qanastek/EMEA-V3 huggingface dataset:
According to Article 71 of Directive 2001/ 82/ EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/ or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
Skond l- Artikolu 71 tad- Direttiva 2001/ 82/ KEE tal- Parlament Ewropew u tal- Kunsill, l- Istati Membri jipprojbixxu jew jistgħu jipprojbixxu l- importazzjoni, il- bejgħ, il- forniment u/ jew l- użu tal- prodott mediċinali veterinarju fit- territorju sħiħ tagħhom jew parti minnu jekk jiġi stabbilit illi:
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
a) l- għotja tal- prodott mediċinali veterinarju lill- annimali tinterferixxi ma ’ l- implimentazzjoni ta ’ programmi nazzjonali għad- djanjosi, il- kontroll u l- eradikazzjoni tal- mard ta ’ l- annimali, jew tikkawża diffikultajiet fiċ- ċertifikazzjoni ta ’ l- assenza tal- kontaminazzjoni f ’ annimali ħajjin jew fl- ikel jew prodotti oħrajn li jiġu minn annimali ttrattati;
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
b) il- marda li għaliha l- prodott mediċinali veterinarju huwa intiż li jagħti immunità hija ġeneralment assenti mit- territorju.
The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Bluetongue.
L- użu ta ’ dan il- prodott mediċinali veterinarju huwa permess biss taħt il- kondizzjonijiet partikolari stabbiliti mill- leġislazzjoni tal- Kommunita ’ Ewropea dwar il- kontrol tal- Bluetongue.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Is- sid tal- awtorizzazzjoni tal- Kummerċ għandu javża lill- Kummissjoni Ewropea dwar il- pjanijiet għall- kummerċ ta ’ dan il- prodott mediċinali awtorizzat b’ din id- deċisjoni.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV
The following substances are included in Annex II of Council Regulation (EEC) No 2377/ 90 in accordance with the following table:
Is- segwenti sustanzi huma inklużi fl- Anness II tar- Regolament tal- Kunsill (KE) Nru 2377/ 90 skond it- tabella li jmiss:
Pharmacologically active substance(s)
Sustanza( i) farmakoloġikament
Other provisions
Dispożizzjonijiet
All All
Kollha
EC 2796/ 95 EC 1433/ 96
KE 1433/ 96
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
OBBLIGAZZJONIJIET SPEĊIFIĊI TA 'SID L- AWTORIZZAZZJONI TAL - KUMMERĊ
The Applicant is required to submit in 6 months following the authorisation of the product, an action plan together with timelines for all points that require resolution in order for the authorisation to revert to normal status.
L- applikant għandu jissottometti fi żmien sitt xhur wara l- awtorizzazzjoni tal- prodott, programm t’ azzjoni fiz- żmien speċifikat għall- punti kollha li jeħtiegu riżoluzzjoni sabiex l- awtorizzazzjoni tmur lura għall- istatus normali.
The above information will be evaluated and approved by the CVMP and will form part of the subsequent annual reassessment.
L- informazzjoni t’ hawn fuq tiġi studjata u approvata mill CVMP u tifforma parti mill- valutazzjoni sussegwenti ta ’ kull sena.
For the first and subsequent annual reassessments the Marketing Authorisation Holder should provide annually an updated risk assessment on the continuous use of the vaccine taking into account the continued need for the vaccine, its history of use over the previous twelve months and progress made in addressing the items that require resolution in order for the authorisation to revert to normal status.
Għall- ewwel valutazzjoni u għal dawk sussegwenti ta ’ kull sena sid l- awtorizzazzjoni tal - Kummerċ għandu jipprovdi kull sena stima aġġornata tar- riskju dwar l- użu kontinwu tal- vaċċin wara li tieħu in konsiderazzjoni l- fatt li tibqa il- ħtiega tal- vaċċin, l- andament tal- użu tal- prodott fit- tnax- il xahar ta ’ qabel u l- progress li sar biex jissolvew dawk l- affarijiet li jeħtiegu riżoluzzjoni sabiex l- awtorizzazzjoni tista ’ tmur lura għal status normali.
The Applicant is required to submit 6-monthly Periodic Update Safety reports starting once the MA has been approved and, in addition to the legal requirements applicable to reporting of suspected adverse reactions, the Applicant is required to specifically monitor and evaluate the following suspected adverse reactions in the PSURs: abortions, spontaneous death, effects on milk production, local reactions, pyrexia, lethargy and hypersensitivity reactions, including severe allergic reactions.
L- applikant għandu jissottometti rapporti perjodiċi ta ’ kull sitt xhur ta ’ aġġornament fuq is - sigurta ’ tal- prodott ladarba l- awtorizzazzjoni tal- kummerċ ġiet approvata, u barra mill- ħtiega legali li jiġu irrapportati xi suspetti ta ’ effetti mhux mixtieqa, l- applikant għandu jagħmel monitoraġġ speċifiku ta ’ dawn l- effetti mhux mixtieqa fir- Rapporti Perjodiċi: abort, mewt f’ daqqa, effetti fuq il- produzzjoni tal- ħalib, reazzjonijiet lokali, deni, telqa, effetti ta ’ ipersensitivita ’, inklużi allerġiji qawwija.
The frequency of submissions of PSUR reports will be assessed at the annual reassessment of the product.
Il- frekwenza li bihom għandhom jiġu sottomessi r- rapporti perjodiċi dwar is- sigurta ’ tigi kkalkulata waqt l- istħarriġ annwali tal- prodott.
10 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10 DETTALJI LI GĦANDHOM JIDHRU FUQ IL- PAKKETT TA 'BARRA
Box of 1 bottle of 10 ml Box of 1 bottle of 50 ml, Box of 10 bottles of 50 ml, Box of 1 bottle of 100 ml, Box of 10 bottles of 100 ml
Kaxxa ta ’ flixkun ta ’ 10 ml Kaxxa ta ’ flixkun ta ’ 50 ml Kaxxa ta ’ 10 fliexken ta ’ 50 ml Kaxxa ta ’ flixkun ta ’ 100 ml Kaxxa ta ’ 10 fliexken ta ’ 100 ml
BTVPUR AlSap 8 suspension for injection
BTVPUR AISap 8 suspensjoni għall- injezzjoni.
BTV8 antigen ≥ 7.1 CCID50* Aluminium hydroxide, Saponin, qs 1 dose (*) (*) see package leaflet
Kull doża ta ’ millilitru ta ’ vaċċin fiha antiġen BTV 8 > 7. 1 CCID50 * Aluminju hydroxide Saponin qs doża (*) (*) Ara l- fuljett ta ’ tagħrif
1 bottle of 10 doses (1 x 10 ml) 1 bottle of 50 doses (1 x 50 ml) 10 bottles of 50 doses (10 x 50 ml) 1 bottle of 100 doses (1 x 100 ml) 10 bottles of 100 doses (10 x 100 ml)
flixkun ta ’ 10 dożi (1 x 10 ml) flixkun ta ’ 50 doża (1 x 50 ml) 10 fliexken ta ’ 50 doża (10 x 50 ml) flixkun ta ’ 100 doża (1 x 100 ml) 10 fliexken ta ’ 100 doża (10 x 100 ml)
Sheepand cattle
Nagħaġ u bovini
Active immunisation of sheep and cattle to prevent, viraemia and clinical signs caused by the bluetongue virus serotype 8.
Immunizzazzjoni attiva ta ’ nagħaġ u bovini għall - prevenzjoni kontra viremja u sinjali kliniċi ikkawżati mill- virus tal- bluetongue serotip 8.
Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif li jinsab fil- pakkett qabel tuża ’.
Subcutaneous use Read the package leaflet before use.
Taħt il- ġilda Aqra l- fuljett ta ’ tagħrif li jinsab fil- pakkett qabel tuża ’.
Withdrawal period: zero days
Żmien ta 'Tiżmim: xejn
EXP {month/ year} Shelf life after first opening the immediate packaging: immediately after broaching
EXP {xahar / sena} Żmien li l- prodott jibqa ’ tajjeb wara li jkun infetaħ il- pakkett ewlieni ghall- ewwel darba: immedjatament wara li jinfetaħ
Protect from light.
Aħżen u ttrasporta ġo friġġ (2°C – 8°C) Tagħmlux fil- friża Ipproteġi mid- dawl
SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA 'PRODOTTI MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM "GĦAL TRATTAMENT TA ’ L- ANNIMALI BISS ” U KUNDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVISTA JEW L- UŻU, jekk applikabbli
For animal treatment only – to be supplied only on veterinary prescription
Għall- kura tal- annimali biss - għandu jingħata biss bi preskrizzjoni veterinarja.
13 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
13 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
Bottle of 10 and 50 ml
Flixkun ta ’ 10 u 50 ml
BTV 8 antigen.................................................................................................................. ...≥ 7.1 CCID50
antiġen BTV8............................................................................................................. > 7. 1 CCID50 *
10 doses (10 ml) 50 doses (50 ml)
10 dożi (10ml) 50 doża (50ml)
ROUTE(S) OF ADMINISTRATION
MOD1 TA ’ AMMINISTRAZZJONI
Withdrawal period: zero days
Żmien ta ’ Tiżmim: xejn
EXP {month/ year} Once broached, use immediately
EXP {xahar/ sena} Jekk infetaħ uża immedjatament
THE WORDS “ FOR ANIMAL TREATMENT ONLY”
IL- KLIEM "GĦAL TRATTAMENT TAL- ANNIMALI BISS ”
For animal treatment only.
Għall- kura tal- annimali biss.
14 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
14 DETTALJI LI GĦANDHOM JIDHRU FUQ IL- PAKKETT EWLIENI
Bottle of 100 ml
flixkun ta ’ 100 ml
Each dose of 1ml of vaccine contains Bluetongue virus serotype 8 antigen............... ...≥ 7.1 CCID50
Kull doża ta ’ millilitru ta ’ vaċċin fiha antiġen tal- virus tal- Bluetongue tas- serotip 8 CCID50 *
Read package leaflet before use
Aqra l- fuljett ta ’ tagħrif li jinsab fil- pakkett qabel tuża ’.
100 doses (100 ml)
100 doża (100 ml)
Active immunisation of sheep and cattle to prevent viraemia and clinical signs caused by the bluetongue virus serotype 8.
Immunizzazzjoni attiva ta ’ nagħaġ u bovini għall- prevenzjoni kontra viremja u sinjali kliniċi ikkawżati mill- virus tal- bluetongue serotip 8.
Read the package leaflet before use.
Taħt il- ġilda Aqra l- fuljett ta ’ tagħrif li jinsab fil- pakkett qabel tuża ’.
EXP {month/ year} Once broached, use immediately
EXP {xahar / sena} La darba jinfetaħ uża immedjatament
Do not freeze Protect from light.
Aħżen u ttrasporta ġo friġġ (2°C – 8°C) Tagħmlux fil- friża Ipproteġi mid- dawl
Read package leaflet before use
Aqra l- fuljett ta 'tagħrif fil- pakkett qabel tuża.
17 PACKAGE LEAFLET FOR:
17 FULJETT TA ’ TAGĦRIF FIL- PAKKETT
Marketing authorisation holder:
Sid l- Awtorizzazzjoni tal- Kummerċ:
MERIAL Laboratory of Lyon Porte des Alpes Rue de l’ Aviation, 69800 Saint-Priest France
MERIAL Laboratorju ta ’ Lyon Porte des Alpes Rue de l’ Aviation 69800 Saint- Priest France
Each dose of 1 ml of vaccine contains:
Kull doża ta ’ millilitru ta ’ vaċċin fiha: • antiġen tal- virus tal- Bluetongue tas- serotip 8.................. > 7. 1 CCID50 *
• •
• Aluminju hydroxide......................................................
Bluetongue virus serotype 8 antigen ....................................................................≥ 7.1 CCID50* Aluminium hydroxide ........................................................................................................2.7 mg
2. 7mg
Saponin................................................................................................................................
Saponin......................................................................................
30 HU** (*) 1 equivalent to titre prior to inactivation (log10) (**) Haemolytic units
30HU ** (*) ekwivalenti għal titru qabel l- inattivazzjoni (log10) (**) unitajiet emolitiċi
Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8 (BTV 8). *below the level of detection by the validated RT-PCR method at 3.14log10 RNA copies/ml, indicating no infectious virus transmission
Immunizzazzjoni attiva ta ’ nagħaġ u bovini għall - prevenzjoni kontra viremja *, u għat- tnaqqis ta ’ sinjali kliniċi ikkawżati mill- virus tal- bluetongue serotip 8 (BTV8). * taħt il- livell li jista ’ jitkejjel bil- metodu ikkonfermat RT/ PCR 3. 14log10 RNA kopji/ ml, li jindika l - ebda trasmissjoni tal- virus infettiv
Vaccination may be followed by a small local swelling at the injection site (at most 32 cm²) for a short period (at most 14 days).
Wara t- tilqim jista ’ jkun hemm nefħa żgħira fil- post tal- injezzjoni (massimu ta ’ 32 cm2) għal żmien qasir (massimu ta ’ 14- il ġurnata).
A transient increase in body temperature, normally not exceeding an average of 1.1°C, may occur within 24 hours after vaccination.
Sa ’ 24 siegħa mit- tilqima, jista ’ jkun hemm żieda transitorja fit- temperatura, normalment ta ’ mhux aktar minn medja ta ’ 1. 1ºC.
Sheep and cattle.
Nagħaġ u bovini.
- 2nd injection: after 3-4 weeks.
- It- tieni injezzjoni: wara 3- 4 ġimgħat
• Revaccination As the duration of immunity is not yet fully established in cattle or sheep, any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Tilqim mill- ġdid Peress li t- tul tal- immunità ghadu m’ hux kompletament stabbilit fil- bovini jew fin- nagħaġ kwalunkwe skema ta ’ tilqim mill- ġdid għandha tkun miftiehma mal- Awtorita ’ Kompetenti jew il- veterinarju responsabbli wara li tittieħed in konsiderazzjoni is- sitwazzjoni epidemjoloġika lokali.
Shake gently immediately before use.
Ħawwad il- vaċċin bil- mod eżatt immedjatament qabel l- użu.
Zero days.
Xejn
19 Shelf life after first opening the immediate packaging: immediately after broaching Do not use after the expiry date (EXP) which is stated on the carton and the label.
Żmien li l- prodott jibqa ’ tajjeb wara li jkun infetaħ il- pakkett ewlieni ghall- ewwel darba: immedjatament wara li jinfetaħ Tużax wara d- data ta ’ l- iskadenza li tidher fuq il- pakkett u t- tikketta.
SPECIAL WARNINGS
TWISSIJIET SPEĊJALI
Can be used during pregnancy in ewes.
Jista 'jintuża fuq in- nagħġa tqila.
Safety throughout pregnancy in cows is not yet fully established however interim results demonstrate safety in at least the last trimester of pregnancy in cows.
Is- sigurtà waqt it- tqala fil- baqar għadu ma ġiex kompletament stabbilit iżda ir- riżultati mhux finali juru sigurtà għall- inqas fl- aħħar terz tat- tqala fil- baqar.
In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/ or national Competent Authorities on the current vaccination policies against Bluetongue Virus (BTV).
F’ din il- kategorija ta ’ annimali il- vaċċin għandu jiġi użat biss skond kif il- veterinarju responsabbli u/ jew l- awtoritajiet kompetenti nazzjonali fuq il- programmi kurrenti dwar it- tilqim kontra l- virus tal- Bluetongue (BTV) iqisu il- benefiċċju / riskju tal- prodott.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
M' hemmx informazzjoni fuq is- sigurtà u l- effikaċja ta ’ dan il- vaċċin meta jintuża flimkien ma kwalunkwe prodott mediċinali veterinarju ieħor.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be decided on a case by case basis.
Għaldaqstant id- deċisjoni biex jintuża dan il- vaċċin qabel jew wara kwalunkwe prodott mediċinali veterinarju ieħor għandha tittieħed skond il- każ partikolari.
No adverse reactions except those mentioned in section ‘adverse reaction’ were observed after the administration of a double-dose of vaccine.
L- ebda reazzjoni avversa, ħlief dawk imsemmiija fis- sezzjoni 4. 6, ma ntweriet wara li ngħatat doża doppja tat- tilqima.
If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Jekk il- prodott jintuża fi speċi ruminanti oħra domestiċi u slavaġ li huma kkunsidrati f’ riskju ta ’ infezzjoni, l- użu f’ dawn l- ispeċi għandu jsir b’ attenzjoni u huwa rrikmandat li l- vaċċin jiġi ittestjat fuq numru żgħir ta ’ annimali qabel it- tilqim kollu f’ daqqa.
Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jiġu mormija ma ’ l- ilma maħmuġ jew ma ’ l- iskart domestiku.
Ask your veterinary surgeon how to dispose of medicines no longer required.
Staqsi lil veterinarju tiegħek dwar kif l- aħjar li tarmi l- mediċini li ma jkunux aktar meħtieġa.
These measures should help to protect the environment.
Dawn il - miżuri għandhom jgħinu sabiex jipproteġu l- ambjent.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Informazzjoni dettaljata dwar dan il- prodott tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /.
Not all pack sizes may be marketed
Mhux id- daqsijiet kollha tal- pakkett jistgħu jitpoġġu fis- suq.
20 Box of 1 bottle of 10 doses (1 x 10 ml) Box of 1 bottle of 50 doses (1 x 50 ml) Box of 10 bottles of 50 doses (10 x 50 ml) Box of 1 bottle of 100 doses (1 x 100 ml) Box of 10 bottles of 100 doses (10 x 100 ml)
Kaxxa ta ’ flixkun ta ’ 10 dożi (1 x 10 ml) Kaxxa ta ’ flixkun ta ’ 50 doża (1 x 50 ml) Kaxxa ta 10 fliexken ta ’ 50 doża (10 x 50 ml) Kaxxa ta ’ flixkun ta ’ 100 doża (1 x 100 ml) Kaxxa ta ’ 10 fliexken ta ’ 100 doża (10 x 100 ml)
1 TABLETS
1 PILLOLI
Cerenia 16 mg tablets for dogs Cerenia 24 mg tablets for dogs Cerenia 60 mg tablets for dogs Cerenia160 mg tablets for dogs
Cerenia 16 mg pilloli għal klieb Cerenia 24 mg pilloli għal klieb Cerenia 60 mg pilloli għal klieb Cerenia 160 mg pilloli għal klieb
Each tablet contains 16 mg, 24 mg, 60 mg or 160 mg maropitant as maropitant citrate monohydrate.
Kull pillola fiha 16 mg, 24 mg, 60 mg jew 160 mg maropitant bħala ċitrat monoidrat ta ’ maropitant.
Each tablet contains 0.075% w/ w Sunset Yellow (E110) as a colourant For a full list of excipients, see section 6.1.
Kull pillola fiha 0. 075% w/ w Sunset Yellow (E110) bħala kolorant Għal- lista sħiħa ta ’ l- ingredjenti (mhux attivi), ara s- sezzjoni 6. 1.
Pale orange tablet The tablets have a score line on both sides allowing the tablet to be halved.
Il- pilloli fihom linja għall- qsim fuq kull naħa biex il- pillola tkun tista ’ tinqasam fi tnejn.
Each tablet is marked with the Pfizer logo on the reverse side.
Kull pillola fiha l- marka ta ’ Pfizer fuq in- naħa ta ’ wara.
On the obverse side, each half is marked with the letters “ MPT” and figures denoting the quantity of maropitant.
Fuq in- naħa ta ’ quddiem, kull nofs hu immarkat bl- ittri “ MPT ” u numri li juru il kwantità ta ’ maropitant.
Dogs.
Klieb
For the prevention of vomiting including that induced by chemotherapy.
Għall- prevenzjoni ta ’ remettar anki dak ikkawżat mill- kimoterapija.
For the treatment of vomiting, in conjunction with Cerenia Solution For Injection and in combination with other supportive measures.
Għat- trattament ta ’ remettar, flimkien ma ’ Cerenia Soluzzjoni Għal Injezzjoni u flimkien ma ’ miżuri oħra ta ’ għajnuna.
For the prevention of vomiting induced by motion sickness.
Għall- prevenzjoni ta ’ remettar ikkawżat minn dardir tal- ivvjaġġar.
Vomiting can be associated with serious, severely debilitating conditions including gastrointestinal obstructions; therefore, appropriate diagnostic evaluations should be employed.
Remettar jista ’ jkun ġej minn kundizzjonijiet serji u li jiddebolixxu ħafna, bħal sadd gastro- intestinali; għalhekk iridu jsiru l- eżamijiet li jkun hemm bżonn.
Cerenia tablets have been shown to be effective in the treatment of emesis, however where the frequency of vomiting is high, orally administered Cerenia may not be absorbed before the next vomiting event occurs.
Pilloli Cerenia instabu li huma effettivi għat- trattament ta ’ remettar, imma meta dan iseħħ ta ’ spiss, Cerenia mogħti mill- ħalq jista ’ jkun għadu ma ’ ġiex assorbit qabel ma jerġa ’ jkun hemm remettar.
It is therefore recommended to initiate the treatment of emesis with Cerenia Solution for Injection.
Għalhekk huwa rakkmandat li l- kura għal remetar tibda b’ Cerenia Soluzzjoni Għal Injezzjoni
2 Good veterinary practice indicates that antiemetics should be used in conjunction with other veterinary and supportive measures, such as dietary control and fluid replacement therapy while addressing the underlying causes of the vomiting.
2 Prattika veterinarja tajba titlob li mediċini kontra remettar għandhom jintużaw flimkien ma ’ miżuri oħra ta ’ għajnuna, bħal kontroll tad- dieta u fluid replacement therapy waqt li jiġu indirizzati il- kawżi ta ’ remettar.
The safety of the veterinary medicinal product has not been established in dogs less than 16 weeks of age and in pregnant or lactating bitches.
Is- sigurtà tal- prodott mediċinali veterinarju ma ġietx stabbilita fi klieb ta ’ anqas minn 16- il ġimgħa u fi klieb tqal jew li qed ireddgħu.
Use only according to the benefit/risk assessment by the responsible veterinarian.
Uża biss skond il- valutazzjoni tal- benefiċċju u r- riskju tal- veterinarju responsabbli.
Maropitant is metabolised in the liver and therefore should be used with caution in patients with hepatic disease.
Maropitant jiġi mmetaboliżat fil- fwied u għalhekk għandu jintuża bil- għaqal f’ pazjenti b’ mard fil- fwied.
Cerenia should be used with caution in animals suffering from or with predisposition for cardiac diseases as maropitant has affinity to Ca- and K-ion channels.
Cerenia għandha tintuża bil- għaqal f’ annimali li jbatu jew li għandhom tendenza b’ mard tal- qalb billi maropitant għandu affinità għal Ca - u K- ion channels.
Increases of approximately 10% in the QT interval of the ECG were observed in a study on healthy beagle dogs administered 8 mg/kg orally; however, such an increase is unlikely to be of clinical significance.
Fi studju fuq klieb b’ saħħithom tar- razza beagle instab li kien hemm żieda ta ’ bejn wieħed u ieħor 10% fl- intervall QT meta ġew amministrati 8 mg/ kg mill- ħalq; madankollu din iż- żieda m’ għandux ikollha sinifikat kliniku.
Wash hands after use.
Aħsel idejk wara l- użu.
In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.
F’ każ li tibilgħu b’ mod aċċidentali, fittex tabib mal- ewwel u qis li turih il - fuljett ta 'informazzjoni li jkun fih il- pakkett jew it- tikketta.
Incidents of pre-travel vomiting, usually within two hours post-dosing were commonly reported after administration of the 8 mg/kg dose.
Spiss ġew irrapportati każijiet ta ’ remettar qabel l- ivvjaġġar fi żmien sagħtejn wara li tkun ingħatat doża ta ’ 8 mg/ kg.
Use only according to the benefit/risk assessment by the responsible veterinarian, because conclusive reproductive toxicity studies have not been conducted in any animal species.
Uża biss skond il- valutazzjoni tal- benefiċċju u r- riskju tal- veterinarju responsabbli, billi ma sarux studji konklussivi fl- ebda annimal dwar il- ħsara fuq is- sistema ta ’ riproduzzjoni.
Cerenia should not be used concomitantly with Ca-channel antagonists as maropitant has affinity to Ca-channels.
Cerenia m’ għandhiex tintuża flimkien ma ’ Ca- channel antagonists billi maropitant għandu affinità għal Ca- channels.
Maropitant is highly bound to plasma proteins and may compete with other highly bound drugs.
Maropitant jabbina b’ mod qawwi ma ’ proteini fil- plażma u jista ’ jikkompeti ma ’ mediċini oħra li jabbinaw b’ mod qawwi ukoll.
For motion sickness a light meal or snack before dosing is recommended; prolonged fasting before administration should be avoided.
Għal dardir tal- ivvjaġġar huwa rikmandat li tingħata xi ħaġa ħafifa ta ’ l- ikel qabel tingħata d- doża; nuqqas ta ’ ikel fit- tul qabel tingħata l- mediċina għandu jkun evitat.
However, Cerenia tablets should not be administered wrapped or encapsulated in food as this may delay dissolution of the tablet and consequently the onset of efficacy.
B’ danakollu, pilloli Cerenia m’ għandhomx jingħataw mgerba jew miksija bl- ikel billi dan iwassal biex il- pillola ddum aktar biex tinħall u b’ hekk idum ma jkollha effett.
Dogs should be carefully observed following administration to ensure that each tablet is swallowed.
Il- klieb għandhom ikunu osservati sew wara l- amministrazzjoni biex ikun żgurat li kull pillola tkun imbelgħat.
3 For the Treatment and Prevention of Vomiting (except Motion Sickness)
3 Għat- trattament u l- Prevenzjoni ta ’ Remettar (mhux minn Dardir tal- Ivvjaġġar)
To treat or prevent vomiting, Cerenia tablets should be administered once daily, at a dose of 2 mg maropitant per kg bodyweight, using the number of tablets given in the table below.
Għat- trattament u l- prevenzjoni ta ’ remettar, il- pilloli Cerenia għandhom jiġu amministrati darba kuljum f’ doża ta ’ 2 mg maropitant għal kull kg piż, b’ numru ta ’ pilloli kif jidher fit- tabella hawn taħt.
Tablets are breakable along the score line on the tablet.
Il- pilloli jistgħu jinqasmu permezz ta ’ linja għall- qsim li hemm fuq il- pillola.
To prevent vomiting, tablets should be given more than 1 hour in advance.
Għall- prevenzjoni ta ’ remettar, il- pilloli għandhom jingħataw aktar minn siegħa qabel.
The duration of the effect is approximately 24 hours and, therefore, tablets can be given the night before administration of an agent that may cause emesis (e.g. chemotherapy).
L- effett idum bejn wieħed u ieħor 24 siegħa u għalhekk il- pilloli jistgħu jingħataw il- lejl ta ’ qabel ma tingħata xi sustanza li tista ’ tikkawża remettar (e. g. kimoterapija).
Cerenia can be used to treat or prevent vomiting either as tablets or as solution for injection once daily for up to five days.
Cerenia tista ’ tintuża għall- kura jew prevenzjoni ta ’ remettar sew bħala pilloli kif ukoll bħala soluzzjoni għal injezzjoni darba kuljum sa ħamest- ijiem.
Treatment and prevention of vomiting (except motion sickness)
Kura u Prevenzjoni ta ’ Remettar (mhux minn Dardir tal- Ivvjaġġar) Numru ta ’ Pilloli Piż tal- Kelb (kg)
* Correct dose for dogs of less than 3 kg cannot be accurately achieved.
* Doża korretta għal klieb ta ’ anqas minn 3 kg ma tintlaħaqx b’ mod preċiż.
For Prevention of Vomiting induced by Motion Sickness
Għall- Prevenzjoni ta ’ Remettar li jkun ġej minn Dardir tal- Ivvjaġġar
To prevent vomiting induced by motion sickness, Cerenia tablets should be administered once daily, at a dose of 8 mg maropitant per kg bodyweight, using the numbers of tablets given in the table below.
Għall- prevenzjoni ta ’ remettar li jkun ġej minn dardir tal- ivvjaġġar, il- pilloli Cerenia għandhom jiġu amministrati darba kuljum f’ doża ta ’ 8 mg maropitant għal kull kg piż, b’ numru ta ’ pilloli kif jidher fit- tabella hawn taħt.
Tablets should be administered at least one hour before starting the journey.
Il- pilloli għandhom jingħataw mill- anqas siegħa qabel ma jibda ’ il- vjaġġ.
The anti-emetic effect persists for at least 12 hours, which for convenience may allow administration the night before early morning travel.
L- effett anti- emetiku jdum għal ta ’ l- anqas 12- il siegħa, u b’ hekk għall- konvenjenza, il- kura tista ’ tiġi amministrata il- lejl ta ’ qabel vjaġġ kmieni filgħodu.
Treatment may be repeated for a maximum of two consecutive days.
Il- kura tista ’ tiġi ripetuta għal mhux aktar minn jumejn fuq xulxin.
Prevention of motion sickness
Prevenzjoni ta ’ Dardir tal- Ivvjaġġar
Number of Tablets
Numru ta ’ Pilloli Piż tal- Kelb (kg)
4 As the pharmacokinetic variation is large and maropitant accumulates in the body after once daily repeated administration, lower doses than recommended might be sufficient in some individuals and when repeating the dose.
4 Billi hemm varjazzjoni farmakokinetika kbira u billi maropitant jakkumula fil- ġisem wara dożi ripetuti ta ’ darba kuljum, dożi aktar baxxi minn dawk rikmandati jistgħu ikunu biżżejjed f’ xi individwi u meta d- doża tkun ripetuta.
Cerenia tablets were well tolerated when administered for 15 days at dosages up to 10 mg/kg bodyweight per day.
Il- pilloli Cerenia ma kellhomx effetti ħżiena meta ingħataw f’ doża ta ’ 10 mg/ kg piż kuljum għal 15 ijiem.
Clinical signs including vomiting on first administration, excess salivation and watery faeces have been observed when the product has been administered at doses in excess of 20 mg/kg.
Meta l- prodott ingħata f’ dożi ogħla minn 20 mg/ kg, ġew osservati sinjali kliniċi li jinkludu remettar ma ’ l- ewwel amministrazzjoni, salivazzjoni eċċessiva u ħmieġ immerraq.
4.11 Withdrawal period(s)
4. 11 Perjodu( i) ta 'Tiżmim
Antiemetics and Antinauseants, ATCvet code:
Anti- emetiċi u Anti- nawżjanti, Kodici ATĊ veterinarja:
Maropitant is a potent and selective neurokinin (NK-1) receptor antagonist, which acts by inhibiting the binding of substance P, a neuropeptide of the tachykinin family, in the CNS.
Maropitant huwa antagonist qawwi u selettiv ta ’ neurokinin (NK- 1) receptor, li jaħdem billi ma jħallix l- abbinar fis- sistema nervuża ċentrali ta ’ substance P, neuropeptide tal- familja tachykinin.
Vomiting is a complex process coordinated centrally by the emetic centre.
Remettar huwa proċess kompless li jiġi kkordinat miċ- ċentru emetiku tas- sistema ċentrali.
This centre consists of several brainstem nuclei (area postrema, nucleus tractus solitarius, dorsal motor nucleus of the vagus) that receive and integrate sensory stimuli from central and peripheral sources and chemical stimuli from the circulation and the cerebro-spinal fluid.
Dan iċ - ċentru jikkonsisti minn ħafna nuklei tal- brainstem (area postrema, nukleu tractus solitarius, nukleu motor dorsali tal- vagus) li jirċievu u jintegraw stimuli sensorjali minn sorsi ċentrali u periferali u stimuli kimiċi miċ- ċirkulazzjoni u cerbro- spinal fluid.
Maropitant is a neurokinin 1 (NK1) receptor antagonist, which acts by inhibiting the binding of substance P, a neuropeptide of the tachykinin family.
Maropitant huwa antagonist ta ’ neurokinin (NK1) receptor, li jaħdem billi ma jħallix l- abbinar ta ’ substance P, neuropeptide tal- familja tachykinin.
Substance P is found in significant concentrations in the nuclei comprising the emetic centre and is considered the key neurotransmitter involved in vomiting.
Substance P tinstab f’ konċentrazzjonijiet sinifikattivi fin- nuklei li jiffurmaw iċ- ċentru emetiku u hija ikkunsidrata in- newrotransmitter l- aktar importanti nvoluta fir- remettar.
By inhibiting the binding of substance P within the emetic centre, maropitant is effective against neural and humoral (central and peripheral) causes of vomiting.
Billi ma jħallix l- abbinar ta ’ substance P fiċ- ċentru emetiku, maropitant huwa effettiv kontra remettar ikkawżat b’ mod newrali u ħumorali (ċentrali u periferali).
A variety of in vitro assays have demonstrated that maropitant binds selectively at the NK1 receptor with dose-dependent functional antagonism of substance P activity.
Varjetà ta ’ studji in vitro urew li maropitant jabbina b’ mod selettiv ma ’ NK1 receptor u jantagonizza l - attività ta’ substance P b’ mod dipendenti fuq id- doża.
In vivo studies in dogs demonstrated the anti-emetic efficacy of maropitant against central and peripheral emetics including apomorphine, cisplatin and syrup of ipecac.
Fi studji in vivo fil- klieb l- effett anti- emetiku ta ’ maropitant ġie ddimostrat kontra emetiċi ċentrali u periferali li jinkludu apomorphine, cisplatin u ġulepp ta ’ ipecac.
Maropitant is non-sedative and should not be used as a sedative in motion sickness.
Maropitant mhux sedattiv u m’ għandux jintuża bħala sedattiv f’ dardir tal- ivvjaġġar.
Maropitant is effective against vomiting.
Maropitant huwa effettiv kontra remettar.
Signs of nausea including excessive salivation and lethargy might remain during treatment.
Sinjali ta ’ nawżja li jinkludu salivazzjoni eċċessiva u telqa qawwija, jistgħu jibqgħu waqt il- kura.
The pharmacokinetic profile of maropitant when administered as a single oral dose of 2 mg/kg body weight to dogs was characterised by a maximum concentration (Cmax) in plasma of approximately 81 ng/ml; this was achieved within 1.9 hours post-dosing (Tmax).
Il- profil farmakokinetiku ta ’ maropitant wara li ġie amministrat f’ doża waħda ta ’ 2 mg/ kg piż mill - ħalq lil klieb, kien karateriżżat minn konċentrazzjoni massima (Cmax) fil- plażma ta ’ bejn wieħed u ieħor 81 ng/ ml; din intlaħqet fi żmien 1. 9 siegħat wara d- doża (Tmax).
Peak concentrations were followed by a decline in systemic exposure with an apparent elimination half-life (t0.5) of 4.03 hours.
L- ogħla konċentrazzjonijiet ġew segwiti minn tnaqqis sistemiku b’ half- life apparenti ta ’ eliminazzjoni (t0. 5) ta ’ 4. 03 siegħat.
At a dose of 8 mg/kg, Cmax of 776 ng/ml was reached at 1.7 hours post-dosing.
B’ doża ta ’ 8 mg/ kg, Cmax ta ’ 776 ng/ ml intlaħqet wara 1. 7 siegħat mid- doża.
The elimination half- life at 8 mg/kg was 5.47 hours.
Il- half- life ta ’ eliminazzjoni b’ 8 mg/ kg kien 5. 47 siegħat.
The inter-individual variation in kinetics may be large, up to 70 CV% for AUC.
Il- varjazzjoni fil- kinetika minn individwu għall- ieħor tista ’ tkun kbira, sa 70 CV% għal AUC.
During clinical studies maropitant plasma levels conferred efficacy from 1 hour after administration.
5 Waqt studji kliniċi il- livelli ta ’ maropitant fil- plażma bdew jgħatu effett siegħa wara l - amministrazzjoni.
5 Estimates for the oral bioavailability of maropitant were 23.7% at 2 mg/kg and 37.0% at 8 mg/kg.
Estimi għall- bioavilibilità orali ta ’ maropitant kienu 23. 7% b’ 2 mg/ kg u 37. 0% b’ 8 mg/ kg.
The volume of distribution at steady-state (Vss) determined after intravenous administration at 1 - 2 mg/kg ranged from approximately 4.4 to 7.0 l/kg.
Il- volum ta ’ distribuzzjoni fi steady- state (Vss) imkejjel wara amministrazzjoni fil- vina b’ 1 – 2 mg/ kg varja bejn wieħed u ieħor minn 4. 4 sa 7. 01 l/ kg.
Maropitant displays non-linear pharmacokinetics (AUC increases more than proportionally with increasing dose) when administered orally within the 1 - 16 mg/kg dose range.
Maropitant kellu xejriet farmakokinetiċi li mhumix linjari (AUC jiżdied aktar minn proporzjonalment ma ’ żieda fid- doża) meta amministrat mill- ħalq f’ doża ta ’ bejn 1 – 16 mg/ kg.
Following repeated oral administration for five consecutive days at a daily dose of 2 mg/kg, accumulation was 151%.
Wara amministrazzjoni ripetuta mill- ħalq għal ħamest- ijiem wara xulxin b’ doża darba kuljum ta ’ 2 mg/ kg, l- akkumular kien 151%.
Following repeated oral administration for two consecutive days at a daily dose of 8 mg/kg, accumulation was 218%.
Wara amministrazzjoni ripetuta mill- ħalq għal jumejn wara xulxin b’ doża darba kuljum ta ’ 8 mg/ kg, l- akkumular kien 218%.
Maropitant undergoes cytochrome P450 (CYP) metabolism in the liver.
Maropitant jiġi metaboliżat fil- fwied permezz ta ’ cytochrome P450 (CYP).
CYP2D15 and CYP3A12 were identified as the canine isoforms involved in the hepatic biotransformation of maropitant.
CYP2D15 u CYP3A12 kienu identifikati bħala l- forom fil - klieb involuti fil- biotrasformazzjoni ta ’ maropitant fil- fwied.
Renal clearance is a minor route of elimination, with less than 1% of an 8 mg/kg oral dose appearing in the urine as either maropitant or its major metabolite.
Clearance mill- kliewi huwa mod minuri ta ’ eliminazzjoni, b’ anqas minn 1% ta ’ doża ta ’ 8 mg/ kg mill - ħalq titfaċċa fl- urina bħala maropitant jew il- forma maġġuri tiegħu.
Plasma protein binding of maropitant in dogs is more than 99%.
Abbinar ta ’ maropitant ma ’ proteini fil- plażma fil- klieb huwa ta ’ aktar minn 99%.
Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Sunset Yellow (E110) as a colourant
Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Sunset Yellow (E110) bħala kolorant
2 days.
6. 2 Inkompatibilitajiet
This veterinary medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali veterinarju m’ għandux bżonn ta ’ l- ebda kondizzjoni speċjali sabiex jinħażen.
An unused half tablet should be returned to the opened blister and kept within the cardboard outer.
Nofs pillola mhux użata għandha terġa ’ titpoġġa fil- folja miftuħa u miżmuma fil- kaxxa ta ’ barra tal - kartun.
Cardboard box containing one aluminium-aluminium blister pack, each containing four tablets per pack.
Kaxxa tal- kartun fiha folja aluminju- aluminju waħda u kull pakkett fih erba ’ pilloli.
Cerenia tablets are available in 16 mg, 24 mg, 60 mg and 160 mg strength.
Pilloli Cerenia jiġu b’ saħħa ta ’ 16 mg, 24 mg, 60 mg u 160 mg.
EU/2/06/062/001 (16 mg tablets) EU/2/06/062/002 (24 mg tablets) EU/2/06/062/003 (60 mg tablets) EU/2/06/062/004 (160 mg tablets)
EU/ 2/ 06/ 062/ 001 (Pilloli ta’ 16 mg) EU/ 2/ 06/ 062/ 002 (Pilloli ta ’ 24 mg) EU/ 2/ 06/ 062/ 003 (Pilloli ta ’ 60 mg) EU/ 2/ 06/ 062/ 004 (Pilloli ta ’ 160 mg)
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /.
7 SOLUTION FOR INJECTION
7 SOLUZZJONI GĦAL INJEZZJONI
Cerenia 10 mg/ml solution for injection for dogs.
Cerenia 10 mg/ ml soluzzjoni għal injezzjoni għal klieb
The solution for injection contains 10 mg maropitant per ml as maropitant citrate monohydrate.
Is- soluzzjoni għal injezzjoni fiha 10 mg maropitant għal kull ml bħala ċitrat monoidrat ta ’ maropitant.
The solution for injection contains 3.3 mg/ml metacresol (as preservative).
Is- soluzzjoni għal injezzjoni fiha 3. 3 mg/ ml metacresol (bħala preservattiv)
Solution for injection A clear, colourless to light yellow solution.
Soluzzjoni ċara, bla kulur sa isfar ċar.
For the prevention of vomiting except that induced by motion sickness.
Għall- prevenzjoni ta ’ remettar ħlief dak ġej minn dardir tal- ivvjaġġar.
For the treatment of vomiting, in combination with other supportive measures.
Għat- trattament ta ’ remettar, flimkien ma ’ miżuri oħra ta ’ għajnuna.
Good veterinary practice indicates that antiemetics should be used in conjunction with other veterinary and supportive measures such as dietary control and fluid replacement therapy while addressing the underlying causes of the vomiting.
Prattika veterinarja tajba titlob li mediċini kontra remettar għandhom jintużaw flimkien ma ’ miżuri oħra ta ’ għajnuna, bħal kontroll tad- dieta u fluid replacement therapy waqt li jiġu indirizzati il- kawżi ta ’ remettar.
Although Cerenia has been demonstrated to be effective in both the treatment and prevention of emesis induced by chemotherapy, it was found more efficacious if used preventively.
Għalkemm ġie muri li Cerenia hija effettiva kemm għat- trattament kif ukoll għall- prevenzjoni ta ’ remettar ikkawżat mill- kimoterapija, instabet aktar effettiva jekk tintuża għal prevenzjoni.
Therefore, it is recommended to administer the antiemetic prior to administration of the chemotherapeutic agent.
Għalhekk huwa rikmandat li l- anti- emetiku jiġi amministrat qabel l- amministrazzjoni tas- sustanza kimoterapewtika.
The use of Cerenia solution for injection against vomiting due to motion sickness is not recommended.
L- użu ta ’ Cerenia soluzzjoni għal injezzjoni mhuwiex rikmandat kontra remettar ġej minn dardir tal - ivvjaġġar.
8 4.5 Special precautions for use
8 4. 5 Prekawzjonijiet Speċjali għall- Użu
Cerenia should be used with caution in animals suffering from or with predisposition for cardiac diseases as maropitant has affinity to Ca- and K-ion channels.
Cerenia għandha jintuża bil- għaqal f’ annimali li jbatu jew li għandhom tendenza b’ mard tal- qalb billi maropitant għandu affinità għal Ca - u K- ion channels.
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 lilek innifsek b’ mod aċċidentali, fittex tabib mal- ewwel u qis li turih il- fuljett ta 'informazzjoni li jkun fih il- pakkett jew it- tikketta.
In laboratory studies, maropitant has been shown to be a potential eye irritant.
Studji f’ laboratorju wrew li maropitant jista ’ jkun irritanti għall- għajnejn.
In the case of accidental eye exposure, flush the eyes with plenty of water and seek medical attention
F’ każ li b’ mod aċċidentali jintlaqtu l- għajnejn, laħlaħ l - għajnejn b’ ħafna ilma u fittex attenzjoni medika.
Pain at injection site may occur.
Jista ’ jkun hemm uġiegħ fil- post ta ’ l- injezzjoni.
Maropitant is highly bound to plasma proteins and may compete with other highly bound medicines.
Maropitant jabbina b’ mod qawwi ma ’ proteini fil- plażma u jista ’ jikkompeti ma ’ mediċini oħra li jabbinaw b’ mod qawwi ukoll.
Cerenia solution for injection should be injected subcutaneously, once daily, at a dose of 1 mg/kg bodyweight (1 ml/10 kg bodyweight).
Cerenia soluzzjoni għal injezzjoni għandha tiġi injettata taħt il- ġilda, darba kuljum, f’ doża ta ’ 1 mg/ kg piż (1 ml/ 10 kg piż).
Cerenia can be used to treat or prevent vomiting either as tablets or as solution for injection once daily for up to five days
Cerenia tista ’ tintuża għall- kura jew prevenzjoni ta ’ remettar sew bħala pilloli kif ukoll bħala soluzzjoni għal injezzjoni darba kuljum sa ħamest- ijiem.
To prevent vomiting, Cerenia solution for injection should be administered more than 1 hour in advance.
Għall- prevenzjoni ta ’ remettar, Cerenia soluzzjoni għal injezzjoni għandha tingħata aktar minn siegħa qabel.
The effect duration is approximately 24 h and therefore treatment can be given the night before administration of an agent that may cause emesis e.g. chemotherapy.
L- effett idum bejn wieħed u ieħor 24 siegħa u għalhekk it- trattament jista ’ jingħata il- lejl ta ’ qabel ma tingħata xi sustanza li tista ’ tikkawża remettar e. g. kimoterapija.
9 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
9 Billi hemm varjazzjoni farmakokinetika kbira u billi maropitant jakkumula fil- ġisem wara dożi ripetuti ta ’ darba kuljum, dożi aktar baxxi minn dawk rikmandati jistgħu ikunu biżżejjed f’ xi individwi u meta d- doża tkun ripetuta.
Cerenia solution for injection was well tolerated in dogs injected daily with up to 5 mg/kg (5 times the use dose) for 15 consecutive days (3-times the recommended duration of administration).
Cerenia soluzzjoni għal injezzjoni ma kellhiex effetti ħżiena fi klieb injettati b’ sa 5 mg/ kg (ħames darbiet aktar mid- doża normali) għal 15- il ġurnata wara xulxin (3 darbiet aktar miż- żmien rikmandat ta ’ amministrazzjoni).
Antiemetic, ATCvet code:
Anti- emetiċi u Anti- nawżjanti, Kodici ATĊ veterinarja:
Signs of nausea including excessive salivation and lethargy might remain after treatment.
Sinjali ta ’ nawżja li jinkludu salivazzjoni eċċessiva u telqa qawwija, jistgħu jibqgħu waqt il- kura.
The pharmacokinetic profile of maropitant when administered as a single subcutaneous dose of 1 mg/kg body weight to dogs was characterised by a maximum concentration (Cmax) in plasma of approximately 92 ng/ml; this was achieved within 0.75 hours post-dosing (Tmax).
Il- profil farmakokinetiku ta ’ maropitant wara li ġie amministrat f’ doża waħda ta ’ 1 mg/ kg piż taħt il - ġilda lil klieb, kien karateriżżat minn konċentrazzjoni massima (Cmax) fil- plażma ta ’ bejn wieħed u ieħor 92 ng/ ml; din intlaħqet fi żmien 0. 75 siegħa wara d- doża (Tmax).
Peak concentrations were followed by a decline in systemic exposure with an apparent elimination half-life (t1/2) of 8.84 hours.
L- ogħla konċentrazzjonijiet ġew segwiti minn tnaqqis sistemiku b’ half- life apparenti ta ’ eliminazzjoni (t0. 5) ta ’ 8. 84 siegħat.
During clinical studies maropitant plasma levels conferred efficacy from 1 hour after administration.
Waqt studji kliniċi il- livelli ta ’ maropitant fil- plażma bdew jgħatu effett siegħa wara l - amministrazzjoni.
The bioavailability of maropitant after subcutaneous administration in dogs was 90.7%.
Il- bioavilibilità ta ’ maropitant wara amministrazzjoni taħt il- ġilda fil- klieb kienet 90. 7%.
The volume of distribution at steady-state (Vss) determined after intravenous administration at 1 - 2 mg/kg ranged from approximately 4.4 to 7.0 L/kg.
Il- volum ta ’ distribuzzjoni fi steady- state (Vss) imkejjel wara amministrazzjoni fil- vina b’ 1 – 2 mg/ kg varja bejn wieħed u ieħor minn 4. 4 sa 7. 01 l/ kg.
Maropitant displays linear kinetics when administered subcutaneously within the 0.5 – 2 mg/kg dose range.
Maropitant kellu xejriet farmakokinetiċi li linjari meta amministrat taħt il- ġilda f’ doża ta ’ bejn 0. 5 – 2 mg/ kg.
Following repeated subcutaneous administration of once-daily doses of 1 mg / kg bodyweight for five consecutive days, accumulation was 146%.
10 Wara amministrazzjoni ripetuta taħt il- ġilda għal ħamest- ijiem wara xulxin b’ doża darba kuljum ta ’ 2 mg/ kg, l- akkumular kien 146%.
CYP2D15 and CYP3A12 were identified as the canine isoforms involved in the hepatic biotransformation of maropitant.
CYP2D15 u CYP3A12 kienu identifikati bħala l- forom fil- klieb involuti fil - biotrasformazzjoni ta ’ maropitant fil- fwied.
10 Renal clearance is a minor route of elimination, with less than 1% of a 1 mg/kg subcutaneous dose appearing in the urine as either maropitant or its major metabolite.
Clearance mill- kliewi huwa mod minuri ta ’ eliminazzjoni, b’ anqas minn 1% ta ’ doża ta ’ 1 mg/ kg taħt il- ġilda titfaċċa fl- urina bħala maropitant jew il- forma maġġuri tiegħu.
Sulphobutyl ether β-cyclodextrin (SBECD) Water for injections Metacresol (as preservative)
Sulphobutyl ether β- cyclodextrin (SBECD) Ilma għal injezzjonijiet Metacresol (bħala preservattiv)
Once broached, use within 28 days.
Żmien li l- prodott mediċinali veterinarju jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ: tlett snin Ladarba jittaqqab it- tapp, uża fi żmien 28 ġurnata.
20 ml, amber molded glass type 1 vial, chlorobutyl rubber stopper and aluminium overseal with flip- off button.
20 ml, kunjett tal- ħġieġ kannella ta ’ Tip 1, tapp tal- klorobutil u siġill ta ’ l- aluminju b’ buttuna flip- off.
Each cardboard outer contains 1 vial.
Kull kaxxa tal- kartun fiha kunjett wieħed.
PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
PROJBIZZJONI TA ’ BEJGĦ, PROVISTA, U/ JEW UŻU Mhux Applikabbli.
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SID( IEN) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL - LOTT
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SID( IEN) TA ’ L- AWTORIZZAZZJONI MILL- HRUĠ TAL- LOTT
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifattur( i) responsabbli mill- ħruġ tal- lott.
I. de Pocé 29 route des Industries F-37530 Pocé sur Cisse France
I. de Poce 29 route des Industries F- 37530 Poce sur Cisse Franza
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Is- sid ta ’ din l- awtorizzazzjoni tal- kummerċ għandu jgħarraf lil Kummissjoni Ewropeja dwar il - pjanijiet ta ’ kummerċ għall- prodott awtorizzat b’ din id- deċiżjoni.
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
Not applicable
Mhux appklikabbli
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
16 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
CARDBOARD CARTON / Tablets
KAXXA TAL- KARTUN / Pilloli
Cerenia 16 mg tablets for dogs
Cerenia 16 mg pilloli għal klieb
Each tablet contains 16 mg maropitant as maropitant citrate monohydrate.
Kull pillola fiha 16 mg maropitant bħala ċitrat monoidrat ta ’ maropitant.
The tablets also contain Sunset yellow (E110) as a colourant.
Il- pilloli fihom ukoll Sunset Yellow (E110) bħala kolorant.
2 mg/kg bodyweight for prevention and treatment of vomiting 8 mg/kg bodyweight for motion sickness.
8 mg/ kg piż għal dardir tal- ivvjaġġar.
It is recommended to initiate treatment of emesis with Cerenia Solution for Injection.
Huwa rakkmandat li l- kura għal remetar tibda b’ Cerenia Soluzzjoni għal Injezzjoni.
EXP {month/year}
JISKADI {xahar / sena}
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
IL- KLIEM "GĦAL TRATTAMENT TA ’ L- ANNIMALI BISS ” U KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVISTA U L- UŻU
For animal treatment only - to be supplied only on veterinary prescription
Għal Trattament ta ’ l- Annimali Biss - għandu jingħata biss bi preskrizzjoni medika.