qanastek/EMEA-V3 huggingface dataset:
Thus, the risk of transmission of zoonotic pathogens to humans is considered rather low.
Għalhekk, ir- riskju tat- trażmissjoni ta 'patoġeni żoonotiċi għall- bniedem huwa kkunsidrat pjuttost baxx.
It is noted that there are no reports (PSURs) on lack of efficacy or developing resistance following use of TMP/ SDZ in horses.
Ġie nnutat li ma hemmx rapporti (PSUR) dwar in- nuqqas ta 'effikaċja jew l - iżvilupp ta' reżistenza wara l- użu ta 'TMP/ SDZ fiż- żwiemel.
Regarding the recommended dose, PK/ PD-analysis is of limited value, considering that:
Dwar id- doża rakkomandata, l- analiżi tal- proprjetajiet farmakoċinetiċi/ farmakodinamiċi hi ta 'valur limitat, meta wieħed iqis li:
- recent data on susceptibility and resistance of equine target pathogens are missing;
- id- dejta riċenti fuq is- suxxettibilità u r- reżistenza tal- patoġeni taż- żwiemel fil- mira hi nieqsa;
- pharmacokinetic data do not allow proper comparison of the plasma concentration profiles in the
- id- dejta farmakoċinetika ma tippermettix tqabbil xieraq tal- profili tal- konċentrazzjoni tal- plażma
horse over the dosing intervals and the entire treatment period depending on a once or twice daily dosing regimen.
fiż- żwiemel matul l- intervalli tad- dożi u l- perjodu sħiħ tat- trattament li jiddependi minn dożi ta 'l - amministrazzjoni darba jew darbtejn kuljum.
At most, it indicates that a daily dose of 2 X 30 mg/ kg may be necessary when pathogens involved in the disease are less susceptible to TMP/ SDZ.
L- iktar l- iktar tindika li jista 'jkun hemm bżonn doża ta' kuljum ta '2 X 30 mg/ kg meta l- patoġeni involuti jkunu inqas suxxetibbli għal TMP/ SDZ.
However, the data are not enough to clearly differentiate between the susceptibility of pathogens since no breakpoints are established for potentiated sulphonamides in equine infections.
Madankollu, id- dejta mhix biżżejjed biex turi b' mod ċar id- differenza bejn is- suxxettibilità tal- patoġeni billi ma ġewx stabbiliti l- punti kruċjali għas - sulfonamidi fl- infezzjonijiet fiż- żwiemel.
Moreover, there are no clinical studies in pathogens others than Salmonella employing a daily dose of 2 X 30 mg/ kg body weight.
Madankollu, ma hemmx studji kliniċi dwar il- patoġeni ħlief is- Salmonella li jirrikjedu doża ta '2 X 30 mg/ kg tal- piż tal- ġisem kuljum.
Therefore, it is not possible to recommend explicitly diseases or bacterial species for which the higher (2 X 30 mg/ kg bw) or the lower dose (1 X 30 mg/ kg bw) is appropriate.
Għalhekk mhux possibbli li jiġu rakkomandati b' mod espliċitu mardiet u speċi batteriċi li għalihom ikunu xierqa d- doża l- għolja (2 X 30 mg/ kg tal- piż tal- ġisem) u d- doża l- baxxa (1 X 30 mg/ kg tal- piż tal- ġisem).
It is noted that a daily dose of 2 X 15 mg/ kg bw is recommended in several SPCs.
Huwa nnotat li doża ta 'kuljum ta' 2 X 15 mg/ kg tal- piż tal- ġisem hi rrakkomandata f' ħafna SPCs.
Taking into account the results of the clinical studies, pharmacokinetic properties of TMP/ SDZ and practical aspects of twice daily dosing, once daily dosing of 30mg/ kg bw should be recommended.
Meta wieħed iqis ir- riżultati ta 'l- istudji kliniċi, il- karatteristiċi farmakoċinetiċi ta' TMP/ SDZ u l - aspetti prattiċi ta 'dożi ta' darbtejn kuljum, għandha tiġi rakkomandata doża ta '30 mg/ kg tal- piż tal - ġisem darba kuljum.
The clinical studies presented for the treatment of salmonellosis, applying a daily dose of 2 X 30 mg/ kg bw to be administered over 10 days are exceedingly poor (few animals, poor results).
L- istudji kliniċi ppreżentati għat- trattament tas- salmonellożi, b' applikazzjoni ta 'doża ta' 2 X 30 mg/ kg tal- piż tal- ġisem amministrata matul għaxart ijiem huma batuti ħafna (ftit annimali, riżultati insuffiċjenti).
The indication salmonellosis has therefore not been substantiated.
Għalhekk l- indikazzjoni għas- salmonellożi ma ġietx sostanzjata.
Some products include the recommendation to base treatment on susceptibility testing.
Huwa rrakkomandat li tiġi implimentata s- sentenza standard "L- użu tal- prodott għandu
It is recommended to implement the standard sentence “ Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies ” in section 4.5 of the SPC for all products.
15/ 18 jkun ibbażat fuq l- ittestjar għas- suxxettibilità u jikkunsidra l- politiki antimikrobiċi lokali u uffiċjali "fit- taqsima 4. 5 ta 'l- SPC għall- prodotti kollha.
13/ 16 In conclusion, considering the reasons and recommendations mentioned above, the dose of 1 X 30 mg/ kg bw per day to be administered over a maximum period of 5 days has been substantiated.
Finalment, meta wieħed iqis ir- raġunijiet u r- rakkomandazzjonijiet imsemmija hawn fuq, ġiet sostanzjata d- doża ta '1 X 30 mg/ kg tal- piż tal- ġisem kuljum amministrata matul perjodu massimu ta' ħamest ijiem.
2.5 Justification of the withdrawal period
2. 5 Ġustifikazzjoni tal- perjodu tat- tneħħija
Considering the grounds for referral, assessment of the withdrawal period is only consequential to an increment of the recommended dose.
Meta wieħed iqis ir- raġunijiet għar- riferiment, il- valutazzjoni tal- perjodu tat- tneħħija huwa biss konsegwenzjali għal żieda fid- doża rrakkomandata.
Since no increase to the dose is recommended, no change to the withdrawal period is required.
Billi ma kienx hemm żieda fid- doża rrakkomandata, ma hemmx bżonn ta 'tibdil fil- perjodu ta' tneħħija.
Having considered the grounds for referral and the responses provided by the Marketing Authorisation Holder, the CVMP concludes that there is no documented evidence from the field of problems relating to lack of efficacy or any change in the resistance situation of the relevant target pathogens that would constitute a concern relating to animal or human health.
Wara li ġew ikkunsidrati r- raġunijiet għar- riferiment u t- tweġibiet ipprovduti mid- Detentur ta 'l - Awtorizzazzjoni għat- Tqegħid fis- Suq, is- CVMP ikkonkluda li ma hemmx provi dokumentati mil- lat ta' problemi relatati man- nuqqas ta 'effikaċja jew ta' tibdil fis- sitwazzjoni ta 'reżistenza għall- patoġeni rilevanti li kienu jikkostitwixxu tħassib relatat ma' l- effikaċja jew ma 'tibdil fis- sitwazzjoni ta' reżistenza għall- patoġeni rilevanti li jwasslu għal tħassib relatat mas- saħħa ta 'l- annimali jew tal - bnedmin.
Therefore, the CVMP recommends maintaining the dose of 1 X 30 mg/ kg body weight per day to be administered over a maximum period of 5 days.
Għalhekk, is- CVMP jirrakkomanda ż- żamma tad- doża ta '1 X 30 mg/ kg tal- piż tal- ġisem amministrata matul perjodu ta' ħamest ijiem.
A twice daily dosing of 15 mg/ kg body weight is not recommended and should be deleted.
Doża ta '15 mg/ kg tal- piż tal- ġisem darbtejn kuljum mhijiex rakkomandata u għandha titħassar.
Indication salmonellosis has not been substantiated.
L- indikazzjoni tas- salmonellożi ma ġietx sostanzjata.
It is therefore recommended to delete this indication.
Għalhekk huwa rakkomandat li din l - indikazzjoni titħassar.
It is recommended to implement the standard sentence “ Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies ” in section 4.5 of the relevant SPCs.
Huwa rakkomandat li tiġi implimentata s- sentenza standard "L- użu tal- prodott għandu jkun ibbażat fuq l- ittestjar tas- suxxettibilità u jikkunsidra l- politiki antimikrobiċi lokali u uffiċjali" fit- taqsima 4. 5 ta 'l- SPCs.
Since no increase to the dose is recommended, no change to the withdrawal period is anticipated.
Billi ma hija rakkomandata ebda żieda fid- doża, ma huwa antiċipat l- ebda tibdil fil- perjodu ta 'tneħħija.
14/ 16 ANNEX III
16/ 18 ANNESS III
AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS
EMENDI GĦAS- SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
15/ 16 Amendments to be included in the relevant sections of the SPC:
17/ 18 Emendi li għandhom jiġu inklużi fis- sezzjonijiet rilevanti ta 'l- SPC:
Indications for use, specifying the target species
Indikazzjonijiet għall- użu, li jispeċifikaw l- ispeċi fil- mira
Delete, where applicable, salmonellosis from the indications.
Ħassar, fejn applikabbli, is- salmonellożi mill- indikazzjonijiet.
Special precautions for use
Prekawzjonijiet speċjali għall- użu
Include the following standard sentence:
Daħħal din is- sentenza standard:
“ 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 l- ittestjar għas- suxxettibilità u jikkunsidra politiki antimikrobiċi uffiċjali u lokali".
Amounts to be administered and administration route
Pożoloġija u metodu ta 'kif għandu jingħata
Delete, where applicable, the dose of 2 X 15 mg/ kg body weight per day.
Ħassar, fejn applikabbli, id- doża ta '2 X 15 mg/ kg tal- piż tal- ġisem kuljum.
This document is a summary of the European Public Assessment Report.
Dan id- dokument huwa sommarju tar- Rapport Pubbliku Ewropew ta 'Valutazzjoni.
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
L- għan tiegħu huwa li jispjega kif il- valutazzjoni mwettqa mill- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) abbażi tad- dokumentazzjoni pprovduta, wasslet għar- rakkomandazzjonijiet dwar il- kundizzjonijiet tal- użu.
This document cannot replace a face-to-face discussion with your veterinarian.
Dan id- dokument ma jistax jissostitwixxi diskussjoni wiċċ imb wiċċ mal- veterinarju tiegħek.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Jekk tixtieq iktar informazzjoni dwar il- kundizzjoni medika jew it- trattament tal- annimal tiegħek, ikkuntattja lill- veterinarju tiegħek.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq iktar informazzjoni relatata mar- rakkomandazzjonijiet tas- CVMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Acticam?
X’ inhu Acticam?
Acticam contains meloxicam which belongs to a class of medicines having anti-inflammatory action.
Acticam fih meloxicam li jappartjeni għal klassi ta ’ mediċini li jaġixxu kontra l - infjammazzjoni.
Acticam is presented as an oral suspension 1.5 mg/ ml for dogs (to be given mixed with food) and a solution for injection 5mg/ ml.
Acticam jiġi bħala sospensjoni orali ta ’ 1. 5 mg/ ml għall- klieb (li għandu jingħata mħallat mal- ikel) u soluzzjoni ta ’ 5 mg/ ml għall- injezzjoni.
Acticam is a ‘ generic’: this means that Acticam is similar to a ‘ reference veterinary medicine ’ already authorised in the EU (Metacam 1.5 mg/ ml oral suspension).
Acticam huwa ‘ ġeneriku ’: dan ifisser li Acticam huwa simili għal ‘ mediċina veterinarja ta ’ referenza ’ li hija diġà awtorizzata fl- UE (Metacam 1. 5 mg/ ml ta ’ sospensjoni orali).
Studies have been carried out to prove that Acticam is ‘ bioequivalent ’ to the reference veterinary medicine: this means that Acticam is equivalent to Metacam 1.5 mg/ ml suspension in the way it is absorbed and used by the body.
Twettqu studji sabiex juru li Acticam huwa ‘ bijoekwivalenti ’ għall- mediċina veterinarja ta ’ referenza: dan ifisser li Acticam huwa ekwivalenti għal Metacam 1. 5 mg/ ml ta ’ sospensjoni fil- mod ta ’ kif jiġi assorbit u użat mill- ġisem.
What is Acticam used for?
Għal xiex jintuża Acticam?
Dogs:
Klieb:
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders and reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.
Is- serħan mill- infjammazzjoni u uġigħ f’ mard muskolu- skeletriku kemm akut kif ukoll kroniku u t- tnaqqis ta ’ uġigħ u infjammazzjoni wara operazzjoni ortopedika u tat- tessut artab.
Cats:
Qtates:
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.
Tnaqqis tal- uġigħ ta ’ wara operazzjoni fejn jitneħħew l- ovarji u l- utru u operazzjoni minuri tat- tessut artab.
How does Acticam work?
Kif jaħdem Acticam?
Acticam contains meloxicam, which belongs to a class of medicines called non-steroidal anti- inflammatory drugs (NSAIDs).
Acticam fih meloxicam, li jappartjeni għall- klassi ta 'mediċini msejħin mediċini antinfjammatorji mhux sterojdali (NSAIDs).
Meloxicam acts by inhibition of prostaglandin synthesis.
Meloxicam jaġixxi billi jinibixxi s- sintesi tal - prostaglandini.
As the prostaglandins are substances that trigger inflammation, pain, exudation and fever, meloxicam reduces those responses.
Minħabba li l- prostaglandini huma sustanzi li jikkawżaw l- infjammazzjoni, l - uġigħ, il- ħruġ ta 'għaraq u d- deni, meloxicam inaqqas dawn ir- reazzjonijiet.
How has Acticam been studied?
Kif ġie studjat Acticam?
Acticam has been investigated in comparison with Metacam which is already authorised in the EU.
Acticam ġie eżaminat billi tqabbel ma ’ Metacam li huwa diġà awtorizzat fl- UE.
A study looked at how Acticam was absorbed and its effects in the body, in comparison with Metacam oral suspension 1.5mg/ ml.
Sar studju li ħares lejn kif Acticam ġie assorbit u l- effetti tiegħu fil- ġisem, meta mqabbla ma ’ 1. 5mg/ ml ta ’ sospensjoni orali Metacam.
What benefit has Acticam shown during the studies?
Liema benefiċċju wera Acticam waqt l- istudji mwettqa?
Acticam is efficacious in alleviating the inflammation and pain in both acute and chronic musculo-skeletal disorders and reducing the post operative pain following orthopaedic and soft tissue surgery in dogs and in reducing the post-operative pain after ovariohysterectomy and minor soft tissue surgery in cats.
Acticam huwa effikaċi fis- serħan tal- infjammazzjoni u uġigħ f’ mard muskoluskeletriku kemm akut kif ukoll kroniku u biex inaqqas l- uġigħ wara operazzjoni ortopedika u tat- tessut artab fil - klieb u fit- tnaqqis tal- uġigħ ta ’ wara operazzjoni fejn jitneħħew l- ovarji u l- utru u ta ’ wara operazzjoni minuri tat- tessut artab fil- qtates.
What is the risk associated with Acticam?
X’ inhu r- riskju assoċjat ma ’ Acticam?
Occasional side effects of Acticam are those seen with NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools and apathy (lack of vitality).
Effetti sekondarji mhux regolari ta ’ Acticam huma dawk li jidhru bl- NSAIDs, bħat- telf ta ’ aptit, rimetter, dijarrea, demm fil- feċi u apatija (nuqqas ta ’ vitalità).
These side effects occur usually within the first week of treatment and are generally temporary.
Dawn l- effetti sekondarji jidhru normalment matul l- ewwel ġimgħa tat- trattament u huma ġeneralment temporanji.
They disappear once treatment has stopped.
Huma jitilqu ladarba jitwaqqaf it- trattament.
In very rare cases, they may be serious or fatal.
F’ każijiet verament rari, jistgħu jkunu serji jew fatali.
Acticam should not be administered to pregnant or lactating animals as the safety of the product has not been established in these cases.
Acticam mgħandux jingħata lil annimali tqal jew li qed ireddgħu minħabba li s- sigurtà tal - prodotti ma ġiex stabbilit f’ dawn il- każijiet.
Acticam should also not be used in animals suffering from gastrointestinal or hemorrhagic disorders and impaired renal or hepatic function, animals with known hypersensitivity to NSAIDs, and animals less than 6 weeks of age or in cats of less than 2 kg.
Barra minn hekk Acticam mgħandux jintuża f’ annimali li jsofru minn mard gastrointestinali jew mard emorraġiku, jew annimali li għandhom indeboliment fil- funzjoni tal- kliewi jew tal- fwied, dawk li jkunu ipersensittivi għal NSAIDS u annimali ta ’ età inqas minn 6 ġimgħat jew qtates li jiżnu inqas minn 2 kg.
An oral follow-up therapy using meloxicam or other NSAIDs should not be used in cats, as no safe dosage for repeated oral administration has been established.
Terapija orali ta ’ segwitu bl- użu ta ’ meloxicam jew NSAIDs oħrajn mgħandux jingħata fil - qtates, minħabba li l- ebda dożaġġ sikur għadu ma ġie stabbilit għall- amministrazzjoni orali ripetuta.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
X' inhuma l- prekawzjonijiet li għandha tieħu persuna li tagħti l- mediċina jew li tiġi f' kuntatt mal- annimal?
People with known hypersensitivity (allergic) to meloxicam should avoid contact with the product.
Persuni li huma ipersensittivi (allerġiċi) għal meloxicam għandhom jevitaw kuntatt mal - prodott.
Accidental self-injection may give rise to pain.
Jekk wieħed jinjetta lilu nnifsu b’ mod aċċidentali dan jista ’ jwassal għall- uġigħ.
If the product is swallowed by a person, the advice of a doctor should be sought immediately.
Jekk il- prodott jinbela ’ minn persuna ghandu jitfittex parir mediku minnufih.
In case of accidental self-injection, medical advice should be sought immediately showing the package leaflet or the label to the physician.
Fil- każ li persuna tinjetta lilha nnifisha b’ mod aċċidentali, wieħed għandu jfittex parir mediku minnufih u għandu juri l- Fuljett ta ’ Tagħrif jew it- tikketta lit- tabib.
Why has Acticam been approved?
Għaliex ġie approvat Acticam?
The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Acticam has been shown to be bioequivalent to Metacam 1.5 mg/ ml oral suspension.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkunsidra li, skont ir - rekwiżiti tal- Unjoni Ewropea, Acticam kien jidher bħala bijoekwivalenti għal Metacam 1. 5 mg/ ml ta ’ sospensjoni orali.
The CVMP concluded that the benefits of Acticam exceed the risks for the alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders, reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery in dogs and reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery in cats and recommended that Acticam be given a marketing authorisation.
Is- CVMP ikkonkluda li l- benefiċċji ta ’ Acticam huma akbar mir- riskji tiegħu fit- taffija ta ’ infjammazzjoni u uġigħ f’ mard muskuloskeletriku tat- tip akut kif ukoll kroniku, fit- tnaqqis ta ’ uġigħ u infjammazzjoni ta ’ wara operazzjoni wara kirurġija ortopedika u tat- tessut artab fil- klieb u fit- tnaqqis ta ’ uġigħ ta ’ wara operazzjoni wara kirurġija fejn jitneħħew l- ovarji u l- utru u kirurġija minuri tat- tessut artab fil- qtates u rrakkomanda li Acticam jingħata awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ bejn il- benefiċċji u r- riskji jista 'jiġi kkonsultat fil- modulu 6 ta' dan l- EPAR.
Other information about Acticam:
Informazzjoni oħra dwar Acticam:
The European Commission granted a marketing authorisation valid throughout the European Union, for Acticam to Omnipharm Ltd on 9 December 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea għal Acticam lil Omnipharm Ltd fid- 9 ta ’ Diċembru 2008.
Information on the prescription status of this product may be found on the label/ outer package.
L- informazzjoni dwar l - istat tal- preskrizzjoni ta ’ dan il- prodott tista ’ tiġi kkonsultata fuq it- tikketta jew fuq il- qoxra tal- pakkett.
This summary was last updated in December 2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
Page 2/ 2  EMEA 2008
Paġna 2/ 2 ©EMEA 2008
EMEA Number
Numru ta ’ l- UE
Pharmaceutical Target species Form
Għamla Farmaċewtika
Route of administration
Speċi li fuqhom Kif għandu jintuża jingħata lprodott
Package size
Daqs talpakkett
Withdrawal Period
Perjodu ta ’ Tiżmim
oral suspension
Suspensjoni Orali
dogs oral
Orali
Polyethylene bottle
Flixkun talpoli - Etilin
N/ A
Mhux applikabbli.
solution for injection
Soluzzjoni
Dogs and cats
Klieb u
sc/ iv
Injezzjoni taħt ilġilda
Glass vial
Kunjett ta ’ linjezzjoni
N/ A
Mhux
Acticam 1.5 mg/ ml oral suspension for dogs
Acticam 1. 5 mg/ ml Suspensjoni orali għall- klieb
Each ml of Acticam 1.5 mg/ ml oral suspension contains:
Kull ml ta ’ Acticam 1. 5 mg/ ml suspensjoni orali fih:
Active substance(s):
Sustanza attiva:
(equivalent to 0.05 mg per drop)
Meloxicam 1. 5 mg (ekwivalenti għal 0. 05 mg kull qatra)
Excipients:
Sustanza( i) mhux attiva( i):
Sodium benzoate
Sodium benzoate 1. 5 mg (ekwivalenti għal 0. 05 mg kull qatra)
For a full list of excipients, see Section 6.1.
Għal- lista sħiħa ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Oral suspension Acticam is a pale green, uniform suspension containing 1.5 mg/ ml meloxicam
Suspensjoni orali.
4 CLINICAL PARTICULARS:
TAGĦRIF KLINIKU
4.1 Target species
4. 1 Speċi li għalihom huwa indikat il- prodott
Dogs
Klieb
4.2 Indications for use
4. 2 Indikazzjonijiet għall- użu tal- prodott li jispeċifikaw l- ispeċi li fuqhom se jintuża l- prodott
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Għas- serħan mill- infjammazzjoni u uġigħ f’ mard muskolu- skeletriku li jkun kemm akut kif ukoll kroniku.
Do not use in pregnant or lactating animals.
Tużax fuq annimali tqal jew li qed ireddgħu.
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Tużax fuq annimali li jsofru minn mard gastrointestinali, bħal irritazzjoni jew emorraġija, jew annimali li għandhom indeboliment fil- funzjoni tal- fwied, tal- qalb jew tal- kliewi, u mard emorraġiku.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Tużax f’ każ ta ’ sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
Do not use in dogs less than 6 weeks of age.
Tużax fuq klieb li għandhom inqas minn 6 ġimgħat.
4.4 Special warnings
4. 4 Twissijiet speċjali għal kull speċi li għaliha hu indikat il- prodott
Special precautions for use
4. 5 Prekawzjonijiet speċjali għall- użu
If side effects occur, treatment should be discontinued and the advice of the veterinarian should be sought.
Prekawzjonijiet speċjali għall- użu fl- annimali Jekk ikun hemm reazzjonijiet mhux mixtieqa, it- trattament għandu jitwaqqaf u għandu jittieħed il - parir ta ’ veterinarju.
2/ 34 Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
2/ 30 Evita l- użu fi kwalunkwe annimal li jkun deidratat, ipovolaemiku jew ipotensiv, għax hemm riskju potenzjali ta ’ tossiċità tal- kliewi.
This product for dogs should not be used in cats as it is not suitable for use in this species.
Dan il- prodott għall- klieb m’ għandux jintuża għall- qtates għax mhuwiex adattat għall- użu f’ din l - ispeċi.
Special precautions to be taken by the person administering the veterinary medicinal product product to animals
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali Persuni li jafu li għandhom sensittività eċċessiva għal NSAIDs għandhom jevitaw li jmissu mal - prodott mediċinali veterinarju.
In case of accidental ingestion, seek medical advice immediately and show the package insert or the label to the physician.
F’ każ li tibla ’ l- prodott b’ mod aċċidentali, fittex parir mediku minnufih u uri l- fuljett tal- pakkett jew it- tikketta lit- tabib.
Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood and apathy have occasionally been reported.
Reazzjonijiet avversi tipiċi tal- mediċini NSAIDs bħal nuqqas t’ aptit, rimettar, dijarea, demm moħbi fl - ippurgar, apatija u insuffiċjenza renali kienu rrappurtati xi kultant.
These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
Dawn l- effetti sekondarji ġeneralment iseħħu fi żmien l- ewwel ġimgħa tat- trattament, u f’ ħafna każijiet jgħaddu malajr u jisparixxu wara t- tmiem tat- trattament, iżda f’ każijiet rari ħafna, jistgħu jkunu serji jew fatali.
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 and lactation (see 4.3).
Is- sigurtà tal- prodott mediċinali veterinarju ma ġietx stabbilita waqt it- tqala u fi żmien il- ħalib (Ara 4. 3).
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects.
NSAIDs oħrajn, dijuretiċi, antikoagulanti, antibijotiċi aminoglycoside u sustanzi oħra li jeħlu ħafna mal- proteini, jistgħu jikkompetu għat- twaħħil u b’ hekk iwasslu għal effetti tossiċi.
Acticam must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Acticam m’ għandux jingħata flimkien ma ’ NSAIDs oħrajn jew ma ’ glukokortikosterojdi.
Pre- treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before commencement of treatment.
It- trattament minn qabel b’ sustanzi anti- infjammatorji jista ’ jirriżulta f’ effetti avversi addizzjonali jew miżjuda, u għalhekk għandu jiġi osservat perjodu ta ’ 24 siegħa mingħajr trattament b’ mediċini bħal dawn, qabel ma jibda t- trattament.
The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Il- perjodu mingħajr trattament, madankollu, irid jikkunsidra l - karatteristiċi farmakoloġiċi tal- prodotti użati qabel.
4.9 Amounts to be administered and administration route
4. 9 Doża rakkomandata u l- metodu ta ’ amministrazzjoni
Initial treatment is a single dose of 0.2 mg meloxicam/ kg body weight on the first day.
It- trattament tal- bidu jikkonsisti minn doża waħda ta ’ 0. 2 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem fl - ewwel jum.
Treatment is to be continued once daily by oral administration (24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/ kg body weight.
It- trattament għandu jitkompla darba kuljum bl- għoti orali (f’ intervalli ta ’ 24 siegħa) bid - doża tal- manteniment ta ’ 0. 1 mg meloxicam / kg ta ’ piż tal- ġisem.
The suspension can be given using either the drop dispenser (for very small breeds) or the Acticam measuring syringe provided in the package.
Għal trattament iktar fit- tul, ġaladarba r- rispons kliniku jkun ġie osservat (wara ≥ 4 ijiem), id- doża ta ’ Acticam tista ’ tiġi aġġustata għall- inqas doża effettiva individwali, li tirrifletti li l- grad ta ’ uġigħ u ta ’ infjammazzjoni marbuta ma ’ mard kroniku muskolu- skeletriku, jista ’ jvarja matul iż- żmien.
The syringe fits onto the bottle and has a kg-body weight scale which corresponds to the maintenance dose (ie.
Għandha tingħata attenzjoni partikulari fir- rigward ta ’ l- eżattezza tad- dożaġġ.
0.1 mg meloxicam/ kg body weight).
Ħawwad sew qabel l- użu.
Thus for the first day, twice the maintenance volume will be required.
Biex jingħata mill- ħalq jew imħallat ma ’ l- ikel jew direttamemt fil- ħalq.
Shake well before use.
Doża tal- bidu:
A clinical response is normally seen within 3- 4 days.
4 qtar / kg ta ’ piż tal- ġisem Doża tal- manteniment:
Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.
Rispons kliniku ġeneralment ikun osservat wara 3- 4 ijiem It- trattament għandu jitwaqqaf jekk wara perjodu massimu ta ’ 10 ijiem, l- ebda titjib kliniku ma jkun evidenti.
Avoid introduction of contamination during use.
Evita li tintroduċi xi kontaminazzjoni waqt l- użu.
3/ 34 4.10 Overdose (symptoms, emergency procedures, antidotes) (if necessary)
4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti), jekk ikun hemm bżonn
In the case of overdosage symptomatic treatment should be initiated.
F’ każ ta ’ doża eċċessiva, għandu jinbeda trattament sintomatiku.
4.11 Withdrawal periods
4. 11 Perjodu( i) ta ’ tiżmim
Not Applicable
Mhux applikabbli.
Non-steroidal, anti-inflammatory drug (NSAID)
Prodotti anti- infjammatorji u anti- rewmatiċi, mhux sterojdi (oxicams) Kodici ATĊ veterinarja:
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects.
Meloxicam hu mediċina anti- infjammatorja mhux sterojdika (NSAID) tal- klassi oxicam li taġixxi bl - inibizzjoni tas- sintesi ta ’ prostaglandin, u b’ hekk teżerċita effetti anti- infjammatorji, analġesiċi, kontra t- tnixxija u antipiretiċi.
It reduces leukocyte infiltration into the inflamed tissue.
Meloxicam inaqqas l- infiltrazzjoni tal- lewkoċiti fit- tessut infjammat.
To a minor extent it also inhibits collagen-induced thrombocyte aggregation.
Sa ċertu punt, Meloxicam jinibixxi l- aggregazzjoni tat- tromboċiti kkaġunata mill- kollaġen.
In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2(COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
Studji in vivo u in vitro urew li Meloxicam jinibixxi cyclooxygenase- 2 (COX- 2) b’ mod iktar qawwi minn cyclooxygenase- 1 (COX- 1).
When the product is used according to the recommended dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.
5. 2 Tagħrif farmakokinetiku
Distribution There is a linear relationship between the dose of meloxicam administered and plasma concentration observed in the therapeutic dose range.
Meta l- prodott jintuża skond il- kors rakkomandat tad - dożaġġ, il- konċentrazzjonijiet fl- istat fiss ta ’ meloxicam fil- plażma jintlaħqu fit- tieni jum tat - trattament.
Approximately 97% of meloxicam is bound to plasma proteins.
Madwar 97% ta ’ meloxicam jeħel mal- proteini tal- plażma.
The volume of distribution is 0.31/ kg.
Il- volum tad - distribuzzjoni hu ta ’ 0. 3 l/ kg.
Metabolism Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound.
Metaboliżmu Il- biċċa l- kbira ta ’ meloxicam jinsab fil- plażma u hu wkoll prodott ewlieni tat- tneħħija biljari, filwaqt li l- awrina fiha biss traċċi tal- kompost prinċipali.
Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites.
Meloxicam huwa metabolizzat għal alkoħol, derivattiv ta ’ l- aċidu u għal diversi metaboliti polari.
All major metabolites have been shown to be pharmacologically inactive.
Intwera li l- metaboliti prinċipali kollha huma farmakoloġikament inattivi.
Elimination Meloxicam is eliminated with a half-life of 24 hours.
Eliminazzjoni Meloxicam jiġi eliminat b’ half- life ta ’ 24 siegħa.
Approximately 75% of the administered dose of meloxicam is eliminated via faeces and the remainder via urine.
Madwar 75% tad- doża li tingħata titneħħa fl - ippurgar, u l- bqija fl- awrina.
6.
4/ 30 6.
Dispersible cellulose Xanthan gum Sodium benzoate Glycerol Xylitol
- Sodium benzoate
4/ 34 Sodium lauryl sulphate Citric acid monohydrate Sodium citrate Honey flavour Simethicone emulsion Purified water
- Sodium dihydrogen phosphate dihydrate
6.2 Incompatibilities
- Hydroxyethylcellulose
Not applicable.
- Honey aroma
6.3 Shelf-life
- Ilma, purifikat
2 years from date of manufacture on unopened bottle
6. 2 Inkompatibilitajiet
In-use shelf life:
Mhux applikabbli.
9 months
9 xhur
No special storage conditions.
Dan il- prodott mediċinali veterinarju m’ għandux bżonn ta ’ l- ebda kundizzjoni speċjali sabiex jinħażen.
Polyethylene bottle containing 10, 32 or 100 ml with a polyethylene dropper, a tamper proof child resistant closure and a polypropylene measuring syringe.
Flixkun tal- polyethylene li fih 10, 32 jew 100 ml b’ qattara tal- polyethylene, tapp li jirreżisti l- ftuħ mit - tfal żgħar u siringa tal- kejl tal- polypropylene.
6.6 Special precautions for the disposal of unused 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 products should be disposed of in accordance with local requirements.
Mediċina veterinarja li ma ġietx użata jew prodotti oħra li ntużaw għal din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
NAME OR CORPORATE NAME AND ADDRESS OR REGISTERED PLACE OF BUSINESS OF THE MARKETING AUTHORISATION HOLDER
L- ENTITÀ LI GĦANDHA L- AWTORIZZAZZJONI TAL- KUMMERĊ
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L- AWTORIZZAZZJONI TAL- KUMMERC
DATE OF FIRST AUTHORIZATION/ RENEWAL OF THE AUTHORIZATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIGDID TA ’ L- AWTORIZZAZZJONI
DATE OF REVISION OF THE TEXT
DATA TA ’ META GIET RIVEDUTA DIN IL- KITBA
PROHIBITION OF SALE, SUPPLY AND/ OR USE
PROJBIZZJONI TA ’ BEJGH, PROVVISTA, U/ JEW UZU
Acticam 5 mg/ ml solution for injection for dogs and cats.
Acticam 5 mg/ ml soluzzjoni għall- injezzjoni għall- klieb u l- qtates.
Each ml of Acticam 5 mg/ ml solution for injection contains:
Kull ml ta ’ Acticam 5 mg/ ml soluzzjoni għall- injezzjoni fih:
For a full list of excipients, see section 6.1.
Għal- lista sħiħa ta ’ l- ingredjenti mhux attivi, ara s- sezzjoni 6. 1.
4.1 Target species
4. 1 SPEĊI LI GĦALIHOM HUWA INDIKAT IL- PRODOTT
Dogs and cats.
Klieb u qtates
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Għas- solliev mill- infjammazzjoni u uġigħ f’ mard muskolu- skeletriku li jkun kemm akut kif ukoll kroniku.
Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.
Biex inaqqas l- uġigħ u l- infjammazzjoni wara operazzjoni ortopedika u tat- tessut artab.
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.
Tnaqqis ta ’ l- uġigħ ta ’ wara operazzjoni ta ’ l- ovarjo- isterektomija u ta ’ wara operazzjoni minuri tat - tessut artab.
Do not use in animals less than 6 weeks of age nor in cats of less than 2 kg.
Tużax f’ annimali li għandhom inqas minn 6 ġimgħat u lanqas fi qtates li jiżnu inqas minn 2 kg.
For post-operative pain relief in cats, safety has only been documented after thiopental/ halothane anaesthesia.
Biex itaffi l- uġigħ ta ’ wara l- operazzjoni fil- qtates, is- sigurtà kienet dokumentata biss wara loppju b’ thiopental/ halothane.
7/ 34 4.5 Special precautions for use
7/ 30 4. 5 Prekawzjonijiet speċjali għall- użu
If side effects occur, treatment should be discontinued.
Prekawzjonijiet speċjali għall- użu fl- annimali Jekk ikun hemm reazzjonijiet mhux mixtieqa, it- trattament għandu jitwaqqaf u għandu jittieħed il - parir ta ’ veterinarju.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Evita l- użu fi kwalunkwe annimal li jkun deidratat, ipovolaemiku jew ipotensiv, għax hemm riskju potenzjali ta ’ tossiċità tal- kliewi.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Kwalunkwe follow- up orali li bl- użu ta ’ meloxicam jew NSAIDs oħrajn m’ għandhomx jingħataw lill - qtates, minħabba li korsijiet adattati tad- dożaġġ għal dawn il- kuri follow- up ma kinux stabbiliti.
Accidental self-injection may give rise to pain.
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali Injezzjoni aċċidentali tiegħek nnifsek tista ’ tikkaġuna wġigħ.
People with known hypersensitivity to meloxicam should avoid contact with the veterinary medicinal product.
Persuni li jafu li għandhom sensittività eċċessiva għal NSAIDs għandhom jevitaw li jmissu mal- prodott mediċinali veterinarju.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
F’ każ li tinjetta b’ mod aċċidentali lilek innifsek, fittex parir mediku minnufih u uri l- fuljett tal- pakkett jew it- tikketta lit- tabib.
4..6 Adverse reactions (frequency and seriousness)
4. 6 Effetti mhux mixtieqa (frekwenza u gravità)
In dogs, these side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
Fil- klieb, dawn l- effetti sekondarji ġeneralment iseħħu fi żmien l- ewwel ġimgħa tat- trattament, u f’ ħafna każijiet jgħaddu malajr u jisparixxu wara t- tmiem tat- trattament, iżda f’ każijiet rari ħafna, jistgħu jkunu serji jew fatali.
Concurrent administration of potential nephrotoxic drugs should be avoided.
L- għoti flimkien ta ’ mediċini nefrotossiċi qawwija għandu jiġi evitat.
In animals at anaesthetic risk (e. g. aged animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration.
F’ annimali li jkunu f’ riskju tal- loppju (eż. annimali xjuħ), it- terapija bil- fluwidu ġol- vina jew taħt il- ġilda waqt il- loppju għandha tigi kkunsidrata.
When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.
Meta l - loppju u NSAID jingħataw flimkien, ma jistax jiġi eskluż li jista ’ jkun hemm riskju għall- funzjoni tal - kliewi.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before commencement of treatment.
It- trattament minn qabel b’ sustanzi anti- infjammatorji jista ’ jirriżulta f’ effetti avversi addizzjonali jew miżjuda, u għalhekk għandu jiġi osservat perjodu ta ’ 24 siegħa mingħajr trattament b’ mediċini bħal dawn, qabel ma tibda t- trattament.
The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Il- perjodu mingħajr trattament, madankollu, irid jikkunsidra l - karatteristiċi farmakoloġiċi tal - prodotti użati qabel.
Musculo-skeletal disorders:
Mard muskolu- skeletriku:
Single subcutaneous injection at a dosage of 0.2 mg meloxicam/ kg body weight (i. e.
Injezzjoni waħda taħt il- ġilda b’ dożaġġ ta ’ 0. 2 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem (i. e.
0.4 ml/ 10 kg body weight).
0. 4 ml/ 10 kg ta ’ piż tal- ġisem).
Acticam 1.5 mg/ ml oral suspension may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/ kg body weight, 24 hours after administration of the injection.
Acticam 1. 5 mg/ ml suspensjoni orali għall- klieb jista ’ jintuża għat- tkomplija tat- trattament f’ dożaġġ ta ’ 0. 1 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem, 24 siegħa wara l- għoti ta ’ l- injezzjoni.
Reduction of post-operative pain (over a period of 24 hours):
8/ 30 Tnaqqis ta ’ l- uġigħ ta ’ wara l- operazzjoni (matul perjodu ta ’ 24 siegħa):
Single intravenous or subcutaneous injection at a dosage of 0.2 mg meloxicam/ kg body weight (i. e.
Injezzjoni waħda ġol- vina jew taħt il- ġilda b’ dożaġġ ta ’ 0. 2 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem (i. e.
0.4 ml/ 10 kg body weight) before surgery, for example at the time of induction of anaesthesia.
0. 4 ml/ 10 kilogrammi ta ’ piż tal- ġisem), qabel l- operazzjoni, pereżempju meta jkun qed jingħata l- loppju.
8/ 34 Cats:
Qtates:
Reduction of post-operative pain:
Tnaqqis ta ’ l- uġigħ ta ’ wara l- operazzjoni:
Single subcutaneous injection at a dosage of 0.3 mg meloxicam/ kg body weight (i. e.
Injezzjoni waħda taħt il- ġilda b’ dożaġġ ta ’ 0. 3 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem (i. e.
0.06 ml/ kg body weight) before surgery, for example at the time of induction of anaesthesia.
0. 06 ml / kg ta ’ piż tal- ġisem), qabel l- operazzjoni, pereżempju meta jkun qed jingħata l- loppju.
Particular care should be taken with regard to the accuracy of dosing.
Għandha tingħata attenzjoni partikulari fir- rigward ta ’ l- eżattezza tad- dożaġġ.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti), jekk ikun hemm bżonn
In the case of over dosage symptomatic treatment should be initiated.
F’ każ ta ’ doża eċċessiva, għandu jinbeda trattament sintomatiku.
4.11 Withdrawal period(s)
4. 11 Perjodu( i) ta ’ tiżmim
Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATCvet code:
Prodotti anti- infjammatorji u anti- rewmatiċi, mhux sterojdi (oxicams) Kodici ATĊ veterinarja:
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class, which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects.
Meloxicam hu mediċina anti- infjammatorja mhux sterojdika( NSAID) tal- klassi oxicam li taġixxi bl - inibizzjoni tas- sintesi ta ’ prostaglandin, u b’ hekk teżerċita effetti anti- infjammatorji, analġesiċi, kontra t- tnixxija u antipiretiċi.
In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
Studji in vivo u in vitro urew li Meloxicam jinibixxi cyclooxygenase- 2 (COX- 2) b’ mod iktar qawwi minn cyclooxygenase- 1 (COX- 1).
Absorption Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma concentrations of 0.73 µg/ ml in dogs and 1.1 µg/ ml in cats were reached approximately 2.5 hours and 1.5 hours post administration, respectively.
5. 2 Tagħrif farmakokinetiku
Distribution There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range in dogs.
Assorbiment Wara l- għoti taħt il- ġilda, meloxicam hu kompletament bijodisponibbli, u l- ogħla medja ta ’ konċentrazzjonijiet fil- plażma ta ’ 0. 73 µg/ ml, fil- klieb u 1. 1 µg/ ml fil- qtates intlaħqu wara madwar 2. 5 sigħat u 1. 5 sigħat wara l- għoti rispettivament.
More than 97% of meloxicam is bound to plasma proteins.
Iktar minn 97% ta ’ meloxicam jeħel mal- proteini tal- plażma.
The volume of distribution is 0.3 l/ kg in dogs and 0.09 l/ kg in cats.
Il- volum tad - distribuzzjoni hu ta ’ 0. 3 l/ kg fil- klieb u 0. 09 l/ kg fil- qtates.
Metabolism In dogs, meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound.
Metaboliżmu Fil- klieb, il- biċċa l- kbira ta ’ meloxicam jinsab fil- plażma u hu wkoll prodott ewlieni tat- tneħħija biljari, filwaqt li l- awrina fiha biss traċċi tal- kompost prinċipali.
Elimination Meloxicam is eliminated with a half-life of 24 hours in dogs and 15 hours in cats.
9/ 30 Eliminazzjoni Meloxicam jiġi eliminat b’ half- life ta ’ 24 siegħa fil- klieb u 15- il siegħa fil- qtates.
Approximately 75% of the administered dose is eliminated via faeces and the remainder via urine.
Madwar 75% tad - doża li tingħata titneħħa fl- ippurgar, u l- bqija fl- awrina.
6.2 Incompatibilities
- Sodium chloride
Not applicable.
- Sodium hydroxide
Shelf-life of the veterinary medicinal product as packaged for sale:
- Ilma għall- injezzjoni
Shelf-life after first opening the immediate packaging:
3 snin Żmien li l- prodott jibqa ’ tajjeb wara li jkun tneħħa mill- ewwel ippakkjar:
28 days.
28 jum
Do not store above 25°C.
Taħżinx f’ temperaturi ogħla minn 25°C.
Colourless type I glass injection vial of 10 ml, closed with a grey EPDM rubber stopper and sealed with a flip off aluminium violet seal.
Kunjett tal- ħġieġ għall- injezzjoni, ta ’ 10 ml, mingħajr kulur, magħluq b’ tapp tal- lastku u ssiġillat b’ għatu ta ’ l- aluminju.
8.
10/ 30 8.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIGDID TA ’ L- AWTORIZZAZZJONI
10/ 34 10 DATE OF REVISION OF THE TEXT
DATA TA ’ META GIET RIVEDUTA DIN IL- KITBA
11/ 34 ANNEX II
11/ 30 ANNESS II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IS- SID TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL- PROVVISTA JEW L- UŻU
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV
STATEMENT OF THE MRLs
DIKJARAZZJONI TA ’ L- MRLs
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL - KUMMERĊ FUQ IL- PROVVISTA JEW L- UŻU
To be supplied only on veterinary prescription.
Għandu jingħata biss bi preskrizzjoni veterinarja.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV
13/ 34 ANNEX III
13/ 30 ANNESS III
LABELLING AND PACKAGE LEAFLET
TIKKETTA U L- FULJETT TA ’ TAGĦRIF
15/ 34 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
15/ 30 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Acticam 1.5 mg/ ml oral suspension for dogs
Acticam 1. 5 mg/ ml suspensjoni orali għall- klieb Meloxicam
TARGET SPECIES
INDIKAZZJONI( JIET)
Dogs
Mard muskolu- skeletriku akut u kroniku.
INDICATION(S)
METODU U MOD( I) TA ’ AMMINISTRAZZJONI
Alleviation of inflammation and pain in both acute and chronic musculo- skeletal disorders.
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett.
METHOD AND ROUTE(S) OF ADMINISTRATION
TWISSIJA( IET) SPEĊJALI OĦRA, JEKK MEĦTIEĠ
Avoid introduction of contamination during use.
Tużax fuq annimali tqal jew li qed ireddgħu.
WITHDRAWAL PERIOD
DATA TA ’ SKADENZA
Not applicable.
EXP {xahar/ sena} Jekk tiftaħ uża fi żmien:
9.
9 xhur.
SPECIAL STORAGE CONDITIONS
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA ’ PRODOTTI MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
Do not use after the expiry date stated on the carton and the bottle.
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
IL- KLIEM "GĦAL TRATTAMENT TA ’ L- ANNIMALI BISS ” U KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVVISTA U L- UZU, jekk applikabbli
Dispose of in accordance with local requirments.
Għal trattament ta ’ l- annimali biss.
For animal treatment only.
Għandu jingħata biss bi preskrizzjoni veterinarja
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
NUMRI TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
17/ 34 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
17/ 30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA
PHARMACEUTICAL FORM
KONTENUT BĦALA PIŻ, VOLUM JEW NUMRU TA ’ DOŻI
PACKAGE SIZE
MOD( I) TA ’ AMMINISTRAZZJONI
32 ml
Użu orali.
TARGET SPECIES
NUMRU TAL- LOTT
Dogs
Lot {numru}
INDICATION(S)
DATA TA ’ SKADENZA
Alleviation of inflammation and pain in both acute and chronic musculo- skeletal disorders.
9 xhur La darba jinfetaħ uża fi żmien...
Avoid introduction of contamination during use.
IL- KLIEM "GĦAL TRATTAMENT TA ’ L- ANNIMALI BISS ”
Read the package insert before use
Għal trattament ta ’ l- annimali biss.
EXPIRY DATE
18/ 30 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Acticam 1.5 mg/ ml oral suspension for dogs
Acticam 5 mg/ ml soluzzjoni għall- injezzjoni għall- klieb u l- qtates Meloxicam
Oral suspension
Soluzzjoni għall- injezzjoni
Dogs
Klieb u qtates
Not applicable.
28 jum.
SPECIAL WARNING(S), IF NECESSARY
KONDIZZJONIJIET SPEĊJALI DWAR KIF GĦANDU JINĦAŻEN
Do not use in pregnant or lactating animals.
Taħżinx f’ temperaturi ogħla minn 25°C.
9 months.
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA ’ PRODOTTI MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
For animal treatment only.
Għandu jingħata biss bi preskrizzjoni veterinarja.
21/ 34 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
20/ 30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
QUANTITY OF THE ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
KONTENUT SKOND IL- PIŻ, VOLUM JEW NUMRU TA ’ DOŻI
ROUTE(S) OF ADMINISTRATION
SPEĊJI LI GĦALIHOM HUWA INDIKAT IL- PRODOTT
Avoid introduction of contamination during use.
Klieb u qtates
WITHDRAWAL PERIOD
MOD( I) TA ’ AMMINISTRAZZJONI
Not applicable.
Klieb: jingħata ġol- vina jew taħt il- ġilda Qtates: jingħata taħt il- ġilda
< Batch > {number}
Lot {numru}
9 months.
EXP {xahar/ sena}