having considered the new residue depletion data provided for the lifting of the suspension of the marketing authorisations for Suramox 15% LA and its associated name Stabox 15% LA concerning the establishment of withdrawal periods for cattle and pigs, the CVMP concluded that:
Wara li kkunsidra d- data ġdida dwar it- tnaqqis tar- residwu pprovvduta għat- tneħħija tas- sospensjoni ta ’ l- awtorizzazzjonijiet għat- tqegħid fis- suq għal Suramox 15% LA u l- isem assoċjat tiegħu Stabox 15% LA dwar l- iffissar ta ’ perjodi ta ’ irtirar għall- ifrat u l- majjali, is- CVMP ikkonkluda li:
• the new residue depletion studies in both cattle and pigs are of an acceptable standard and in large part in accordance with CVMP guideline on injection site residues (EMEA/ CVMP/ 542/ 03); • time points where residues at the injection sites were below the muscle MRL were identified for both cattle and pigs; • A meat withdrawal period can be set in both cattle and pigs using the ‘ Alternative approach’ as stated in the CVMP Note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/ CVMP/ 036/ 95); • A meat withdrawal period of 88 days for cattle and 50 days for pigs can now be established;
• l- istudji l- ġodda ta ’ tnaqqis tar- residwu kemm fl- ifrat u kemm fil- majjali huma ta ’ standard aċċettabbli u fil- biċċa l- kbira konformi mal- linja gwida tas- CVMP dwar ir- residwi fis- sit ta ’ l - injezzjoni (EMEA/ CVMP/ 542/ 03); • għall- ifrat u l- majjali ġew identifikati punti ta ’ żmien li fihom ir- reżidwi fis- siti ta ’ l- injezzjoni kienu inqas mill- MRL tal- muskoli; • jista ’ jiġi stabbilit perjodu ta ’ irtirar għal- laħam kemm għall- ifrat kif ukoll għall- majjali bl- użu ta ’ ‘ Strateġija alternattiva ’ kif jingħad fin- Nota ta ’ gwida tas- CVMP dwar l- istrateġija għall - armonizzazzjoni tal- perjodi ta ’ irtirar (EMEA/ CVMP/ 036/ 95); • issa jista ’ jiġi iffissat perjodu ta ’ irtirar mill- laħam ta ’ 88 jum għall- ifrat u 50 jum għall- majjali;
Therefore, the Committee for Medicinal Products for Veterinary Use recommends to lift the suspension of the marketing authorisations for Suramox 15% LA and its associated name Stabox 15% LA and to vary the marketing authorisations in order to set the withdrawal periods as stated above.
Għalhekk, il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju jirrakkomanda t- tneħħija tas - sospensjoni ta ’ l- awtorizzazzjonijiet għat- tqegħid fis- suq għal Suramox 15% LA u l- isem assoċjat tiegħu Stabox 15% LA u l- varjazzjoni ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq sabiex jiġu iffissati l - perjodi ta ’ irtirar kif imsemmi hawn fuq.
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
KARATTERISTIĊI TAL- PRODOTT FIL- QOSOR TIKKETTA U L- FULJETT TA ’ TAGĦRIF FIL- PAKKETT
Suramox 15% LA, suspension for injection
Suramox 15% LA, suspensjoni għal injezzjoni
Each ml contains:
Kull milligramma tikkuntieni:
Micronised amoxicillin (as trihydrate)
Amoksiċillina mikronizzat (bħala tri- idrat)
Benzyl alcohol
Alkoħol benżil
For a full list of excipients, see section 6.1
Għal lista sħiħa ta ’ l- ingredjenti mhux attivi, ara s- sezzjoni 6. 1.
Suspension for injection
Suspensjoni għal injezzjoni
Cattle and pigs
Frat u majjali
4.2 Indications for use, specifying the target species
4. 2 Indikazzjonijiet għall- użu tal- prodott li jispeċifikaw l- ispeċi li fuqhom se jintuża l - prodott.
Treatment of respiratory infections due to Pasteurella multocida and Mannheimia haemolytica.
Kura ta ’ nfezzjonijiet respiratorji kawżati minn Pasteurella multoċida u Mannheimia emolitika.
Treatment of respiratory infections due to Pasteurella multocida.
Kura ta ’ nfezzjonijiet respiratorji kawżati minn Pasteurella multoċida.
Do not use in animals with known hypersensitivity to penicillin or other substances of the β -lactam group.
Tużax f’ annimali li għandhom sensittività eċċessiva magħrufa għall- peniċillina jew sustanzi oħra tal - grupp β- lactam.
Do not use in rabbits, guinea pigs, hamsters or gerbils.
Tużax fi fniek, fniek ta ’ l- Indi, ħamster u ġerbilli.
Do not use in case of known resistance to amoxicillin.
Tużax f’ każijiet ta ’ reżistenza magħrufa għall- amoksiċillina.
4.4 Special warnings for each target species
4. 4 Twissijiet speċjali għal kull speċi li fuqhom se jintuża l- prodott.
4.5 Special precautions for use
4. 5 Prekawzjonijiet Speċjali għall- Użu
Special precautions for use in animals
Prekawzjonijiet speċjali għall- użu fl- annimali
Strict aseptic precautions should be observed.
Prekawzjonijiet stretti asettiċi għandhom jiġu osservati..
In case of the occurrence of allergic reaction, the treatment should be immediately withdrawn.
F’ każ ta ’ okkorrenza ta ’ reazzjoni allerġika, il- kura għandha titwaqqaf immedjatament.
Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
L - użu mhux addattat tal- prodott jista ’ jżid il- prevalenza ta ’ batterji reżistenti għall- amoksiċillina.
Narrow spectrum antibacterial therapy should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.
L- użu tal- prodott għandu jkun ibbażat fuq it- test ta ’ suxxettibilità u jieħu f’ kunsiderazzjoni politiċi anti - mikrobiċi uffiċċjali u lokali.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact.
Peniċillini u ċefalosporini jistgħu jikkawżaw sensittività eċċessiva (allerġija) wara injezzjoni, inalazzjoni, inġestjoni jew kuntatt mal- ġilda.
Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins and vice versa.
Sensittività eċċessiva għall- peniċillini jistgħu jwasslu għal reazzjonijiet imħallta għaċ- ċefalosporini u viċi versa.
Allergic reactions to these substances may occasionally be serious.
Reazzjonijiet allerġiċi għal dawn is- sustanzi jistgħu kultant ikunu serji.
Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.
Tmissx dan il- prodott jekk taf li int issensibilizzata, jew jekk kont irrikmandat/ a biex ma taħdimx bi preparazzjonijiet bħal dawn.
In case of accidental contact with eyes, rinse immediately with copious amounts of water.
F’ każ ta ’ kuntatt bi żball ma ’ l- għajnejn, laħlaħ immedjatament b’ ammont abbundanti ta ’ ilma.
If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning.
Jekk tiżviluppa xi sintomi wara li tkun espost bħal raxx tal- ġilda, għandek tfittex parir mediku u turi dan l- avviż lit- tabib.
Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
Nefħa tal- wiċċ, xoffa jew għajnejn jew diffikultà tan- nifs huma sintomi aktar serji u jirrikjedu attenzjoni medika urġenti.
4.6 Adverse reactions (frequency and seriousness)
4.. 6 Effetti mhux mixtieqa (frekwenza u gravità)
Hypersensitity reactions unrelated to dose can be observed.
Reazzjonijiet ta ’ sensittività eċċessiva mhux relatati mad- doża għandhom ikunu osservati.
Allergic reactions, skin reactions, anaphylaxis) may occur.
Reazzjonijiet allerġiċi, reazzjonijiet tal- ġilda (analfilassi) jistgħu jseħħu.
4.7 Use during pregnancy, lactation or lay
4. 7 Użu fit- Tqala, fit- Treddiegħ u meta jbidu l- bajd
Studies performed in laboratory animals (rat, rabbit), did not show a teratogenic, embryotoxic or maternotoxic effect of amoxicillin.
Studji magħmulin fl- annimali tal- laboratorju (far, fenek), ma wrewx effetti teratoġeniċi, embijotossiċi jew meternotossiċi ta ’ amoksiċillina.
The safety of the product has not been assessed in pregnant and lactating targets species.
Is- sigurtà tal- prodott ma ġiex valutat fi speċi tqal u dawk li qed ireddgħu li fuqhom se jintuża l- prodott.
Use in such cases only according to the benefit/ risk assessment by the responsible veterinarian.
F’ każijiet bħal dawn uża biss skond il- valutazzjoni benefiċċju/ riskju mill- veterinarju responsabbli.
The bactericidal effect of amoxicillin is neutralised by simultaneous use of bacteriostatic acting pharmaceuticals (macrolides, sulphonamides and tetracyclines).
L- effett batteriċidali ta ’ l- amoksiċillina hu newtralizzat mill- użu simultanju ta ’ aġenti farmaċewtiċi batterjostatiċi (makrolidi, sulfonamidi u tetraċiklini).
Intramuscular injection (cattle, pigs).
Injezzjoni intramuskolari (frat, majjali).
Cattle and pigs:
Frat u majjali:
Administer 15 mg amoxicillin (as trihydrate) per kg bodyweight equivalent to 1 ml per 10 kg, twice at 48 hours interval.
Amministra 15 mg amoksiċillina (bħala tri- idrat) għal kull kilogramm piż tal- ġisem ekwivalenti għal 1 ml għal kull 10 kg, darbtejn f’ intervall ta ’ 48 siegħa.
It is recommended that the maximum volume administered per site of injection should not exceed 20 ml in cattle and 5 ml in swine.
Hu rrikmandat li l- volum massimu amministrat għal kull sit ta ’ l- injezzjoni m’ għandux jaqbeż l- 20 ml fl- ifrat u l- 5 ml fil- majjali.
No information is available.
M’ hemmx informazzjoni disponibbli.
EMEA/ CVMP/ 283947/ 2008-EN 4.11 Withdrawal period(s)
EMEA/ CVMP/ 283947/ 2008- MT 4. 11 Perjodu ta 'Tiżmim
Meat and offal: - Cattle:
Laħam u ġewwieni ta ’ l- annimali: - Frat:
88 days - Pigs:
88 ġurnata - Majjali:
50 days
50 ġurnata
- Milk:
- Ħalib:
2.5 days
2. 5 ġurnata
Pharmacotherapeutic group:
Grupp farmako- terapewtiku:
Penicillins with extended spectrum ATCVet code:
Peniċillini b’ spettru mtawwal Kodici ATĊ veterinarja:
Amoxicillin belongs to β -lactams antibiotic family.
Amoksiċillina jappartieni lill- familja antibijotika tat- tip β- lactam.
Its structure contains the β -lactam ring and thiazolidine ring common to all penicillins.
L- istruttura tikkuntieni ċ- ċirku β - lactam u ċ- ċirku tiażolidine komuni għall- peniċillini kollha.
Amoxicillin is active against susceptible Gram positive and Gram negative bacteria.
Amoksiċillina hu attiv kontra batterji suxxettibbli Gram pożittiv u Gram negattiv.
β -lactam antibiotics prevent the bacterial cell wall synthesis by interfering with the final stage of peptidoglycan synthesis.
L- antibijotiċi β- lactam jimpedixxu s- sintesi tal- ħajt taċ- ċellula batterjali billi jindaħħlu ma ’ l- aħħar fażi tas- sintesi peptidoglikan.
They inhibit the activity of transpeptidase enzymes which catalyse cross- linkage of the glycopeptide polymer units that form the cell wall.
Huma jimpedixxu l- attività ta ’ l- enzimi transpeptidasi li jikkatalizzaw tagħqid imħallat ta ’ l- unitajiet ta ’ polimer glikopeptide li jiffurmaw il- ħajt taċ- ċellula.
They exert a bactericidal action on growing cells only.
Huma jeżerċitaw azzjoni batteriċidali fuq iċ- ċelluli li qed jikbru biss.
Amoxicillin is susceptible to breakdown by ß-lactamases produced by some bacterial strains.
Amoksiċillina hu suxxettibbli li jinqasam minn ß- lactamasi li huma prodotti minn xi tensjonijiet batterjali.
Another possible mode of resistance to β -lactam antibiotics can be associated with chromosomal mutations in bacteria resulting either in modification of the penicillin binding proteins (PBPs) or in modification of the cellular permeability to β -lactams.
Mod ieħor possibbli ta ’ reżistenza għall- antibijotiċi β- lactam jista ’ jkun assoċjat b’ tibdiliet kromosonali fil- batterji li jirriżultaw jew f’ modifikazzjoni tal- proteini magħquda bil- peniċillina (PBPs) jew f’ modifikazzjoni tal- permeabbiltà ċellulari għal β- lactams.
By their nature such chromosomal mutations tend to be relatively slow in developing and occur primarily by vertical transmission.
Bin- natura tagħhom tibdiliet kromosonali bħal dawn għandhom tendenza li jiżviluppaw relattivament bil- mod u jseħħu primarjament b’ trasmissjoni vertikali.
Escherichia coli resistance has been reported.
Reżistenza għal Escherichia coli resistance ġiet irrapurtata.
After intramuscular administration amoxicillin is well absorbed and distributed in the tissues.
Wara li l- amministrazzjoni intramuskolari l- amoksiċillina tiġi assorbita sew u mqassma ġot- tessut.
After a single intramuscular administration of the product at 15 mg/ kg to pigs, mean amoxicillin plasma peak concentration of 3.78 µg/ ml is reached 0.77 hours after dosing.
Wara amministrazzjoni intramuskolari waħda tal- prodott b’ doża ta ’ 15mg għal kull 1kg lil majjali, il - konċentrazzjoni massima fil- plażma medja ta ’ 3. 78 µg għal kull milligram tintlaħaq 0. 77 siegħa wara l- amministrazzjoni tad- doża.
The mean half-life of elimination is 7 hours.
Iż- żmien medju ta ’ l- eliminazzjoni biex jinżel għal nofs il- valur tiegħu hu ta ’ 7 siegħat.
After a single intramuscular administration of the product at 15 mg/ kg to cattle, mean amoxicillin plasma peak concentration of 2.93 µg/ ml is reached 1.64 hours after dosing.
Wara amministrazzjoni intramuskolari waħda tal- prodott b’ doża ta ’ 15mg għal kull 1kg lill- ifrat, il - konċentrazzjoni massima fil- plażma medja ta ’ 2. 93 µg għal kull milligram tintlaħaq 1. 64 siegħa wara l- amministrazzjoni tad- doża.
The main elimination route of amoxicillin is via urine.
Iż- żmien medju ta ’ l- eliminazzjoni biex jinżel għal nofs il- valur tiegħu hu ta ’ 12- il siegħa.
Benzyl alcohol Stearic acid Aluminium stearate Propylene glycol dicaprylate/ dicaprate
Ir- rotta ewlenija ta ’ l- eliminazzjoni ta ’ l- amoksiċillina hi vija l- awrina.
EMEA/ CVMP/ 283947/ 2008-EN 6.2 Incompatibilities
TAGĦRIF FARMAĊEWTIKU 6. 1 Lista ta ’ ingredjenti mhux attivi
6.3 Shelf life
Mhux applikabbli
Shelf-life after first opening the container:
Żmien li l- prodott jibqa 'tajjeb wara li l- ewwel jinfetaħ il- kontenitur:
28 days.
28 ġurnata.
Special precautions for storage
Tagħrif speċjali dwar kif għandu jinħażen
This veterinary medicinal product does not require any special storage conditions required.
Dan il- prodott mediċinali veterinarju m’ għandux bżonn ta ’ l- ebda kondizzjoni speċjali sabiex jinħażen
6.5 Nature and composition of immediate packaging
6. 5 In- natura u l- għamla ta ’ l- ewwel ippakkjar
Polyethylene terephtalate (PET) bottles with rubber closures and aluminium capsules
Fliexken tal- Polietilene tereftalat (PET) b’ tappijiet tal- gomma u kapsuli ta ’ l- aluminju.
Product presentations:
Preżentazzjoni tal- prodott:
Box of 125 ml bottle Box of 250 ml bottle Box of 500 ml bottle
Kaxxa ta ’ fliexken ta ’ 125 ml Kaxxa ta ’ fliexken ta ’ 250 ml Kaxxa ta ’ fliexken ta ’ 500 ml
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użati jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Kull prodott mediċinali veterinarju li ma ġiex użat jew prodotti oħra li ntużaw għal din il- mediċina veterinarja għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
06516 CARROS CEDEX FRANCE
06516 CARROS CEDEX FRANZA
< {DD/MM/YYYY} > < {DD month YYYY} >
< {DD/ MM/ YYYY} > < {DD/ month/ YYYY} >
10 DATE OF REVISION OF THE TEXT
10 DATA TA ’ META ĠIET RIVEDUTA DIN IL- KITBA
{MM/ YYYY} or< month YYYY >
{MM/ YYYY} > jew < month YYYY} >
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
BOX of 125, 250 or 500 ml
KAXXA ta ’ 125, 250 jew 500 ml
Suramox 15% LA, suspension for injection Amoxicillin
Suramox 15% LA, suspensjoni għal injezzjoni Amoksiċillina
Micronised amoxicillin (as trihydrate) 150.0 mg/ ml Excipient:
Amoksiċillina mikronizzat (bħala tri- idrat) 150. 0 mg Sustanza mhux attiva:
Benzyl alcohol 35.0 mg/ ml
Alkoħol benżil 35. 0 mg/ ml
TARGET SPECIES
SPEĊI GĦAL LIEMA HUWA INDIKAT IL- PRODOTT
Intramuscular injection (cattle, pigs).
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett Injezzjoni intramuskolari (frat, majjali).
Administer 15 mg amoxicillin (as trihydrate) per kg bodyweight equivalent to 1 ml per 10 kg, twice at 48 hours interval.
Amministra 15 mg amoksiċillina (bħala tri- idrat) għal kull kilogrammm piż tal- ġisem ekwivalenti għal 1 ml għal kull 10 kg, darbtejn f’ intervall ta ’ 48 siegħa.
It is recommended that the maximum volume administered per site of injection should not exceed 20 ml in cattle and 5 ml in swine.
Hu rrikmandat li l- volum massimu amministrat għal kull sit ta ’ l- injezzjoni m’ għandux jaqbeż l- 20 ml fl- ifrat u l- 5 ml fil- majjali..
Meat and offal: - Cattle: - Pigs:
Laħam u ġewwieni ta ’ l- annimali: - Frat: - Majjali:
88 days 50 days
88 ġurnata 50 ġurnata
EMEA/ CVMP/ 283947/ 2008-EN 9.
EMEA/ CVMP/ 283947/ 2008- MT 9.
Accidental injection is dangerous – see package leaflet before use.
Jekk tinjetta bi żball huwa perikoluż – aqra l- fuljett ta 'tagħrif fil- pakkett qabel l- użu.
< EXP {month/year} > Shelf-life after first opening the container:
< Jiskadi {xahar / sena} > Iż- żmien kemm idum tajjeb il- prodott wara li jinfetaħ il- kontenitur għall- ewwel darba:
28 days
28 ġurnata.
This veterinary medicinal product does not require any special storage conditions required.
Dan il- prodott mediċinali veterinarju m’ għandux bżonn ta ’ kondizzjonijiet ta ’ ħażna speċjali
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA 'PRODOTTI MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI, jekk ikun il- każ.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM "GĦAL KURA 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 kura ta ’ l- annimali biss - għandu jingħata biss bi preskrizzjoni veterinarja.
MARKETING AUTHORISATION NUMBER(S)
NUMRU/ I TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
< Batch > < Lot > < BN > {number}
< Lott > < lott > < Numru tal- lott > {numru}
EMEA/ CVMP/ 283947/ 2008-EN PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
EMEA/ CVMP/ 283947/ 2008- MT TAGĦRIF LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI
Bottle of 125, 250 or 500 ml
Flixkun ta ’ 125, 250 jew 500 ml
Suramox 15% LA, suspension for injection Amoxicillin
Suramox 15% LA, suspensjoni għall- injezzjoni Amoksiċillina
QUANTITY OF THE ACTIVE SUBSTANCE(S)
KWANTITÀ TAS- SUSTANZA ATTIVA / SUSTANZI ATTIVI
Micronised amoxicillin (as trihydrate) 150.0 mg/ ml
Amoksiċillina mikronizzat (bħala tri- idrat)
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
KONTENUT BĦALA/ SKOND IL- PIŻ, IL- VOLUM JEW IN- NUMRU TA 'DOŻI
Bottle of 125, 250 or 500 ml.
Flixkun ta ’ 125, 250 jew 500 ml.
ROUTE(S) OF ADMINISTRATION
MOD( I) TA ’ AMMINISTRAZZJONI
Intramuscular injection
Injezzjoni intramuskolari
THE WORDS “ FOR ANIMAL TREATMENT ONLY”
IL- KLIEM "GĦAL KURA TA ’ L- ANNIMALI BISS ”
For animal treatment only.
Għal kura ta ’ l- annimali biss
PACKAGE LEAFLET
FULJETT TA ’ TAGĦRIF FIL- PAKKETT
June 2008 PACKAGE LEAFLET
Ġunju 2008
Suramox 15% LA, suspension for injection
FULJETT TA ’ TAGĦRIF FIL- PAKKETT Suramox 15% LA, suspensjoni għal injezzjoni
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
L- ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ U TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L- KONSENJA TMUR FIS- SUQ, JEKK DIFFERENTI
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA( I) U INGREDJENT( I) OĦRA
Micronised amoxicillin (as trihydrate) 150.0 mg/ ml Excipient:
Amoksiċillina mikronizzat (bħala tri- idrat) 150. 0 mg/ ml Sustanza mhux attiva:
INDICATION(S)
INDIKAZZJONI (JIET)
CONTRAINDICATIONS
KONTRA- INDIKAZZJONIJIET
Do not use in case of known resistance to amoxicillin
Tużax f’ każijiet ta ’ reżistenza magħrufa għall- amoksiċillina.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Jekk tinnota xi effetti serji jew effetti oħra mhux imsemmija f’ dan il- fuljett, jekk jogħġbok informa l - kirurgu veterinarju tiegħek.
TARGET SPECIES
SPEĊI LI GĦALIHOM HUWA INDIKAT IL- PRODOTT
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
DOŻAĠĠ GĦAL KULL SPEĊI, MOD( I) U METODU TA 'AMMINISTRAZZJONI
ADVICE ON CORRECT ADMINISTRATION
PARIR SABIEX TAMMINISTRA B' MOD KORRETT
It is recommended that the maximum volume administered per site of injection should not exceed 20 ml in cattle and 5 ml in swine.
Hu rrikmandat li l- volum massimu ammininistrat 20 ml fl- ifrat u l- 5 ml fil- majjali.
WITHDRAWAL PERIOD
PERJODU TA 'TIŻMIM
Shelf-life after first opening the container:
Iż- żmien kemm idum tajjeb il- prodott wara li jinfetaħ il- kontenitur għall- ewwel darba:
SPECIAL WARNING(S)
TWISSIJA( IJIET) SPEĊJALI
Strict aseptic precautions should be observed.
Prekawzjonijiet stretti mhux settiċi għandhom jiġu osservati..
In animals with hepatic and renal failure, the dosage regimen should be carefully evaluated.
F’ annimali b’ falliment epatiku u renali, il- programm tad- dożaġġ għandu jkun evalwat b’ attenzjoni.
Inappropriate use of the product may increase the prevalence of bacteria resistant to amoxicillin.
L - użu mhux addattat tal- prodott jista ’ jżid il- prevalenza ta ’ batterji reżistenti għall- amoksiċillina.
Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
L- użu tal- prodott għandu jkun ibbażat fuq it- test ta ’ suxxettibilità u jieħu f’ kunsiderazzjoni politiċi anti - mikrobiċi uffiċċjali u lokali.
Narrow spectrum antibacterial therapy should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.
Terapija anti- batterjali b’ spettru dejjaq għandha tkun użata għall- ewwel linja tal- kura fejn fuq it- test ta ’ suxxettibilità jissuġġerixxi l- effikaċja probabbli għal dan l- approwċ.
If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning.
Jekk tiżviluppa xi sintomi wara lit kun espost bħal raxx tal- ġilda, għandek tfittex parir mediku u turi dan l- avviż lit- tabib.
Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
Studji magħmulin fl- annimali tal- laboratorju (far, fenek), ma wrewx effetti teratoġeniċi, embijotossiċi jew meternotossiċi ta ’ amoksiċillina.
EMEA/ CVMP/ 283947/ 2008-EN Use during pregnancy or lactation
EMEA/ CVMP/ 283947/ 2008- MT
Use in such cases only according to the benefit/ risk assessment by the responsible veterinarian.
Effetti fuq prodotti mediċinali oħra jew effetti oħra
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR RIMI TA 'PRODOTT MHUX UŻAT JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
Not all pack sizes may be marketed.
Mhux id- daqsijiet kollha tal- pakketti jistgħu jkunu fis- suq.
London, 5 September 2008 EMEA/ 344321/ 2008
Londra, 5 ta ’ Settembru 2008 EMEA/ 344321/ 2008
COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)
KUMITAT GHAL PRODOTTI MEDIĊINALI GĦALL- UŻU VETERINARJU (CVMP)
FOLLOW-UP OPINION FOLLOWING AN ARTICLE 351 REFERRAL FOR Suramox 15% LA and its associated name Stabox 15% LA International Non-Proprietary Name (INN):
OPINJONI TA ’ SEGWITU WARA RIFERIMENT TAĦT L- ARTIKOLU 351 GĦAL Suramox 15% LA u l- isem assoċjat tiegħu Stabox 15% LA Denominazzjoni Komuni Internazzjonali (DKK):
BACKGROUND INFORMATION (2)
INFORMAZZJONI ĠENERALI (2)
Suramox 15% LA is an injectable suspension containing amoxicillin, which is a beta-lactam antibiotic belonging to the penicillin group.
Suramox 15% LA huwa sospensjoni għall- injezzjoni li fiha amoxicillin, li huwa antibijotiku beta - lactam, li jagħmel parti mill- grupp ta ’ peniċillini.
The product is used in the treatment of respiratory infections caused by Pasteurella multocida and Mannheimia haemolytica in cattle and for the treatment of respiratory infections due to Pasteurella multocida in pigs.
Il- prodott jintuża għall- kura ta ’ infezzjonijiet respiratorji kkawżati minn Pasteurella multocida u Mannheimia haemolytica fl- ifrat u għall- kura ta ’ infezzjonijiet respiratorji dovuti għal Pasteurella multocida fil- majjali.