qanastek/EMEA-V3 huggingface dataset:
Having considered the grounds for referral and the responses provided by the Marketing Authorisation Holder, CVMP concludes that the benefit/ risk balance of the product is positive for use in both pigs and broilers subject to the recommended changes to Summary of the Product Characteristics and product information.
Meta kkunsidra r- raġunijiet għar- referenza u r- reazzjonijiet ipprovduti mid- Detentur ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq, is- CVMP ikkonkluda li l- bilanċ tar- riskju/ benefiċċju tal - prodott huwa wieħed pożittiv għal użu kemm fil- ħnieżer kif ukoll fil- brojlers soġġetti għat- tibdil irrikmandat għas- Sommarju tal- Karatteristiċi tal- Prodott u tagħrif dwar il- prodott.
9/ 19 ANNEX III
10/ 20 ANNESS III
SUMMARY OF PRODUCT CHARACTERISTICS AND IMMEDIATE PACKAGING
KARATTERISTIĊI TAL- PRODOTT FIL- QOSOR U IPPAKKJAR PRIMARJU
10/ 19 SUMMARY OF PRODUCT CHARACTERISTICS
11/ 20 KARATTERISTIĊI TAL- PRODOTT FIL- QOSOR
11/ 19 1.
12/ 20 1.
Methoxasol-T oral solution for pigs and broilers
Methoxasol- T soluzjoni orali għall- ħnieżer u brojlerijiet
Active substances:
Sustanzi Attivi:
Per ml solution
Kull ml ta ’ soluzjoni
20.0 mg
20. 0 mg
100.0 mg
100. 0 mg
Excipients:
Ingredjenti:
N-methyl-pyrrolidone
N- methyl- pyrrolidone
For a full list of excipients, see section 6.1.
Għal- lista sħiħa ta ’ l- ingredjenti, ara s- sezzjoni 6. 1.
Solution for oral administration.
Soluzjoni għall- amministrazzjoni orali.
Clear and yellow
Ċar u isfar
CLINICAL PARTICULARS
4 TAGĦRIF KLINIKU
4.1 Target species
4. 1 Speċi li fuqhom ser jintuża l- prodott
Pigs and broilers.
Ħnieżer u brojlerijiet
4.2 Indications for use, specifying the target species
4. 2 Indikazzjonijiet għal użu tal- prodott li jispeċifikaw l- ispeċi li fuqhom se jintuża l- prodott.
Pigs:
Il- ħnieżer:
Treatment and prevention of respiratory infections caused by Actinobacillus pleuropneumoniae susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the herd.
Trattament u prevenzjoni ta 'infezzjonijiet respiratorji kkawżati minn Actinobacillus pleuropneumoniae suxxettibbli għat- trimethoprim u s- sulfamethoxazole fejn il- marda instabet fil - merħla.
Broilers:
Il- brojlerijiet:
Treatment and prevention of respiratory infections caused by Escherichia coli susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the flock.
Trattament u prevenzjoni ta 'infezzjonijiet respiratorji kkawżati minn Escherichia coli suxxettibbli għat- trimethoprim u s- sulfamethoxazole fejn il- marda instabet fil- merħla.
Resistance against potentiated sulphonamides may vary.
Ir- reżistenza kontra s- sulfonamidi potenzjali tista ’ tvarja.
Therefore the use of the product should be based on culture and sensitivity of micro-organisms from diseased cases on farm or from recent previous experience on the farm.
Għalhekk l- użu tal- prodott għandu jkun ibbażat fuq il- kultura u s- sensitività tal- mikro- organiżmi minn kawżi tal- mard f’ irziezet jew minn esperjenza riċenti fir- razett.
Do not use in animals suffering from severe liver or kidney disease, oliguria or anuria.
Tużax f’ annimali li qegħdin ibagħtu minn mard sever tal- fwied jew tal- kliewi, l- oligurja jew l- anurja.
Do not use in animals with impaired haematopoietic systems.
Tużax f’ annimali li għandhom il- ħsara fis- sistema hematopojetika.
4.4 Special warnings for each target species
4. 4 Twissijiet speċjali għal kull speċi li għaliha hu indikat il- prodott
In broilers water intake should be checked regularly.
Fil- brojlerijiet it- teħid tal- ilma għandi jiġi ċċekkjat regolarment.
Severely diseased animals can have a decreased appetite and water consumption.
Annimali li huma morda severament jistgħu jkolhom nuqqas fl- aptit u konsum fl- ilma.
If necessary the concentration of the VMP in the drinking water should be adjusted to make sure that the recommended dosage is being consumed.
Jekk hemm bżonn il- konċentramnt fil- VMP ta ’ l- ilma tax- xorb għandu jigi aġġustat sabiex jassigura li d- dosaġġ rakkomandat qiegħed jittieħed.
However if the concentration of the product is increased too much, the intake of the medicated drinking water decreases for palatability reasons.
Iżda jekk il- konċentrament tal- prodott tiżdied iżżejjed, it- teħid ta ’ l - ilma tax- xorb medikat jonqos għar- raġunijiet ta ’ togħma.
Therefore water intake should be monitored, especially in broilers.
Għalhekk it- teħid ta ’ l- ilma għandu jiġi moniterjat, speċjalment fil brojlerijiet.
12/ 19 4.5 Special precautions for use
13/ 20 4. 5 Prekawzjonijiet Speċjali għall- Użu
Special precautions for use in animals Due to the likely variability (time, geographical) in the occurrence of resistance of bacteria for trimethoprim/ sulfamethoxazole bacteriological sampling and susceptibility testing are recommended.
Prekawzjonijiet speċjali għall- użu fl- annimali Minħabba il- probabilità tal- varjabilità (il- ħin, il- ġeografija) fil- waqtiet tar- reżistenza tal- batterja għat - trimethoprim/ sulfamethoxazole kampjuni batterjoloġiku u ttestjat għas- suxxettibbiltà huma rakkomandati.
Special precautions to be taken by the person administering the veterinary medicinal product to animals During preparation and administration of the medicated drinking water, skin contact with the drug should be avoided.
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali Waqt il- preparament u l- amministrazzjoni tal- ilma tax- xorb medikat, il- kuntatt mal- ġilda bid- droga għandu jiġi evitat.
Therefore it is recommended to wear impermeable gloves e. g. rubber or latex when applying the product.
Għalhekk huwa rakkomandat li jintlibsu ingwanti li ma jgħaddix l- ilma minnhom eż tal- lastiku jew il- latex meta jiġi applikat il- prodott.
In case of allergy to trimethoprim or sulfonamides, special care should be taken when handling this product or the medicated solution.
F’ każ ta ’ allerġija għat- trimethoprim jew għas - sulfonamidi attenzjoni spejali għandha tingħata meta tkun qiegħed taħdem b’ dan il- prodott jew soluzjoni medikata.
In the event of eye contact, rinse the eye with copious amounts of clean water and if irritation occurs, seek medical attention.
F. każ ta ’ kuntatt ma ’ l- għajnejn, laħlaħ sew b’ ħafna ilma nadif u jekk ikun hemm irritazzjoni, fittex assistenza medika.
In the event of accidental ingestion, seek medical advice.
F’ każ illi tibla ’ biż- żball, fittex assistenza medika.
Wash hands and contaminated skin immediately after handling the product.
Aħsel l- idejn u l- ġilda kontaminata mill- ewwel wara li tmiss il- prodott.
4.6 Adverse reactions (frequency and seriousness)
4. 6 Effetti mhux mixtieqa (frekwenza u gravità)
A diminished water intake in chickens may occur occasionally.
Nuqqas ta ’ teħid ta ’ ilma f’ tiġieġ jista jiġri kultant.
Hypersensitivity reactions can occur rarely.
Reazzjonjiet ħipersensittivi jistgħu jiġru rarament.
4.7 Use during pregnancy, lactation or lay
4. 7 Użu fit- Tqala, fi żmien il- ħalib u meta jbidu l- bajd
The safety of the veterinary medicinal product has not been established during pregnancy, lactation or lay.
Is- sigurtà tal- prodott mediċinali veterinarju ma ġietx stabbilita waqt it- tqala, fi żmien il- ħalib, jew meta jbidu l- bajd.
4.8 Interaction with other medicinal products and other forms of interaction
4. 8 Effetti fuq prodotti mediċinali oħra jew effetti oħra
Do not combine with other veterinary medicinal products.
Tikkombinax ma ’ prodotti veterinarji mediċinali oħra.
4.9 Amounts to be administered and administration route
4. 9 Doża rakkomandata u l- metodu ta 'amministrazzjoni
Methoxasol-T is intended for oral administration with drinking water:
Il- Methoxasol- T huwa maħsub għall- amministrazzjoni orali ma ’ l- ilma tax- xorb:
25 mg/ kg bodyweight, corresponding to approximately 1 litre of the drug in 500 L drinking water, for 3-4 days.
25 mg/ kg toqol tal- ġisem, li jikkorrispondi għal bejn wieħed u ieħor 1 litru tad- droga f’ 500 L ta ’ ilma tax- xorb, għal 3- 4 ijiem.
33 mg/ kg bodyweight, corresponding to approximately 1 litre of the drug in 750 L drinking water, for 3-4 days.
33mg/ kg toqol tal- ġisem, li jikkorrispondi għal bejn wieħed u ieħor 1 litru tad- droga f’ 750 L ta ’ ilma tax- xorb, għal 3- 4 ijiem.
To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
Sabiex jiġi żgurat dosaġġ korrett it- toqol tal- ġisem għandu jiġi deċiż preċiż kemm jista ’ ikun sabiex jiġi evitat nuqqas ta ’ dosaġġ.
The uptake of medicated water depends on the clinical condition of the animals.
It- teħid ta ’ ilma medikat jiddipendi fuq il- kondizzjoni medika tal - annimali.
In order to obtain the correct dosage the concentration of Methoxasol-T has to be adjusted accordingly.
Sabiex takwista d- dosaġġ it- tajbal- konċentrament tal- Methoxasol- T għandu jiġi aġġustat skond il- bżonn.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti) jekk ikun hemm bżonn
A 2 ½ fold overdose is well tolerated by pigs.
Dosaġġ ta ’ darbtejn u nofs huwa aċċetat sew fil- ħnieżer.
In chicken an acute overdose will not occur because the birds will be reluctant to drink the strongly concentrated drinking water (too bitter taste if above 2 litres Methoxasol-T per 1000 litre drinking water).
Fit- tiġieġ dosaġġ akuta mhix ser tiġri peress li l- agħsafar ma jkunux iridu jixorbu l- ilma b’ konċentrament qawwija (togħma qarsa ħafna jekk iżjed minn 2 litri ta ’ Methoxasol- T kull 1000 liru ta ’ ilma tax- xorb).
Chronic overdose in chicken will result in a strongly diminished water- and feed intake and retarded growth.
Dosaġġ kroniku fit- tiġieg iwassal f’ nuqqas qawwi ta ’ tehid tal- ilma jew għalf u nuqqas ta ’ tkabbir.
4.11 Withdrawal period(s)
4. 11 Perjodu ta 'Tiżmim
5 days Broilers:
Il- brojlerijiet:
6 days
5 ijiem 6 ijiem
Not authorised for use in laying birds producing eggs for human consumption
Mhux awtorizzat li jintuża f' annimali li qed jaħilbu, u li l- ħalib tagħhom qed jintuża għall- konsum tan - nies.
13/ 19 5.
14/ 20 5.
Trimethoprim is a diaminopyrimidine, a synthetic folic acid antagonist.
It- Trimethoprim huwa dijaminopirimidin, aċidu antagonist foliku sintetiku.
Sulfamethoxazole is a broad- spectrum antimicrobial agent belonging to the sulfonamides.
Is- sulfamethoxazole huwa aġent antimikrobijal bis- spettru wiesa ’ li jagħmel parti mis- sulfonamides.
ATC vet classification (of the combination):
Il- klassifikazzjoni tal- ATC vet (tal- kombinazzjoni):
5.1 Pharmacodynamic properties
5. 1 Kwalitajiet Farmakodinamiċi
In vitro trimethoprim is generally bacteriostatic and has a broad spectrum of activity against both gram- positive and gram-negative bacteria.
In vitro t- trimethoprim huwa ġeneralment batteriostatiku u għansu spetru wiesa ’ ta ’ attività kontra kemm il- batterja tal- gram- posittiv kif ukoll tal- gram- negattiv.
A synergistic and bactericidal effect occurs when trimethoprim is combined with sulfamethoxazole, because trimethoprim and sulfamethoxazole inhibit sequential steps in the synthesis of tetrahydrofolic acid, an essential metabolic cofactor in bacterial synthesis of purine and, subsequently, DNA.
Effett sinerġistiku u batterocidiku jseħħ meta t- trimethoprim huwa kombinat mas- sulfamethoxazole, peress li t- trimethoprim u s - sulfamethoxazole jżommu lura passi wara xulxin fis- sinteżi tal- aċidu tetrahidrofoliku, kofattur essenzjali metaboliku fis- sintesi batterika tal- purine u, sussegwentament, id- DNA.
5.2 Pharmacokinetic particulars
5. 2 Tagħrif Farmakokinetiċi
Following oral administration both active ingredients are rapidly absorbed from the gut.
Wara l- amministrazzjoni orali iż- żewġ ingredjenti attivi huma assorbiti malajr mill- musrana.
The Cmax of sulfamethoxazole in pigs is approximately 6.2 µg/ g.
Is- Cmax tas- sulfamethoxazole fil- ħnieżer hija bejn wieħed u iehor 6. 2 µg/ g.
The Cmax of trimethoprim is 0.29 µg/ g.
Is- Cmax tat- trimethoprim hija 0. 29 µg/ g.
The Cmax of sulfamethoxazole in chickens is approximately 9.0 µg/ g, whereas that of trimethoprim is 0.12 µg/ g.
Is- Cmax tas- sulfamethoxazole fit- tiġieġ hija bejn wieħed u ieħor 9. 0 µg/ g, mentri dik tal - trimethoprim hija ta ’ 0. 12 µg/ g.
High trimethoprim concentrations are found in the kidneys, the liver and the lungs.
Konċentramenti għoljin ta ’ trimethoprim jinsabu fil- kliewi, fil- fwied u fil- pulmun.
With the exception of the kidneys, sulfamethoxazole concentrations in the tissues are significantly lower than in the plasma.
Bl- eċċezjoni tal - kliewi, il- konċentramenti tas- sulfamethoxazole fit- tessuti huma baxxi ħafna milli fil- plażma.
Protein binding for TMP and SMX is not very high.
L- urbit tal- proteina għat- TMP u s- SMX mhux daqstant għoli.
The drug is primarily excreted through the kidneys (both actively and passively), but elimination also occurs through the faeces.
Id- droga primarjament titneħħa mill- kliewi (kemm attivament kif ukoll passivament), iżda l - eliminazzjoni tiġri wkoll permezz tal- ħmieġ.
Elimination is relatively fast both in poultry and pigs.
L- eliminazzjoni hija kemm xejn għolja fit- tajr u l- ħnieżer.
Plasma elimination half-life for trimethoprim in poultry is less than 1 hour and that of sulfamethoxazole, approximately 1.5 hours.
L- eliminazzjoni tan- nofs ħajja tal- plażma għat- trimethoprim fit- tajr hija anqas minn siegħa u dik tas - sulfamethoxazole, bejn wieħed u ieħor siegħa u nofs.
In pigs, elimination half-life for both substances is approximately 2.5 hours.
Fil- ħnieżer, l- elimnazzjoni tan- nofs ħajja għaż - żewġ sustanzi hija bejn wieħed u ieħor sagħtejn u nofs.
Within 48 hours after the last medication trimethoprim, sulfamethoxazole and their metabolites are undetectable in urine and faeces.
F’ 48 siegħa wara l- aħħar medikazzjoni bit - trimethoprim, sulfamethoxazole u l- metaboliti tagħhom ma jdhrux fl- awrina u l- ħmieġ.
6.1 List of excipients
6. 1 Lista ta ’ ingredjenti
Propylene glycol, Sodium hydroxide, Water, purified, N-methyl-pyrrolidone
Propylene glycol Idrossidu tas- Sodju Ilma, purifikat N- methyl- pyrrolidone
Solubility and stability of Methoxasol-T in drinking water are pH-dependent.
Is- solubilità u s- stabilità tal- Methoxasol- T fl- ilma tax- xorb huma dipendenti fuq il- pH.
In the absence of compatibility 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.
6.3 Shelf life
6. 3 Żmien ta 'kemm il- prodott idum tajjeb
3 years After first opening the remaining shelf life is 12 months.
3 snin Żmien li l- prodott jibqa ’ tajjeb wara li jkun tneħħa mill- ewwel ippakkjar huwa ta ’ 12- il xahar.
Shelf-life after dilution or reconstitution according to directions:
Żmien li l- prodott jibqa 'tajjeb wara li jitħallat jew jiġi dilwit skond l- istruzzjonijiet fuq il- pakkett:
Special precautions for storage
15/ 20 6. 4 Tagħrif speċjali dwar kif għandu jinħażen
14/ 19 6.5 Nature and composition of immediate packaging
6. 5 In- natura u l- għamla ta ’ l- ewwel ippakkjar
HDPE bottle / can: volume 1000 ml / 5000 ml.
HDPE flixkun / bott: volum 1000 ml / 5000 ml.
The 1000 ml bottle is closed with a tamper-proof LDPE screw-cap.
Il- flixkun tal- 1000 ml huwa magħluq b’ tap bil- kamin LDPE mhux mbagħbas.
The 5000 ml can is closed with a tamper-proof HDPE screw-cap.
Il- bott tal- 5000 ml huwa magħluq b’ tap bil- kamin HDPE mhux mbagħbas.
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 użata 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 products should be disposed of in accordance with local requirements.
Saqsi lil veterinarju tiegħek dwar kif l- aħjar li tarmi l- mediċini li mA jkunux aktar meħtieġa minnek.
Handelsweg 25, P. O. Box 179, 5530 AD Bladel, The Netherlands
Handelswegg 25, PO Box 179, 5530 AD Bladel, The Netherlands
10 DATE OF REVISION OF THE TEXT
DATA TA ’ META ĠIET RIVEDUTA DIN IL- KITBA
PROHIBITION OF SALE, SUPPLY AND/ OR USE
PROJBIZZJONI TA ’ BEJGĦ, PROVISTA, U/ JEW UŻU
Not applicable.
Mhux Applikabbli.
15/ 19 IMMEDIATE PACKAGING
16/ 20 IPPAKKJAR PRIMARJU
16/ 19 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
17/ 20 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
Trimethoprim and sulfamethoxazole.
Methoxasol- T soluzjoni orali għall- ħnieżer u brojlerijiet Trimethoprim and sulfamethoxazole.
Oral solution.
Soluzjoni orali
TARGET SPECIES
SPEĊI GĦAL X' HIEX HUWA INDIKAT IL- PRODOTT
Pigs and broilers
Ħnieżer u brojlerijiet
Treatment and control of respiratory infections caused by Actinobacillus pleuropneumoniae susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the herd.
Trattament u prevenzjoni ta 'infezzjonijiet respiratorji kkawżati minn Actinobacillus pleuropneumoniae suxxettibbli għat- trimethoprim u s- sulfamethoxazole fejn il- marda instabet fil - merħla.
Treatment and control of respiratory infections caused by Escherichia coli susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the flock.
Trattament u prevenzjoni ta 'infezzjonijiet respiratorji kkawżati minn Escherichia coli suxxettibbli għat- trimethoprim u s- sulfamethoxazole fejn il- marda instabet fil- merħla.
17/ 19 7.
18/ 20 7.
METHOD AND ROUTE(S) OF ADMINISTRATION, POSOLOGY
METODU U MOD( I) TA 'AMMINISTRAZZJONI
Methoxasol is intended for oral administration with drinking water:
Il- Methoxasol- T huwa maħsub għall- amministrazzjoni orali ma ’ l- ilma tax- xorb:
In order to obtain the correct dosage the concentration of Methoxasol has to be adjusted accordingly.
Sabiex takwista d- dosaġġ it- tajbal- konċentrament tal- Methoxasol- T għandu jiġi aġġustat skond il- bżonn.
WITHDRAWAL PERIOD
ŻMIEN TA 'TIŻMIM
Special precautions for use in animals Due to the likely variability (time, geographical) in the occurrence of resistance of bacteria for trimethoprim / sulfamethoxazole bacteriological sampling and susceptibility testing are recommended.
Prekawzjonijiet speċjali għall- użu fl- annimali Minħabba il- probabilità tal- varjabilità (il- ħin, il- ġeografija) fil- waqtiet tar- reżistenza tal- batterja għat - trimethoprim/ sulfamethoxazole kampjuni batterjoloġiku u ttestjat għas- suxxettibbiltà huma rakkomandati.
Use during pregnancy and lactation The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Użu fit- Tqala u fi żmien il- ħalib Is- sigurtà tal- prodott mediċinali veterinarju ma ġietx stabbilita waqt it- tqala u fi żmien il- ħalib.
Interactions Do not combine with other veterinary medicinal products.
Effetti fuq prodotti mediċinali oħra Tikkombinax ma ’ prodotti veterinarji mediċinali oħra.
Overdose A 2 ½ fold overdose is well tolerated by pigs.
19/ 20 Doża eċċessiva Dosaġġ ta ’ darbtejn u nofs huwa aċċetat sew fil- ħnieżer.
18/ 19 In chicken an acute overdose will not occur because the birds will be reluctant to drink the strongly concentrated drinking water (too bitter taste if above 2 litres Methoxasol per 1000 litre drinking water).
Fit- tiġieġ dosaġġ akuta mhix ser tiġri peress li l- agħsafar ma jkunux iridu jixorbu l- ilma b’ konċentrament qawwija (togħma qarsa ħafna jekk iżjed minn 2 litri ta ’ Methoxasol- T kull 1000 liru ta ’ ilma tax- xorb).
Overdose in chicken will result in a strongly diminished water- and feed intake and retarded growth.
Dosaġġ kroniku fit- tiġieg iwassal f’ nuqqas qawwi ta ’ tehid tal- ilma jew għalf u nuqqas ta ’ tkabbir.
SPECIAL STORAGE CONDITIONS
KONDIZZJONIJIET SPEĊJALI DWAR KIF GĦANDU JINĦAŻEN
Keep out of the reach and sight of children.
Żomm ‘ il bogħod u fejn ma jidhirx mit- tfal.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA 'PRODOTTI MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jiġu mormija ma ’ l- ilma jew ma ’ l- iskart domestiku.
Ask your veterinary surgeon how to dispose of medicines no longer required.
Saqsi lil veterinarju tiegħek dwar kif l- aħjar li tarmi l- mediċini li ma jkunux aktar meħtieġa minnek.
These measures should help to protect the environment.
Dawn il- miżuri għandhom jgħinu sabiex jipproteġu l- ambjent.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OF 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.
Għal Trattament ta ’ l- Annimali Biss.
To be supplied only on veterinary prescription.
Għandu jingħata biss bi preskrizzjoni medika.
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 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
MARKETING AUTHORISATION NUMBER
NUMRU/ I TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
London, September 2008 EMEA/ 436209/ 2008
Londra, 26 ta 'Settembru 2008 EMEA/ 436209/ 2008
COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) OPINION FOLLOWING AN ARTICLE 35 REFERRAL FOR SODIUM SALICYLATE
KUMITAT GĦALL- PRODOTTI MEDIĊINALI GĦALL- UŻU VETERINARJU OPINJONI WARA RIFERIMENT GĦALL- ARTIKOLU 35 KIF EMENDAT GĦAL SALIĊILAT TAS- SODJU
On 27 November 2007, Ireland presented to the EMEA a referral under Article 35 of Directive 2001/ 82/ EC, as amended, concerning all oral soluble powders containing sodium salicylate which are indicated for calves and pigs.
Fis- 27 ta ’ Novembru, l- Irlanda ppreżentat lill- EMEA referenza skond l- Artikolu 35 tad- Direttiva 2001/ 82/ KE, kif emendat, dwar it- trabijiet orali kollha li jiddewbu li fihom is- saliċilat tas- sodju li huma indikati għall- għoġiela u l- ħnieżer.
Ireland considered that there was a potentially serious risk to animal health by providing for the authorisation of a potentially ineffective medicine for mass use by farmers, especially when there are several authorised NSAIDs available for individual animal use.
L- Irlanda kkunsidrat li kien hemm riskju potenzjalment serju għas- saħħa ta ’ l- annimali jekk tingħata l - awtorizzazzjoni għal mediċina potenzjalment ineffikaċi għall- użu tal- massa mill- bdiewa, speċjalment meta hemm diversi NSAIDs awtorizzati għall- użu individwali fuq l- annimali.
Ireland believed that the use of such a medicine for mass medication could mask the clinical signs of a developing infectious disease which could spread to other animals and thereby pose both an animal health and public health risk.
L- Irlanda qieset li l- użu ta ’ mediċina bħal din għall- medikazzjoni tal- massa tista ’ taħbi sinjali kliniċi ta ’ marda infettiva li tkun qiegħda tiżviluppa li tista ’ tinfirex għall- annimali oħrajn u b’ hekk tpoġġi f’ riskju kemm is- saħħa ta ’ l - annimal kif ukoll is- saħħa pubblika.
The referral procedure started on 11 December 2007 and after adoption of a list of questions, the clock was stopped on 15 January 2008.
Il- proċedura ta ’ referenza bdiet fil- 11 ta ’ Diċembru 2007 u wara l- adozzjoni ta ’ lista ta ’ mistoqsijiet, twaqqfet fil- 15 ta ’ Jannar 2008.
Further to the submission of responses to questions, the clock was re-started on 14 March 2008.
Sussegwentement għall- preżentazzjoni tat- tweġibiet għall- mistoqsijiet, il- proċedura reġgħet bdiet fl- 14 ta 'Marzu 2008.
The aim of the assessment was to establish whether marketing authorisations and applications included in the referral procedure should be granted, maintained, suspended, varied or revoked with view to the grounds for referral.
L- iskop tal- valutazzjoni kienet li tistabbilixxi jekk awtorizzazzjonijiet u applikazzjonijiet għat- tqegħid fis- suq inklużi fil- proċedura ta ’ referenza għandhomx jingħataw, jinżammu, jiġu sospiżi, varjati jew irrevokati mil- lat ta ’ raġunijiet għar- referenza.
As the procedure concerns a range of products, the assessment has been limited to specific parts of the authorisations in accordance with Article 35(2) of Directive 2001/ 82/ EC, as amended.
Peress li l- proċedura tikkonċerna firxa ta ’ prodotti, il - valutazzjoni ġiet limitata għall- partijiet speċifiċi ta ’ l- awtorizzazzjonijiet f’ konformità ma ’ l - Artikolu 35( 2) tad- Direttiva 2001/ 82/ KE, kif emendata.
The Marketing Authorisation Holders and Applicant submitted written responses and the clock was re- started on 14 March 2008.
Id- Detenturi ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Applikant ippreżentaw tweġibiet bil - miktub u l- proċedura reġgħet bdiet fl- 14 ta ’ Marzu 2008.
The clock was stopped again on 14 May 2008 and restarted on 6 June when responses to the outstanding issues where received.
Il- proċedura reġgħet twaqqfet fl- 14 ta ’ Mejju 2008 u reġgħet bdiet fis- 6 ta ’ Ġunju meta waslu tweġibiet għall- kwistjonijiet pendenti.
Oral explanations were provided on 15 July 2008 and the CVMP Opinion was adopted on 16 July 2008.
Ingħataw spjegazzjonijiet orali fil- 15 ta ’ Lulju 2008 u l- Opinjoni tas- CVMP kienet adottata fis- 16 ta ’ Lulju 2008.
Having considered the grounds for referral and the responses provided by the Marketing Authorisation Holder and Applicant the CVMP concludes that:
Wara li kkunsidra r- raġunijiet għar- referenza u t- tweġibiet ipprovduti mid- Detentur u l- Applikant ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq, is- CVMP ikkonkluda li:
• Therapeutic concentrations are established and maintained following oral use of sodium salicylate in calves and pigs.
• il- konċentrazzjonijiet terapewtiċi huma stabbiliti u miżmumin wara l- użu orali tas- saliċilat tas - sodju fl- għoġiela u l- ħnieżer.
The dosage required for calves is however 40 mg/ kg bodyweight.
Id- dożaġġ meħtieġ għall- għoġiela madankollu huwa 40 mg/ kg piż tal- ġisem.
• The efficacy of sodium salicylate as supportive treatment when given to calves and pigs was demonstrated in respiratory infections and the usefulness of this compound was clear for the treatment of inflammation in combination with concurrent antibiotic therapy.
• L- effikaċja tas- saliċilat tas- sodju bħala trattament ta ’ appoġġ meta mogħti lill- għoġiela u l- ħnieżer intweriet f’ infezzjonijiet respiratorji u l- utilità ta ’ din it- taħlita kienet ċara għat- trattament ta ’ infjammazzjoni f’ kombinazzjoni ma ’ terapija antibijotika fl- istess ħin.
Reproduction is authorised provided the source is acknowledged. • The benefit/ risk balance of the product was shown to be positive, however in young animals, the summary of Product Characteristics should state that the product is not to be used in neonates or very young calves of less than 2 weeks of age nor in piglets of less than 4 weeks of age.
Reproduction is authorised provided the source is acknowledged. • Il- bilanċ ta ’ riskju/ benefiċċju tal- prodott intwera li huwa pożittiv, madankollu f’ annimali ta 'età żgħira, is- Sommarju tal- Karatteristiċi tal- Prodott għandu jiddikjara li l- prodott la għandu jintuża fi frieħ li jkunu għadhom kif twieldu jew f’ għoġiela ta' età żgħar ħafna ta ’ età inqas minn ġimagħtejn u lanqas fi driefeġ iżgħar minn 4 ġimgħat.
The following indications have been justified:
L- indikazzjonijiet li ġejjin ġew iġġustifikati:
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
Pigs: to promote recovery of respiration and to reduce coughing in respiratory tract infections with concurrent antibiotic therapy.
Ħnieżer: biex jippromwovi l- irkuprar tar- respirazzjoni u jnaqqas is- sogħla f’ infezzjonijiet tal- passaġġi respiratorji ma ’ terapija fl- istess ħin bl- antibijotiċi.
NA-Salicylaat, 100%, powder for solution for oral administration
NA- Salicylaat, 100%, trab għal soluzzjoni orali
Calves: supportive treatment of pyrexia in acute respiratory disease, in combination with appropriate (e. g. anti-infective) therapy if necessary.
Għoġiela: trattament ta ’ appoġġ għal deni f’ mard respiratorju akut, f’ kombinazzjoni ma ’ terapija (eż.: antinfettiva) adegwata jekk meħtieġa.
For the treatment of inflammation in combination with concurrent antibiotic therapy.
Għat- trattament ta ’ infjammazzjoni f’ kombinazzjoni ma ’ terapija antibijotika mogħtija fl - istess ħin.
SOLACYL 100%, powder for oral solution for calves and pigs
SOLACYL 100%, trab għal soluzzjoni orali għall- għoġiela u l- ħnieżer
Calves: supportive treatment of pyrexia in acute respiratory disease, in combination with appropriate (e. g. anti-infective) therapy if necessary.
Għoġiela: trattament ta ’ appoġġ għal deni f’ mard respiratorju akut, f’ kombinazzjoni ma ’ terapija (ngħidu aħna anti- infettiva) addattata jekk meħtieġa.
The CVMP Opinion was adopted on 16 July 2008 and the subsequent Commission Decision adopted on 26 September 2008.
L- opinjoni tas- CVMP ġiet adottata fis- 16 ta ’ Lulju 2008 u d- Deċiżjoni sussegwenti tal- Kummissjoni ġiet adottata fis- 26 ta ’ Settembru 2008.
EMEA/ 436209/ 2008 Page 2/ 2
EMEA/ 436209/ 2008- MT Page 2/ 2
NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER / APPLICANT
ISEM, GĦAMLA FARMAĊEWTIKA, QAWWA TAL- PRODOTT MEDIĊINALI, SPEĊI TA ’ L- ANNIMALI, MNEJN JINGĦATA, U D- DETENTUR/ APPLIKANT TA ’ L - AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
1/ 9 Member State / Marketing Authorisation Number
1/ 9 Stat Membru / Numru ta ’ l - Awtorizzazzjoni għall- Kummerċ
Marketing Authorisation Holder
Detentur ta ’ l - Awtorizzazzjoni għall - Kummerċ
Product invented name
Isem ivvintat tal - prodott
Strength / Active substance (INN)
Qawwa / Sustanza attiva (INN)
Austria (8-00694)
L- Awstrija (8- 00694)
Sodium salicylate
Saliċilat tas- sodju (Sodium salicylate)
Pigs
Ħnieżer
The Netherlands (REG NL 8913)
L- Olanda (REG NL 8913)
NA-SALICYLAAT, 100%, powder for solution for oral administration
NA- SALICYLAAT, 100%, trab għal soluzzjoni orali
Sodium salicylate
Saliċilat tas- sodju
Calves and Pigs
Għoġiela u ħnieżer
The Netherlands (REG NL 10411)
L- Olanda (REG NL 10411)
Decentralised procedure subject to an Article 33 Referral (CD 17 April 2008)
Proċedura deċentralizzata soġġetta għal Riferiment skond l- Artikolu 33 (CD 17 ta ’ April 2008)
SOLACYL 100%, powder for oral solution for calves and pigs
SOLACYL 100%, trab għal soluzzjoni orali għall- għoġiela u l - ħnieżer
2/ 9 ANNEX II
2/ 9 ANNESS II
3/ 9 SCIENTIFIC CONCLUSIONS
3/ 9 KONKLUŻJONIET XJENTIFIĊI
Further to the submission of responses to questions, the clock was re-started on 14 March 2008.
Sussegwentement għall- preżentazzjoni tat- tweġibiet għall - mistoqsijiet, il- proċedura reġgħet bdiet fl- 14 ta 'Marzu 2008.
2.1 Questions put to the Marketing Authorisation Holder
2. 1 Mistoqsijiet imressqin lid- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq
The MAHs are requested to provide from the dossier submitted for each country of the EEA where the products are authorised: a) the Part I Summary of the dossier including SPCs, expert reports and the full composition of the products; b) if applicable, Part IV of the application dossier; c) an Assessment of the Periodic Safety Update Reports (PSURs) in relation to target animal safety and possible lack of efficacy.
Il- MAHs huma mitlubin li jipprovdu mid- dossier sottomess għal kull pajjiz taż- ŻEE fejn il - prodotti huma awtorizzati: a) is- Sommarju ta ’ Parti I tad- dossier inkluż l- SPC, rapporti ta ’ l- esperti u l- kompożizzjoni sħiħa tal- prodotti; b) il- Parti IV tad- dossier ta ’ l- applikazzjoni, jekk applikabbli; c) Valutazzjoni tar- Rapporti Perjodiċi ta ’ Aġġornament tas- Sigurtà (PSURs) fir- rigward tas - sigurtà ta ’ l- annimali fil- mira u n- nuqqas fl- effikaċja possibbli.
Pivotal documents, including the SPC, should be presented in English.
Dokumenti bażi, inkluż l- SPC, għandhom jiġu ppreżentati bl- Ingliż.
It is known that sodium salicylate when administered by the intravenous route to calves prior to castration failed to attenuate the cortisol response1.
Huwa magħruf li meta s- saliċilat tas- sodju jingħata minn ġol- vina lill- għoġiela qabel il - kastrazzjoni, dan ma jirnexxielux inaqqas ir- reazzjoni tal- kortiżol1.
Given this outcome together with published data on the pharmacokinetics of sodium salicylate in calves and significant variation in individual pig concentrations post treatment2, the MAHs should justify that therapeutic concentrations are established and maintained following oral use of the drug through water medication and submit all available data that could substantiate the posology and dosage regimen of sodium salicylate when given orally to calves and pigs, together with a thorough discussion of the these data.
B’ dan ir- riżultat flimkien ma ’ dejta ppubblikata fuq il- farmakokinetika tas- saliċilat tas- sodju fl- għoġiela u l- varjazzjoni sinifikanti f’ konċentrazzjonijiet individwali wara t- trattament2 fil- ħnieżer, il- MAHs għandhom jiġġustifikaw li l- konċentrazzjonijiet terapewtiċi huma stabbiliti u miżmumin wara l- użu orali tal- mediċina permezz ta ’ medikazzjoni bl- ilma u għandhom jippreżentaw id- dejta disponibbli
4/ 9 3.
4/ 9 li tista ’ tappoġġa l- pożoloġija u r- reġim tad- doża tas- saliċilat tas- sodju meta mogħti oralment lill- għoġiela u l- ħnieżer, flimkien ma ’ diskussjoni bir- reqqa ta ’ din id- dejta.
The MAHs should submit all existing data that could demonstrate the efficacy of sodium salicylate when given to calves and pigs, together with a thorough discussion of the these data.
Il- MAHs għandhom jissottomettu d- dejta kollha eżistenti li tista ’ turi l- effikaċja ta ’ sodium salicylate meta mogħti lill- għoġiela u l- ħnieżer, flimkien ma ’ diskussjoni bir- reqqa ta ’ din id - dejta.
The MAHs should discuss the benefit/ risk balance of the product, with special regard to: • the merits of using sodium salicylate as an oral medication for mass administration in cattle and pigs when individual treatment with parenteral NSAIDs may offer more precise therapy; • the use for analgesic and antipyretic effects under field condition, bearing in mind that the use in young animals which are suffering disease stress may lead to a potentiation of the undesirable effects of salicylate toxicity.
Il- MAHs għandhom jiddiskutu l- bilanċ bejn ir- riskju u l- benefiċċju tal- prodott, b’ rigward speċjali għal: • il- meriti ta ’ l- użu tas- saliċilat tas- sodju bħala medikazzjoni orali għall- għoti lill- massa fil - bhejjem ta 'l- ifrat u l- ħnieżer meta trattament individwali b’ NSAIDs parenterali jista ’ joffri terapija iktar preċiża; • l- użu għall- effetti analġeżiċi u antipiretiċi f’ kundizzjonijiet prattiċi, filwaqt li għandhom iżommu f’ moħħhom li l- użu f’ annimali żgħar li jkunu qegħdin isofru minn stress tal- mard jista ’ jwassal għal żieda fil- qawwa ta ’ l- effetti mhux mixtieqa ta ’ tossiċità mis- saliċilati.
2.2 Documentation provided
2. 2 Dokumentazzjoni pprovduta
Chevita Ges m. b. H. submitted all requested parts of the dossier (Part I and Part IV) as well as a dose determination study, which was not included in Part IV of the application dossier.
Chevita Ges m. b. H. ippreżentat il- partijiet tad- dossier mitlubin kollha (Parti I u Parti IV) kif ukoll studju tal- kalkolu tad- doża, li ma kienx inkluż fil- Parti IV tad- dossier ta ’ l- applikazzjoni.
NA-Salicylaat, 100%, powder for solution for oral administration and NA-Salicylaat, 80% WSP
NA- Salicylaat, 100%, trab għal soluzzjoni orali u NA- Salicylaat, 80% WSP
Dopharma submitted all requested parts of the dossier (Part I, Part IV and PSURs).
Dopharma ppreżentat il- partijiet tad- dossier mitlubin kollha (Parti I, Parti IV u PSURs).
Dopharma also described the history of the product since 1987, the year of its first authorisation in the Netherlands.
Dopharma ddeskriviet ukoll l- istorja tal- prodott mill- 1987, is- sena ta ’ l- ewwel awtorizzazzjoni tiegħu fl- Olanda.
Solacyl 100%, powder for oral solution for calves and pigs
Solacyl 100%, trab għal soluzzjoni orali għall- għoġiela u l- ħnieżer
Eurovet referred to the originator product from Dopharma, Na-salicylaat 100%, REG NL 8913.
Eurovet irreferiet għall- prodott oriġinatur minn Dopharma, Na- salicylaat 100%, REG NL 8913.
As a generic product only part I and not part IV of the dossier was submitted.
Minħabba li huwa prodott ġeneriku ġiet ppreżentata biss parti I u mhux parti IV tad- dossier.
No PSURs were submitted as the product is not yet marketed.
L- ebda PSURs ma kienu ppreżentati peress li l- prodott s’ issa għadu ma tpoġġiex fis- suq.
Solacyl was the subject of an Article 33 Referral, further to the submission of a Decentralised Application.
Solacyl kien is- suġġett ta ’ referenza skond l- Artikolu 33, wara l- preżentazzjoni ta ’ Applikazzjoni Deċentralizzata.
The CVMP concluded that Solacyl 100% powder for oral solution was essentially similar to the reference product, Natrium salicylaat 100%.
Is- CVMP ikkonkluda li Solacyl 100% trab għall- soluzzjoni orali kien essenzjalment simili għall- prodott ta ’ referenza, Natrium salicylaat 100%.
Consequently, the same conclusions on efficacy and safety apply to both products.
Konsegwentement, l- istess konklużjonijiet dwar l- effikaċja u s- sigurtà japplikaw għaż- żewġ prodotti.
It was 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.
Kien irrakkomandat li Solacyl 100% trab għal soluzzjoni għall- għoġiela u l- ħnieżer għandu jsegwi r- riżultat tar- referenza tal- Komunità skond l - Artikolu 35( 2) għat- trabijiet orali li jiddewbu li fihom is- saliċilat.
The Commission Decision on the Article 33 referral was adopted on 17 April 2008.
Id- Deċiżjoni tal- Kummissjoni dwar ir- referenza ta ’ l- Artikolu 33 ġiet adottata fis- 17 ta ’ April 2008.
• The benefit/ risk balance of the product was shown to be positive, however in young animals, the summary of Product Characteristics should state that the product is not to be used in neonates or very young calves of less than 2 weeks of age nor in piglets of less than 4 weeks of age
5/ 9 • Il- bilanċ ta ’ riskju/ benefiċċju tal- prodott intwera li huwa pożittiv, madankollu f’ annimali ta 'età żgħira, is- Sommarju tal- Karatteristiċi tal- Prodott għandu jiddikjara li l- prodott la għandu jintuża fi frieħ li jkunu għadhom kif twieldu jew f’ għoġiela ta' età żgħar ħafna ta ’ età inqas minn ġimagħtejn u lanqas fi driefeġ iżgħar minn 4 ġimgħat.
5/ 9 The following indications have been justified:
L- indikazzjonijiet li ġejjin ġew iġġustifikati:
6/ 9 ANNEX III
6/ 9 ANNESS III
AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS
EMENDI TAS- SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
7/ 9 Amendments to be included in the relevant sections of the SPC:
7/ 9 Emendi biex jiġu inklużi fis- sezzjonijiet relevanti ta 'l- SPC:
Do not use in piglets of less than 4 weeks of age.
Tużax fi driefeġ ta 'età inqas minn 4 ġimgħat.
Do not use sodium salicylates in neonates or calves less than 2 weeks of age.
Tużax is- saliċilati tas- sodju fi frieħ li jkunu għadhom kif twieldu jew f’ għoġiela iżgħar minn ġimagħtejn.
4.9 Amounts to be administered and administration route
4. 9 Doża rakkomandata u l- metodu ta 'kif jingħata
In calves, the dose administered should be amended to read 40 mg/ kg once daily.
Fl- għoġiela, id- doża mogħtija għandha tiġi emendata sabiex taqra 40 mg/ kg darba kuljum.
4.2 Indications for use, specifying the target species
4. 2 Indikazzjonijiet għal użu tal- prodott li jispeċifikaw l- ispeċi li fuqhom se jintuża l- prodott
SOLACYL 100%, powder for oral solution for calves and pigs
8/ 9 SOLACYL 100%, trab għal soluzzjoni orali għall- għoġiela u l- ħnieżer
8/ 9 4.3 Contraindications
4. 3 Kontraindikazzjonijiet
London, May 2008 EMEA/ 209536/ 2008
Londra, Mejju 2008 EMEA/ 209536/ 2008
COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL AS AMENDED FOR SOLACYL
KUMITAT GĦALL- PRODOTTI MEDIĊINALI GĦALL- UŻU VETERINARJU OPINJONI WARA RIFERIMENT GĦALL- ARTIKOLU 33( 4) KIF EMENDAT GĦAL SOLACYL
Solacyl 100% powder for oral solution for calves and pigs is indicated in calves for supportive treatment for reduction of pyrexia in acute respiratory disease, in combination with appropriate (e. g. anti-infective) therapy if necessary and in pigs for the supportive treatment for relief of pain in musculoskeletal disorders in combination with appropriate (e. g. anti-infective) therapy if necessary.
Solacyl 100% trab f’ soluzzjoni orali għall- għoġġiela u ħnieżer huwa indikat f’ għoġġiela għal trattament ta ’ sostenn għat- tnaqqis ta ’ pireksja f’ mard respiratorju akut, flimkien ma ’ terapija xierqa (e. ż. anti- infettiva) jekk meħtieġa u fi ħnieżer għal trattament ta ’ sostenn għat- taffija ta ’ uġiegħ f’ mard muskoloskeletali flimkien ma ’ terapija (e. ż. anti- infettiva) jekk meħtieġa.
In August 2006 a Decentralised Procedure started with The Netherlands as Reference Member State and thirteen Concerned Member States.
F’ Awwissu 2006 bdiet Proċedura Deċentralizzata fl- Olanda f’ forma ta ’ Stati Membri ta ’ Referenza u tlettax – il Stat Membru Konċernat.
Ireland considered that, due to the absence of efficacy documentation it could not be assumed that the product is efficacious and that this as such presents a potential serious risk to animal health.
L- Irlanda kkunsidrat illi, minħabba n- nuqqas ta ’ dokumentazzjoni effikaċi ma jistax jiġi assunt illi l - prodott huwa effikaċi u li dan hekk kif inhu jippreżenta risku serju u potenzjali għas- saħħa ta ’ l - annimal.
The Netherlands notified the EMEA in November 2007 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMD(v)) failed to reach an agreement for Solacyl 100% powder for oral solution and the matter was referred to the CVMP.
L- Olanda innotifikat lill- EMEA f’ Novembru 2007 li l- Grupp ta ’ Koordinazzjoni għar - Rikonoxximent Reċiproku u Proċeduri Deċentralizzati – Veterinajri (CMD( v)) sfaxxaw u ma laħqux ftehim dwar Solacyl 100% trab għal soluzzjoni orali u l- affari ġiet referuta quddiem is- CVMP.
Solacyl 100% powder for oral solution is a generic of Natrium salicylaat (authorised in The Netherlands).
Solacly 100% trab għal soluzzjoni orali huwa ġeneriku ta ’ Natrium salicylaat (awtorizzat fl- Olanda).
CVMP started the referral procedure on 11 December 2007 and agreed on a 37 day time frame.
Is- CVMP beda l- proċedura fil- 11 ta ’ Diċembru 2007 u qabel fuq perjodu ta ’ 37 jum.
A List of Questions was adopted by CVMP and sent to the applicant on 12 December 2007.
Is- CVMP adotta Lista ta ’ Mistoqsijiet u din intbagħtet lill- applikant fit- 12 ta ’ Diċembru 2007.
The applicant submitted written responses to the List of Questions on 10 January 2008 and the clock was re-started.
L- applikant issottometta tweġibiet bil- miktub għal- Lista ta ’ Mistoqsijiet fl- 10 ta ’ Jannar 2008 ż- żmien reġa ’ nbeda.
On the basis of the grounds for referral, CVMP considered any differences between Solacyl 100% powder and the reference product that could justify different conclusions on the efficacy for the two products.
Minħabba r- raġunijiet għar- riferiment, is- CVMP ikkunsidra kull differenza bejn it- trab tas- Solacyl 100% u l- prodott ta ’ referenza li tista ’ tiġġustifika l- konklużjonijiet differenti fuq l- effikaċja 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.
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.
The CVMP Opinion was adopted on 13 February 2008 and the subsequent Commission Decision adopted on 17 April 2008.
L- opinjoni tas- CVMP ġiet adottata fit- 13 ta ’ Frar 2008 u d- Deċiżjoni sussegwenti tal- Kummissjoni ġiet adottata fis- 17 ta ’ April 2008.
EMEA/ 209536/ 2008
EMEA/ 209536/ 2008- MT
1/ 7 Applicant or Marketing Authorisation Holder
1/ 7 L- Applikant jew id - Detentur ta ’ l - Awtorizzazzjoni għat- Tqegħid fis - Suq
Animal Frequency and species route of administration
Speċi ta ’ annimal
Solacyl 100% powder for oral solution
Solacyl 100% trab għal soluzzjoni orali
powder
trab
Calves oral and pigs
Għoġġiela orali
Calves:
Għoġġiela:
20 mg sodium salicylate per kg bodyweight twice daily, for 1 to 3 days.
20 mg sodium salicylate għal kull kg piż korporali darbtejn kuljum, għal 1 sa 3 ijiem.
Administration: orally in drinking water or milk(replacer).
Amministrazzjoni: oralment fl- ilma tax - xorb jew ħalib( sostitut).
Pigs:
Majjali:
35 mg sodium salicylate per kg bodyweight per day, for 3 to 5 days.
35 mg sodium salicylate għal kull kg piż korporali, għal bejn 3 u 5 ijiem.
Administration: orally in drinking water.
Amministrazzjoni: oralment fl- ilma tax - xorb.
Alternatively Solacyl can also be administered with the drinking water as pulse medication.
Inkella Solacyl jista ’ jingħata wkoll ma ’ l - ilma tax- xorb bħala mediċina għal perjodu qasir.
Half of the calculated total daily amount of powder is mixed with 5-10 litres of clean water and stirred until evenly dispersed.
Nofs l- ammont totali ta ’ kuljum ikkalkulat ta ’ trab jitħallat ma ’ bejn 5 u 10 litri ilma nadif u jitħawwad sakemm jitferrex b’ mod uniformi.
This solution is then added, whilst stirring, into an amount of drinking water that will be consumed within approximately 3-4 hours and administered twice daily.
Din is- soluzzjoni mbagħad tiżdied, waqt it- taħwid, ma ’ ammont ta ’ ilma tax- xorb li jkun se jinxtorob fi żmien 3- 4 sigħat u tingħata darbtejn kuljum.
The Netherlands, reference member state in the decentralised procedure, notified the EMEA on 26 November 2007 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMD(v)) failed to reach an agreement for Solacyl 100% powder for oral solution.
L- Olanda, Stat Membru ta ’ referenza fil- proċedura ta ’ deċentralizzazzjoni, fis- 26 ta ’ Novembru 2007, għarraf lill- EMEA li l- Grupp ta ’ Koordinazzjoni għall- Għarfien Reċiproku u l- Proċeduri Deċentralizzati - Veterinarji (is- CMD( v)) naqas milli jilħaq ftehim dwar it- trab ta ’ Solacyl 100% għas - soluzzjoni orali.
Pursuant to Article 33(4) of Council Directive 2001/ 82/ EC, as amended, the matter was referred to the CVMP.
Skond l- Artikolu 33( 4) tad- Direttiva tal- Kunsill 2001/ 82/ KE, kif emendata, il- materja ġiet referita lis- CVMP.
Ireland considers that, due to the absence of efficacy documentation it cannot be assumed that the product is efficacious and that this as such presents a potential serious risk to animal health.
L- Irlanda tqis li, minħabba n- nuqqas ta ’ dokumentazzjoni dwar l- effikaċja wieħed ma jistax jassumi li l- prodott huwa effikaċi u li dan jippreħenta riskju serju potenzjali għas- saħħa ta ’ l- annimali.
CVMP noted that Solacyl 100% powder for oral solution is a generic of Natrium salicylaat (authorised in The Netherlands) and that the concerns raised by Ireland could only be addressed in the framework of this procedure, in case any differences between both products would justify different conclusions on the safety or efficacy.
Is- CVMP innota li t- trab ta ’ Solacyl 100% għas- soluzzjoni orali huwa ġeneriku ta ’ Natrium salicylaat (awtorizzat fl- Olanda) u li t- tħassib imqajjem mill- Irlanda jista ’ jiġi indirizzat biss fil- qafas ta ’ din il - proċedura, fil- każ li jkun hemm xi differenzi bejn iż- żewġ prodotti li tkun tista ’ tiġġustifika l - konklużjonjiet differenti għas- sigurtà u l- effikaċja.
On the basis of the grounds for referral CVMP considered any differences between Solacyl 100% powder and the reference product that could justify different conclusions on the efficacy for the two products.
Minħabba r- raġunijiet għar- riferiment, is- CVMP ikkunsidra kull differenza bejn it- trab tas- Solacyl 100% u l- prodott ta ’ referenza li tista ’ tiġġustifika l- konklużjonijiet differenti fuq l- effikaċja għaż - żewġ prodotti.
The application dossier and any data added to it up to Day 60 of the referral procedure in CMD(v) to be provided to all CVMP Members and the EMEA.
Id- dossier ta ’ l- applikazzjoni u kull dejta miżjuda magħha sas- 60 Jum tal- proċedura tar- riferiment fis- CMD( v) jiġi pprovdut lill- Membri kollha tas- CVMP u lill- EMEA.