qanastek/EMEA-V3 huggingface dataset:
Masivet is for oral use in dogs and should be given according to your veterinarian’s instructions.
Masivet qiegħed għal użu orali fil- klieb u għandu jingħata skont l- istruzzjonijiet tal- veterinarju tiegħek.
Your veterinarian will tell you what amount is right for your dog.
Il- veterinarju jgħidlek x’ ammont huwa tajjeb għall- kelb tiegħek.
The recommended dose is 12.5 mg/kg (with a dose range of 11-14 mg/kg) once daily as presented in the table below.
Id- doża rakkomandata hija 12. 5 mg/ kg (b’ medda ta ’ dożi ta ’ 11- 14 mg/ kg) darba kuljum kif muri fit - tabella hawn taħt.
In dogs with a bodyweight of less than 15 kg, accurate dosing is not always possible.
Fi klieb li jiżnu inqas minn 15- il kilogramm, mhuwiex dejjem possibbli dożaġġ preċiż.
These dogs may be treated with either 50, 100 or 150 mg, if it is feasible to achieve a target dose of 11-14 mg/kg bw.
Dawn il- klieb jistgħu jiġu ttrattati b’ 50, 100 jew 150 mg, jekk ikun vijabbli sabiex tinkiseb doża fil- mira ta ’ 11- 14 mg/ kilogramm ta ’ piż tal- ġisem.
12.5 mg/kg bw
12. 5 mg/ kg bw
Dose mg/kg
piż ta ’ piż ta ’
If the tablet is regurgitated or vomited within 10 minutes following administration, treatment should be repeated.
Jekk il- pillola tiġi mtellgħa jew rimettuta sa 10 minuti wara l- għoti, it- trattament għandu jiġi ripetut.
If the tablet is regurgitated or vomited later than 10 minutes following administration, treatment should not be repeated.
Jekk il- pillola tiġi mtellgħa jew rimettuta iżjed tard minn 10 minuti wara l- għoti, it- trattament m’ għandux jiġi ripetut.
ADVICE ON CORRECT ADMINISTRATION
PARIR GĦALL- AMMINISTRAZZJONI KORRETTA
How should I administer Masivet to my dog, and for how long?
Kif għandi nagħti Masivet lill- kelb tiegħi, u għal kemm żmien?
The tablets must be administered as a whole and should not be divided, broken or ground.
Il- pilloli għandhom jingħataw sħaħ u m’ għandhomx jiġu maqsuma, miksura jew imfarrka.
If a broken tablet is rejected by the dog after chewing, it should be disposed of.
Jekk pillola mkissra tiġi mneħħija mill- kelb wara li jomgħodha, din għandha tintrema.
If a dose is missed, the next schedule dose should be given as prescribed.
Jekk tinsa tagħti doża, id- doża skedata li jmiss għandha tingħata kif ordnat.
Do not increase or double the dose.
M’ għandekx iżżid jew tirdoppja d- doża.
If more than the prescribed amount of tablets were given, contact your veterinarian.
Jekk jingħata iżjed mill- ammont preskritt ta ’ pilloli, ikkuntattja lill- veterinarju tiegħek.
Duration of treatment will be dependent on the response observed.
It- tul tat- trattament jiddependi fuq ir- rispons osservat.
Treatment should be maintained in the case of stable disease, i.e. static, partial or complete tumour response, provided that the product is sufficiently well tolerated.
It- trattament għandu jinżamm fil- każ ta ’ marda stabbli, jiġifieri rispons statiku, parzjali jew komplet tat- tumur, bil- kundizzjoni li l- prodott ikun ittollerat b’ mod suffiċjentement tajjeb.
In case of tumour progression, efficacy of treatment is unlikely to be successful and the treatment should be reviewed.
Fil- każ ta ’ progressjoni tat- tumur, l- effikaċja tat- trattament mhijiex probabbli li tirnexxi u t- trattament għandu jiġi rivedut.
The treatment should be reviewed after 4 to 6 weeks in order to assess the initial response.
It- trattament għandu jiġi rivedut wara 4 sa 6 ġimgħat sabiex jiġi valutat ir- rispons inizjali.
Long term treatment should be under regular (at least monthly) veterinary control.
It- trattament fit- tul għandu jkun taħt kontroll veterinarju regolari (mill- anqas darba fix- xahar).
25 Can other medications be given while my dog is taking Masivet?
25 Jistgħu jingħataw medikazzjonijiet oħra waqt li l- kelb tiegħi jkun qed jieħu Masivet?
There are some medicines that you should not give to your dog during treatment because together, they might cause serious adverse effects.
Jeżistu ċerti mediċini li m’ għandekx tagħtihom lill- kelb tiegħek waqt it- trattament għaliex flimkien, huma jistgħu jikkawżaw effetti avversi serji.
Concurrent use of substances which are metabolised by CYP450 isoforms may result in higher or lower plasma levels of either masitinib or those substances.
L- użu simultanju ta ’ sustanzi li jiġu metabolizzati minn isoformi CYP450 jista ’ jirriżulta f’ livelli iżjed għoljin jew iżjed baxxi fil- plażma ta ’ masitinib jew ta ’ dawk is- sustanzi.
Tell your veterinarian about all medicines, including over-the-counter products, that you intend to administer to your dog.
Għid lill- veterinarju tiegħek dwar il- mediċini kollha, inklużi l- prodotti li tixtrihom mingħajr riċetta, li beħsiebek tagħti lill- kelb tiegħek.
The efficacy of Masivet might be reduced in dogs previously treated with chemotherapy and/or radiotherapy.
L- effikaċja ta ’ Masivet tista ’ tkun imnaqqsa fi klieb ittrattati qabel bil- kemjoterapija u/ jew bir - radjuterapija.
Keep out of reach and sight of children.
Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
This veterinary medicinal product does not require any special storage conditions Do not use after the expiry date which is stated on the label after “EXP”.
Tużax wara d- data ta ’ skadenza li tidher fuq it- tikketta wara “ JIS ”.
SPECIAL WARNING(S)
TWISSIJA( IET) SPEĊJALI
12.1 Special precautions for use:
12. 1 Prekawzjonijiet speċjali għall- użu:
What are the special precautions for my dog?
X’ inhuma l- prekawzjonijiet speċjali għall- kelb tiegħi?
Dogs should be carefully monitored by your veterinarian (at least every month) and treatment might need to be adjusted or discontinued, if necessary.
Il- klieb għandhom jiġu mmonitorjati b’ attenzjoni mill- veterinarju tiegħek (mill- anqas kull xahar) u t - trattament jista ’ jkollu bżonn jiġi aġġustat jew imwaqqaf, skont il- ħtieġa.
The treatment should be discontinued if any of these signs are observed: anaemia, severe neutropenia, severe renal toxicity, hepatic toxicity and/or severe diarrhoea or vomiting persistent after dose reduction.
It- trattament għandu jiġi mwaqqaf jekk ikunu osservati xi wħud minn dawn is- sinjali: anemija, newtropenija severa, tossiċità renali severa, tossiċità fil- fwied u/ jew dijarea jew rimettar sever li jippersisti wara t- tnaqqis fid- doża.
What are the special precautions to be taken by the person administering Masivet?
X’ inhuma l- prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tagħti Masivet?
The active substance of Masivet can cause skin sensitisation. • Avoid skin contact with faeces, urine, and vomit of treated dogs. • Wear protective gloves while disposing of vomit, urine or faeces of treated dogs. • If broken tablets, vomit, urine or faeces of treated dogs come into contact with the skin, rinse immediately with plenty of water.
Is- sustanza attiva ta ’ Masivet tista ’ tikkawża sensibilizzazzjoni tal- ġilda. • Evita l- kuntatt tal- ġilda mal- ippurgar, l- awrina, u r- rimettar ta ’ klieb ittrattati. • Ilbes ingwanti protettivi meta tarmi r- rimettar, l- awrina jew l- ippurgar ta ’ klieb ittrattati. • Jekk pilloli mkissrin, rimettar, awrina jew ippurgar ta ’ klieb ittrattati jiġu f’ kuntatt mal- ġilda, laħlaħ immedjatament b’ ħafna ilma.
The active substance of Masivet can cause severe eye-irritation and serious damage to the eyes. • Avoid contact with the eyes. • Take care not to touch the eyes before gloves have been removed and disposed of and the hands have been thoroughly washed. • If the product comes into contact with the eyes, rinse immediately with plenty of water.
Is- sustanza attiva ta ’ Masivet tista ’ tikkawża irritazzjoni severa fl- għajnejn u ħsara serja fl- għajnejn. • Evita l- kuntatt mal- għajnejn. • Ħu ħsieb li ma tmissx għajnejk qabel ma tkun neħħejt u rmejt l- ingwant u ħsilt idejk sewwa. • Jekk il- prodott jiġi f’ kuntatt mal- għajnejn, laħlaħ immedjatament b’ ħafna ilma.
People with known hypersensitivity to masitinib should not handle the product.
Persuni b’ sensittività eċċessiva magħrufa m’ għandhomx jimmaniġġaw il- prodott.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
F’ każ ta ’ inġestjoni aċċidentali, fittex parir mediku mill- ewwel u uri l- fuljett ta ’ tagħrif jew it- tikketta lit- tabib.
Children should not have close contact to treated dogs, treated dog faeces or vomit.
It- tfal m’ għandux ikollhom kuntatt mill- qrib ma ’ klieb trattati, ippurgar jew rimettar ta ’ klieb ittrattati.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI, JEKK HEMM BŻONN
Ask your veterinarian how to dispose of medicines no longer required.
Staqsi lill - veterinarju dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
These measures should help to protect the environment.
Dawn il- miżuri jgħinu għall - protezzjoni tal- ambjent
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
DATA META ĠIE APPROVAT L- AĦĦAR DAN IL- FULJETT TA ’ TAGĦRIF
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- websajt tal- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu
The tablets are available in pack sizes of 30 tablets.
Il- pilloli huma disponibbli f’ pakketti ta ’ 30 pillola.
Masivet is a prescription medicine used to treat dog mast cell tumours.
Masivet huwa mediċina bir- riċetta li tintuża għat- trattament ta ’ tumuri tal- mast cell fil- klieb.
Mast cell tumours are cancerous proliferations of mast cells.
It- tumuri tal- mast cell huma proliferazzjonijiet kanċerużi tal- mast cells.
It is a heterogeneous disease which can be relatively innocent or aggressively malignant.
Hija marda eteroġenea li tista ’ tkun relattivament innoċenta jew malinna b’ mod aggressiv.
In certain circumstances, mast cell tumours can be life threatening for your dog.
F’ ċerti ċirkustanzi, it- tumuri tal- mast cell jistgħu jkunu ta ’ theddida għall- ħajja tal- kelb tiegħek.
Masivet might extend the time before the tumours progress.
Masivet jista ’ jtawwal iż- żmien qabel ma jimxi t- tumur.
Special information for the veterinarian
Informazzjoni speċjali għall- veterinarju
Dogs should be monitored carefully and professional judgement should be used to determine the need for dose reduction in the event of possible significant adverse reactions.
Il- klieb għandhom jiġu mmonitorjati b’ attenzjoni u għandu jintuża ġudizzju professjonali biex tiġi stabbilita l- ħtieġa għal tnaqqis fid- doża f’ każ li jista ’ jkun hemm reazzjonijiet avversi sinifikanti.
If UPC ratio > 2, or creatinine > 1.5 upper limit of normal (ULN), or albumin < 0.75 lower limit of normal (LLN) or blood urea nitrogen (BUN) > 1.5 ULN, discontinue treatment.
F’ każ ta ’ riżultati semikwantitattivi pożittivi bid- dipstikk (proteina > 30 mg/ dl), għandha titwettaq analiżi kimika tal- awrina biex jiġi stabbilit il- proporzjon tal- urinary protein creatinine (UPC), u kampjun tad- demm sabiex jitkejlu l- kreatinina, l- albumina u l- blood urea nitrogen (BUN) Jekk il- proporzjon tal- UPC ikun > 2, jew il- kreatinina tkun > 1. 5 il- limitu ta ’ fuq tan- normal (ULN), jew l- albumina tkun < 0. 75 il- limitu ta ’ taħt tan- normal (LLN) jew il- blood urea nitrogen (BUN) > 1. 5 ULN, it- trattament għandu jiġi mwaqqaf.
Monitoring of Protein loss syndrome Perform every month a dipstick urine test.
Monitoraġġ tas- sindromu tat- telf ta ’ Proteina Kull xahar għandu jitwettaq test tal- awrina bid- dipstikk.
In case of positive semi-quantitative dipstick results (protein ≥ 30 mg/dL), perform urinalysis to determine urinary protein creatinine (UPC) ratio.
F’ każ ta ’ riżultati semikwantitattivi pożittivi tad- dipstikk (proteina ≥30 mg/ dL), għandha ssir analiżi kimika tal- awrina biex jiġi stabbilit il - proporzjon tal- urinary protein creatinine (UPC).
27 Anaemia and / or haemolysis Dogs should be carefully monitored for signs of (haemolytic) anaemia.
Anemija u / jew emolisi Il- klieb għandhom jiġu mmonitorjati b’ attenzjoni għal sinjali ta ’ anemija (emolitika).
In case of clinical signs of anaemia or haemolysis, haemoglobin, free bilirubin and haptoglobin should be measured and blood cell counts (including reticulocyte) should be performed.
F’ każ ta ’ sinjali kliniċi ta ’ anemija jew emolisi, għandhom jiġu mkejla l- emoglobina, il- bilirubina libera u l - haptoglobina u għandu jitwettaq għadd taċ- ċelloli tad- demm (inklużi r- retikuloċiti).
Haemolytic anaemia, i.e. haemoglobin < 10 g/dL and haemolysis, i.e. free bilirubin > 1.5 ULN and haptoglobin < 0.1 g/dL, Anaemia due to lack of regeneration, i.e. haemoglobin < 10 g/dL and reticulocytes < 80,000/mm3.
27 Anemija emolitika, jiġifieri emoglobina < 10 g/ dL u emolisi, jiġifieri bilirubina libera > 1. 5 ULN u haptoglobina < 0. 1 g/ dL, Anemija minħabba nuqqas ta ’ riġenerazzjoni, jiġifieri emoglobina < 10 g/ dL u retikuloċiti < 80, 000/ mm3.
Hepatic toxicity (ALT or AST elevation), neutropenia In case of an increase of ALT or AST > 3 ULN, decrease of neutrophil count < 2000/mm3 or any other severe adverse events, treatment should be modified as follows:
Tossiċità tal- fwied (żieda fl- ALT jew fl- AST), newtropenija Fil- każ ta ’ żieda fl- ALT jew fl- AST ta ’ > 3 ULN, tnaqqis fl- għadd ta ’ newtrofili < 2000/ mm3 jew kwalunkwe episodju avvers serju ieħor, it- trattament għandu jiġi modifikat kif ġej:
At the first occurrence, treatment should be interrupted until resolution, then resumed at the same dose level; At the second occurrence of the same event, treatment should be interrupted until resolution; treatment should then be continued with a reduced dose of 9 mg/kg bodyweight/day; At the third occurrence of the same event, treatment should be interrupted until resolution; treatment should then be continued with a dose further reduced to 6 mg/kg/day; Treatment should be discontinued, if severe adverse reactions are still encountered at the 6 mg/kg/day dose.
Mal- ewwel inċidenza, it- trattament għandu jiġi interrott sar- riżoluzzjoni, imbagħad jitkompla bl- istess livell ta ’ doża; Mat- tieni inċidenza tal- istess episodju, it- trattament għandu jiġi interrott sar- riżoluzzjoni; it- trattament imbagħad għandu jitkompla b’ doża mnaqqsa ta ’ 9 mg/ kilogramm ta ’ piż tal- piż/ kuljum; Mat- tielet inċidenza tal- istess episodju, it- trattament għandu jiġi interrott sar- riżoluzzjoni; it- trattament imbagħad għandu jitkompla b’ doża iżjed imnaqqsa għal 6 mg/ kg/ kuljum; It- trattament għandu jitwaqqaf jekk xorta jkun hemm reazzjonijiet avversi severi bid- doża ta ’ 6 mg/ kg/ kuljum.
Summary of thresholds for laboratory evaluations resulting in contra-indication or treatment modification (interruption, dose reduction or discontinuation)
Sommarju tal- limiti massimi għal valutazzjonijiet tal- laboratorju li jirriżultaw f’ kontra - indikazzjoni jew modifika tat- trattament (interruzzjoni, tnaqqis fid- doża jew twaqqif)
CONTRA-
KONTRA -
TREATMENT
TAT -
DOSE REDUCTION
TNAQQIS FID -
TREATMENT
TWAQQIF TAT -
INTERRUPTION
TRATTAMENT
DISCONTINUATION
TRATTAMENT
MANAGEMENT OF HEPATIC TOXICITY (ALT or AST)
ĠESTJONI TAT- TOSSIĊITÀ FIL- FWIED (ALT jew AST)
(2nd/3rd time)
(it- tieni/ tielet darba)
MANAGEMENT OF NEUTROPENIA (Neutrophil counts)
ĠESTJONI TAN- NEWTROPENIJA (għadd ta ’ newtrofili)
2000 /mm3
< 2000 / mm3 < 2000 / mm3
Albumin < 1 LLN
ĠESTJONI TAS- SINDROMU TAT- TELF TA ’ PROTEINA (Albuminemija u/ jew UPC) Albumina < 1 LLN
MANAGEMENT OF HAEMOLYTIC AND AREGENERATIVE ANAEMIA (haemoglobin, bilirubin, haptoglobin, reticulocytes) Haemoglobin < 10g/ dL and either
ĠESTJONI TAL- ANEMIJA EMOLITIKA U TAL- ANEMIJA MINĦABBA NUQQAS TA ’ RIĠENERAZZJONI (emoglobina, bilirubina, haptoglobina, retikuloċiti) Emoglobina < 10g/ dL u jew
Haemoglobin < 10g/dL
bilirubina libera > 1. 5 Emoglobina < 10g/ dL
Not applicable Not applicable
Ma japplikax
free bilirubin > 1.5 ULN and haptoglobin < 0.1g/dl or reticulocytes < 80,000/mm3
haptoglobina < 0. 1g/ dl jew retikuloċiti < 80, 000/ mm3
28 Dose adjustment
Aġġustament fid- doża
The recommended daily dose of 12.5 mg/kg body weight corresponds to the Maximum Tolerated Dose (MTD) that was derived from repeat dose toxicity studies in healthy Beagle dogs.
Id- doża ta ’ kuljum rakkomandata ta ’ 12. 5 mg/ kg ta ’ piż tal- ġisem tikkorrispondi mad- Doża Massima Tollerata (MTD) derivata mill- istudji dwar l- effett tossiku minn dożi ripetuti fi klieb Beagle b’ saħħithom.
In the case of adverse reactions, doses might be reduced to once daily doses of 9 mg/kg bodyweight (range 7.5 – 10.5 mg/kg) or 6 mg/kg bw (range 4.5 – 7.5) according to the tables below.
Fil- każ tar- reazzjonijiet avversi, id- dożi jistgħu jitnaqqsu għal dożi darba kuljum ta ’ 9 mg/ kilogramm ta ’ piż tal- ġisem (medda 7. 5 – 10. 5 mg/ kg) jew 6 mg/ kilogramm ta ’ piż tal- ġisem (medda 4. 5 – 7. 5) skont it- tabelli ta ’ hawn isfel.
9 mg per kg bodyweight
28 9 mg għal kull kilogramm ta ’ piż tal- ġisem
Number of tablets per day Dose mg/kg
Doża mg/ kg
7.7 8.0 8.2 8.3 8.4 8.5 8.5 8. 6 8.6 8.6 8.7 8.7
52. 8 58. 3 58. 3 63. 9 63. 9 69. 4
6 mg per kg bodyweight
9. 5 9. 4 9. 4
mg weight weight
20. 8 2
> 15.0 > 20.8> 29.2> 37.5> 45.8> 54.2 62.5> 70.8> 79.2
20. 8
20.8 29.2 37.5 45.8 54.2 62.5 70.8 79.2
29. 2
6.6 7.2 6.9 6.7 6.5 6.5 6.4 6.4 6.3
> 6 > >
4.8 5.1 5.3 5.5 5.5 5.6 5.6 5.7
54. 2 2. 5 70. 8 79. 2
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid iktar informazzjoni fuq il- bażi tar - Rakkomandazzjonijiet tal- CVMP, aqra d- Diskussjoni Xjentifika (parti wkoll mill- EPAR).
What is Meloxivet?
X’ inhi Meloxivet?
Meloxivet is a white to yellowish opaque oral suspension which is to be given mixed with food.
Meloxivet huwa sospensjoni orali ta ’ kulur opak abjad jagħti fl- isfar li għandha tingħata mħallta ma ’ l - ikel.
Meloxivet contains the active substance meloxicam and exists in 2 different strengths (0.5 and 1.5 mg/ ml, respectively).
Meloxivet fiha sustanza attiva meloxicam u teżisti f’ żewġ qawwiet differenti (0. 5 u 1. 5mg/ ml rispettivament).
Meloxivet is a ‘ generic’: this means that Meloxivet is similar to a ‘ reference veterinary medicine ’ already authorised in the EU (Metacam 1.5 mg/ ml oral suspension).
Meloxivet huwa ‘ ġeneriku ’ dan ifisser li Meloxivet huwa simili għal ‘ mediċina veterinarja ta ’ referenza ’ li hija diġà awtorizzata fl- UE (Metacam 1. 5mg. ml ta ’ sospensjoni orali).
Studies have been carried out to prove that Meloxivet is ‘ bioequivalent ’ to the reference veterinary medicine: this means that Meloxivet is equivalent to Metacam 1.5 mg/ ml suspension in the way it is absorbed and used by the body.
Dan ifisser li Meloxivet huwa ekwivalenti għal Metacam 1. 5mg/ ml ta ’ sospensjoni fil- mod ta ’ kif tiġi assorbita u wżata mill- ġisem.
What is Meloxivet used for?
Għalxiex tintuża Meloxivet?
Meloxivet is used in dogs to relieve inflammation and pain in musculo-skeletal disorders.
Meloxivet tintuża fil- klieb sabiex titnaqqas l- infjammazzjoni u l- uġigħ fil- problemi muskuloskeletali.
It can be used for both acute disorders, such as those seen after an injury, and chronic (long term) disorders.
Tista ’ tintuża kemm biex tikkura problema akuti, bħal dawk li jidhru wara xi leżjoni, u għal problemi kroniċi (fit- tul).
Meloxivet is given to the dog once a day, with food, at the dose of 0.2 mg/ kg on the first day, then as 0.1 mg/ kg afterwards.
Meloxivet jingħata lill- kelb darba kuljum, flimkien ma ’ l- ikel, f’ doża ta ’ 0. 2mg/ kg fl- ewwel jum, u b’ doża ta ’ 0. 1mg għall- ġranet ta ’ wara.
The amount of suspension to be used is measured using a special dosing syringe (provided in the package), and poured on the food.
L- ammont ta ’ sospensjoni li għandha tintuża hija mkejjla billi tintuża siringa speċjali għad- dożaġġ (li hija provduta fil- pakkett), u mitfugħa fl- ikel.
How does Meloxivet work?
Kif taħdem Metroxivet?
Meloxivet contains meloxicam, which belongs to a class of medicines called nonsteroidal anti- inflammatory drugs (NSAIDs).
Meloxivet fiha meloxicam li jagħmel parti minn klassi ta ’ mediċini msejjħa mediċini anti - infjammatorji mhux sterojdi (NSAIDs).
Meloxicam acts by inhibition of prostaglandin synthesis.
Meloxicam jaġixxi billi jinibixxi s- sinteżi tal- prostaglandini.
As the prostaglandins are substances that trigger inflammation, pain, exudation and fever, meloxicam reduces those responses.
Minħabba li l- prostaglandini huma sostanzi li jikkawżaw l- infjammazzjoni, uġigħ, għaraq u deni, meloxicam tnaqqas dawn ir- reazzjonijiet.
How has the effectiveness of Meloxivet been studied?
Kif ġiet studjata l- effikaċja ta ’ Meloxivet?
A study looked at how Meloxivet was absorbed and its effects in the body, in comparison with Metacam 1.5 mg/ ml oral suspension.
Sar studju li ħares lejn kif Meloxivet ġiet assorbita u l- effetti tagħha fil- ġisem, meta mqabbla ma ’ 1. 5mg/ ml ta ’ sospensjoni orali Metacam.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What are the side-effects of Meloxivet?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged X’ inhuma l- effetti sekondarji ta ’ Meloxivet?
Occasional side effects of Meloxivet are those seen with NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools and apathy (lack of vitality).
Effetti sekondarji okkażjonali ta ’ Meloxivet huma dawk li jidhru bil- NSAIDs, bħat- telf ta ’ aptit, rimetter, dijarrea, demm fil- qlalet u apatija (nuqqas ta ’ vitalità).
These side effects occur usually within the first week of treatment and are generally transient (temporary).
Dawn l- effetti sekondarji jidhru normalment matul l- ewwel ġimgħa tat- trattament u huma ġeneralment temporanji.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
X’ inhuma l- prekawzjonijiet għal persuna li tagħti l- mediċina jew tiġi f’ kuntatt ma ’ l- annimal?
People who are hypersensitive (allergic) to NSAIDs should avoid contact with Meloxivet.
Il- persuni li huma allerġiċi għall- NSAIDs għandhom jevitaw il- kuntatt ma ’ Meloxivet.
If the product is swallowed by a person, the advice of a doctor should be sought immediately.
Jekk il- prodott jinbela ’ minn persuna għandu jitfittex parir mediku minnufiħ.
Why has Meloxivet been approved?
Għaliex ġiet approvata Meloxivet?
The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Meloxivet 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, skond ir- rekwiżiti ta ’ l- Unjoni Ewropea, Meloxivet kien jidher bħala bijoekwivalenti għal Metacam 1. 5mg/ ml ta ’ sospensjoni orali.
Therefore the CVMP’ s view was that, as for Metacam 1.5 mg/ ml oral suspension, Meloxivet’ s benefits are greater than its risks when treating inflammation or pain in muscles or joints in dogs and they recommended that Meloxivet should be given a marketing authorisation.
Għalhekk l- opinjoni tas- CVMP kienet li, l- istess bħal Metacam 1. 5 mg/ ml ta ’ sospensjoni orali, il- benefiċċji ta ’ Meloxivet huma akbar mir- riskji tiegħu meta tiġi trattata l - infjammazzjoni jew uġigħ fil- muskoli jew fil- ġogi fil- klieb u rrakomandaw li Meloxivet għandu tingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Meloxivet:
Informazzjoni oħra dwar Meloxivet:
The European Commission granted a marketing authorisation valid throughout the European Union, for Meloxivet to Janssen Pharmaceutica N. V. on 14 November 2007 Information on the prescription status of this product may be found on the label of the carton.
L- Informazzjoni dwar l- istat tal- preskrizzjoni ta ’ dan il- prodott tista ’ jinstab fuq it- tikketta ta ’ dan il- pakkett.
This summary was last updated:
Dan is- sommarju ġie aġġornat l- aħħar fil -.
Page 2/ 2 ©EMEA 2007
Paġna 2/ 2 ©EMEA 2007
Package size
Daqs tal - pakket
amber glass bottle (type III), polypropylene dosing syringe.
flixkun tal- ħġieġ ta ’ lewn safrani (tip III) siringa tad- dożaġġ polypropylene ta ’ lewn safrani.
1 bottle plus dosing syringe
1 flixkun siringa tad - dożaġġ
N/ A
Mhux applikabbli
Meloxivet 0.5 mg/ ml oral suspension for dogs
Meloxivet 0. 5 mg/ ml suspensjoni orali għall- klieb
Composition for 1 ml:
Kompożizzjoni għal 1 ml:
White to yellowish opaque suspension.
Suspensjoni opaka minn bajda sa safranija.
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Għas- solliev ta ’ infjammazzjoni u wġigħ f’ disturbi muskolu- skeletriċi kemm akuti kif ukoll kroniċi.
Do not use in pregnant or lactating dogs.
Tużax fuq klieb tqal jew li qed ireddgħu.
Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Tużax fuq klieb li jkunu jbatu minn disturbi gastrointestinali, bħal irritazzjoni u emorraġija, indeboliment fil- funzjoni epatika, kardijaka jew renali u disturbi emorraġiċi.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Tużax f’ każijiet ta ’ sensittività għall- ingredjent attiv; ingredjenti miżjuda jew ingredjenti oħra.
Do not use in dogs less than 6 weeks of age.
Tużax fuq klieb li jkollhom inqas minn 6 ġimgħat.
If side effects occur, treatment should be discontinued and the advice of the veterinarian should be sought.
Jekk ikun hemm effetti sekondarji, il- kura għandha titwaqqaf u għandu jittieħed il- parir ta ’ veterinarju.
Avoid use in any dehydrated, hypovolaemic or hypotensive dog, as there is a potential risk of increased renal toxicity.
Evita l- użu fi kwalunkwe kelb li jkun deidrat, ipovolaemiku jew ipotensiv, għax hemm riskju potenzjali ta ’ żieda tat- tossiċità renali.
2/ 28 Special precautions to be taken by the person administering the veterinary medicinal product to animals
2/ 30 Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Nies li hu magħruf li għandhom sensittività eċċessiva għal mediċini mhux sterojdi kontra l- infjammazzjoni (NSAIDs) għandhom jevitaw li jmissu mal- prodott mediċinali veterinarju.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
F’ każ li tibla ’ l- prodott b’ mod aċċidentali, fittex tabib mal- ewwel u qis li turih il- fuljett ta ’ informazzjoni jew it- tikketta.
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood and apathy have occasionally been reported.
Reazzjonijiet avversi tipiċi ta ’ NSAIDs bħal nuqqas t’ aptit, rimettar, dijarea, demm moħbi fl- ippurgar u apatija, kienu rrappurati 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 ta ’ kura, u f’ ħafna każijiet jgħaddu malajr u jisparixxu wara t- tmiem tal- kura, iżda f’ każijiet rari ħafna, jistgħu jkunu serji jew fatali.
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 b’ livell għoli ta ’ twaħħil mal- proteini jistgħu jikkompetu għat- twaħħil u għaldaqstant iwasslu għal effetti tossiċi.
Meloxivet must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Meloxivet m’ għandux jingħata flimkien ma ’ NSAIDs jew glukokortikosterojdi oħrajn.
Pre- treatment with anti-inflammatory substances may result in additional or increased adverse reactions and accordingly a treatment-free period with such should be observed for at least 24 hours before commencement of treatment.
Il- kura minn qabel b’ sustanzi anti- infjammatorji tista ’ tirriżulta f’ żieda ta ’ reazzjonijiet avversi jew addizzjonali, u għalhekk għandu jiġi osservat perjodu ta ’ 24 siegħa mingħajr kura b’ mediċini bħal dawn, qabel ma tinbeda l- kura.
The treatment-free period, however, should take into account the pharmacokinetic properties of veterinary products used previously.
Il- perjodu mingħajr kura, madankollu, irid jikkunsidra l- karatteristiċi farmakokinetiċi tal- prodotti veterinarji użati qabel.
To be administered with food.
Biex jingħata ma ’ l- ikel.
Initial treatment is a single dose of 0.2 mg meloxicam/ kg body weight on the first day.
Il- kura tal- bidu hi 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.
Il- kura għandha titkompla darba kuljum bl- għoti orali (f’ intervalli ta ’ 24 siegħa) bid- doża tal- manteniment ta ’ 0. 1 mg ta ’ meloxicam/ kg ta ’ piż tal- ġisem.
Particular care should be taken with regard to the accuracy of dosing.
Għandha tingħata attenzjoni partikolari fir- rigward ta ’ l- eżattezza tad- dożaġġ.
The suspension has to be given with the measuring syringe provided in the package.
Is- suspensjoni għandha tingħata permezz tas- siringa tal- kejl ipprovduta fil- pakkett.
The syringe fits onto the bottle and has a kg-body weight scale which corresponds to the maintenance dose (ie.
Is- siringa taqbel mal- flixkun u għandha skala ta ’ kg- piż tal- ġisem li tikkorrispondi għad- doża tal- manteniment (i. e.
0.1 mg meloxicam/ kg body weight).
0. 1 mg ta ’ meloxicam/ kg ta ’ piż tal- ġisem).
Thus for the first day, twice the maintenance volume will be required.
Għalhekk, fl- ewwel jum, id- doppju tal- volum tal - manteniment ser ikun meħtieġ.
A clinical response is normally seen within 3 - 4 days.
Rispons kliniku ġeneralment ikun osservat fi żmien 3 - 4 ijiem.
Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.
Il- kura għandha titwaqqaf jekk wara perjodu massimu ta ’ 10 ijiem, l- ebda titjib kliniku ma jkun evidenti.
In case of overdose symptomatic treatment should be initiated.
F’ każ ta ’ doża eċċessiva, għandha tinbeda kura sintomatika.
QM01AC06
Prodotti anti- infammatorji u anti- rewmatiċi, Mhux sterojdi, Kodici ATĊ veterinarja QM01AC06
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 mhux sterojdi u anti- infjammatorja (NSAID) tal- klassi oxicam li taġixxi bl- inibizzjoni tas- sintesi ta ’ prostaglandin, u b’ hekk teżerċita effetti anti- infjammatorji, analġesiċi, anti- exudative, 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 Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are obtained after approximately 6.1 hours.
Assorbiment Meloxicam huwa kompletament assorbit wara l- għoti orali u l- ogħla konċentrazzjonijiet fil- plażma jinkisbu wara madwar 6. 1 sigħat.
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.
Meta l- prodott jintuża skond il- kors tad- dożaġġ rakkomandat, il- konċentrazzjonijiet fl- istat fiss ta ’ meloxicam fil- plażma jintlaħqu fit- tieni jum tal- kura.
Distribution There is a linear relationship between the dose of meloxicam administered and plasma concentration observed in the therapeutic dose range.
Distribuzzjoni Hemm relazzjoni lineari bejn id- doża ta ’ meloxicam mogħtija u l- konċentrazzjoni fil- plażma osservata fil- firxa tad- doża terapewtika.
The volume of distribution is 0.3 1/ kg.
Il- volum tad- distribuzzjoni hu ta ’ 0. 3 l/ kg.
Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites.
Meloxicam huwa metabolat f’ alkoħol, derivattiv ta ’ l- aċidu u f’ diversi metaboliti polari.
Approximately 75% of the administered dose of meloxicam is eliminated via faeces and the remainder via urine.
Madwar 75% tad- doża ta ’ Meloxicam li tingħata titneħħa fl- ippurgar, u l- bqija fl- awrina.
microcrystalline cellulose xanthan gum carboxymethylcellulose sodium benzoate sodium saccharinate glycerol sorbitol citric acid monohydrate sodium hydroxide purified water
microcrystalline cellulose xanthan gum carboxymethylcellulose sodium benzoate sodium saccharinate glycerol sorbitol citric acid monohydrate sodium hydroxide ilma ppurifikat
None known.
M’ hemm xejn magħruf.
4/ 28 6.3 Shelf life
4/ 30 6. 3 Żmien ta ’ kemm il- prodott idum tajjeb
Shelf life after first opening the immediate packaging:
Żmien li l- prodott jibqa ’ tajjeb wara li jkun tneħħa mill- ewwel ippakkjar:
10 ml: amber glass bottle (type III) with polyethylene child resistant closure, polyethylene insert and amber polypropylene dosing syringe.
10 ml: flixkun tal- ħġieġ ta ’ lewn safrani (tip III) b’ għatu tal- polyethylene li jirreżisti l- ftuħ mit- tfal, insert tal- polyethylene u siringa tad- dożaġġ tal- polypropylene ta ’ lewn safrani.
30 ml: amber glass bottle (type III) with polypropylene child resistant closure, polyethylene insert and amber polypropylene dosing syringe.
30 ml: flixkun tal- ħġieġ ta ’ lewn safrani (tip III) b’ għatu tal- polypropylene li jirreżisti l- ftuħ mit- tfal, insert tal- polyethylene u siringa tad- dożaġġ tal- polypropylene ta ’ lewn safrani.
Turnhoutseweg 30 B-2340 Beerse, Belgium Tel: +32(0)14.60.21.11 Fax: +32(0)14.60.21.00
Turnhoutseweg 30 B- 2340 Beerse, il- Belġju Tel: +32( 0) 14. 60. 21. 11 Fax: +32( 0) 14. 60. 21. 00
Meloxivet 1.5 mg/ ml oral suspension for dogs
Meloxivet 1. 5 mg/ ml suspensjoni orali għall- klieb
6/ 28 Special precautions to be taken by the person administering the veterinary medicinal product to animals
6/ 30 Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali
8/ 28 6.3 Shelf life
8/ 30 6. 3 Żmien ta ’ kemm il- prodott idum tajjeb
10 ml presentation: amber glass bottle (type III) with polyethylene child resistant closure, polyethylene insert and clear polypropylene dosing syringe.
Preżentazzjoni ta ’ 10 ml: flixkun tal- ħġieġ ta ’ lewn safrani (tip III) b’ għatu tal- polyethylene li jirreżisti l- ftuħ mit- tfal, insert tal- polyethylene u siringa tad- dożaġġ tal- polypropylene ta ’ lewn ċar.
30 ml and 150 ml presentation: amber glass bottle (type III) with polypropylene child resistant closure, polyethylene insert and clear polypropylene dosing syringe.
Preżentazzjoni ta ’ 30 ml u 150 ml: flixkun tal- ħġieġ ta ’ lewn safrani (tip III) b’ għatu tal- polypropylene li jirreżisti l- ftuħ mit- tfal, insert tal- polyethylene u siringa tad- dożaġġ tal- polypropylene ta ’ lewn ċar.
9/ 28 ANNEX II
9/ 30 ANNESS II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SID/ SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L - AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL- PROVVISTA JEW L- UŻU
Estrada Consiglieri Pedroso, 69 B Queluz de Baixo 2730-055 Barcarena Portugal
Estrada Consiglieri Pedroso, 69 B Queluz de Baixo 2730- 055 Barcarena Il- Portugall
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL - KUMMERĊ FUQ IL- PROVVISTA JEW L- UŻU
11/ 28 ANNEX III
11/ 30 ANNESS III
13/ 28 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
13/ 30 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton box for bottle 10 and 30 ml
Kaxxa tal- kartun għal flixkun ta ’ 10 u 30 ml
0.5 mg 1 mg
0. 5 mg 1 mg
Acute and chronic musculo-skeletal disorders.
Disturbi muskolu- skeletriċi akuti u kroniċi
Do not use in pregnant or lactating dogs
Tużax fuq klieb tqal jew li qed ireddgħu.
EXP Once opened, use within 6 months.
JIS La darba jinfetaħ uża fi żmien 6 xhur.
Dispose of waste material in accordance with local requirements.
Armi l- iskart skond kif jitolbu l- liġijiet lokali.
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- PROVVISTA U L- UŻU, jekk applikabbli
Turnhoutseweg 30 B-2340 Beerse, Belgium
Turnhoutseweg 30 B- 2340 Beerse, il- Belġju
15/ 28 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
15/ 30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
Label bottle 10 and 30 ml
Tiikketta tal- flixkun ta ’ 10 u 30 ml
Meloxicam 0.5 mg/ ml
Meloxicam 0. 5 mg/ ml
THE WORDS “ FOR ANIMAL TREATMENT ONLY”
IL- KLIEM “ GĦAL TRATTAMENT TA ’ L- ANNIMALI BISS ”
16/ 28 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
16/ 30 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton box for bottle 10, 30 and 150 ml
Kaxxa tal- kartun għal flixkun ta ’ 10, 30 u 150 ml
1.5 mg 1 mg
1. 5 mg 1 mg
18/ 28 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
18/ 30 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
Label bottle 150 ml
Tikketta tal- flixkun ta ’ 150 ml
20/ 28 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
20/ 30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
22/ 28 PACKAGE LEAFLET FOR:
22/ 30 FULJETT TA ’ TAGĦRIF FIL- PAKKETT GĦAL:
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ, U L- ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L- KONSENJA TMUR FIS- SUQ, JEKK DIFFERENTI
Janssen Pharmaceutica N. V.
Janssen Animal Health B. V. B. A.
Do not administer Meloxivet:
Tagħtix Meloxivet:
- if your dog is pregnant or during lactation
- jekk il- kelba tiegħek hi tqila jew qed tredda ’
- if your dog is suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
- jekk il- kelb tiegħek qed ibati minn disturbi gastrointestinali, bħal irritazzjoni u emorraġija,
hepatic, cardiac or renal function and haemorrhagic disorders
indeboliment fil- funzjoni epatika, kardijaka jew renali u disturbi emorraġiċi.
- if your dog is hypersensitive (allergic) to the active substance or to any of the other ingredients.
- jekk il- kelb tiegħek għandu sensittività eċċessiva (allerġiku) għal sustanza attiva jew għal xi
- if your dogs is less than 6 weeks of age
- jekk il- kelb tiegħek għandu inqas minn 6 ġimgħat
Typical adverse reactions of non-steroidal anti-inflammatory drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood and apathy have occasionally been reported.
Reazzjonijiet avversi tipiċi ta ’ mediċini mhux sterojdi kontra l- infjammazzjoni (NSAIDs) bħal nuqqas t’ aptit, rimettar, dijarea, demm moħbi fl- ippurgar u apatija, kienu rrappurati xi kultant.
Dosage Initial treatment is a single dose of 0.2 mg meloxicam/ kg body weight on the first day.
Dożaġġ Il- kura tal- bidu hi doża waħda ta ’ 0. 2 mg ta ’ meloxicam/ kg ta ’ piż tal- ġisem fl- ewwel jum.
Route and method of administration
Rotta u metodu ta ’ kif għandu jingħata
Shake bottle well.
Ċaqlaq il- flixkun tajjeb.
Push down and unscrew bottle top.
Imbotta ’ l isfel u ħoll l- għatu tal - flixkun.
Attach the dosing syringe to the bottle by gently pushing the end onto the top the bottle
Waħħal is - siringa tad- dożaġġ mal- flixkun billi timbotta bil- mod it - tarf tagħha fuq in - naħa ta ’ fuq tal - flixkun
Turn the bottle syringe upside down.
Aqleb is- siringa tal - flixkun ta ’ taħt fuq.
Pull the plunger out until the black on the plunger corresponds to your dog’ s bodyweight in kilograms.
Iġbed il- planġer ’ il barra sakemm l- iswed fuq il- planġer jikkorrispondi għal piż tal- ġisem f’ kilogrammi tal- kelb tiegħek.
Turn the bottle right way up and with a twisting movement separate the dosing syringe from the bottle.
Dawwar il- flixkun lura kif suppost u b’ moviment ta ’ liwi, issepara s- siringa tad - dożaġġ minn mal - flixkun.
By pushing the plunger in empty the contents of the syringe onto the food.
Billi timbotta l - planġer ’ il ġewwa, battal il- kontenut tas - siringa fuq l- ikel.
Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.
Il- kura għandha titwaqqaf jekk wara perjodu massimu ta ’ 10 ijiem jekk l- ebda titjib kliniku ma jkun evidenti.
After each dose, the tip of the syringe should be wiped and the bottle cap screwed back on tightly.
Wara kull doża, it- tarf tas- siringa għandu jintmesaħ u l- għatu tal- flixkun għandu jitpoġġa lura f’ postu u jkun issikkat tajjeb.
The syringe should be stored in the carton box in between uses.
Is- siringa għandha tinħażen fil- kaxxa tal- kartun bejn l- għoti tad- dożi.
Do not use after the expiry date stated on the label and carton after EXP.
Tużax wara d- data ta ’ skadenza fuq it- tikketta u l- kaxxa tal- kartun wara JIS.
Shelf life after first opening the container:
Iż- żmien kemm idum tajjeb il- prodott wara li jinfetaħ il- kontenitur għall- ewwel darba:
If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Jekk ikun hemm effetti sekondarji, il- kura għandha titwaqqaf u għandu jittieħed il- parir ta ’ veterinarju.
Meloxivet must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Meloxivet 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.
Il- kura minn qabel b’ sustanzi anti- infjammatorji tista ’ tirriżulta f’ żieda ta ’ reazzjonijiet avversi jew addizzjonali, u għalhekk għandu jiġi osservat perjodu ta ’ 24 siegħa mingħajr kura b’ mediċini bħal dawn, qabel ma tinbeda l- kura.
The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Il- perjodu mingħajr kura, madankollu, irid jikkunsidra l- karatteristiċi farmakokinetiċi tal- prodotti veterinarji użati qabel.
In the case of overdose symptomatic treatment should be initiated.
F’ każ ta ’ doża eċċessiva, għandha tinbeda kura sintomatika.
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Nies li huma sensittivi għal NSAIDs għandhom jevitaw li jmissu mal- prodott mediċinali veterinarju.
In case of accidental ingestion, seek medical advice immediately and show this package leaflet or the label to the physician.
F’ każ li tibla ’ l- prodott b’ mod aċċidentali, fittex tabib mal- ewwel u qis li turih il- fuljett ta ’ informazzjoni jew it- tikketta.
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Kwalunkwe prodott mediċinali veterinarju jew materjal għar- rimi li jkun ġej minn prodotti mediċinali veterinarji bħal dawn, għandhom jintremew skond il- ħtiġijiet lokali.
10 ml presentation: amber glass bottle (type III) with polyethylene child resistant closure, polyethylene insert and an amber polypropylenedosing syringe.
Preżentazzjoni ta ’ 10 ml: flixkun tal- ħġieġ ta ’ lewn safrani (tip III) b’ għatu tal- polyethylene li jirreżisti l- ftuħ mit- tfal, insert tal- polyethylene u siringa tad- dożaġġ tal- polypropylene ta ’ lewn safrani.
30 ml presentation: amber glass bottle (type III) with polypropylene child resistant closure, polyethylene insert and an amber polypropylene dosing syringe.
Preżentazzjoni ta ’ 30 ml: flixkun tal- ħġieġ ta ’ lewn safrani (tip III) b’ għatu tal- polypropylene li jirreżisti l- ftuħ mit- tfal, insert tal- polyethylene u siringa tad- dożaġġ tal- polypropylene ta ’ lewn safrani.
25/ 28 PACKAGE LEAFLET FOR:
26/ 30 FULJETT TA ’ TAGĦRIF FIL- PAKKETT GĦAL:
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
L- ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ, U L- ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L- KONSENJA TMUR FIS- SUQ, JEKK DIFFERENTI
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA( I) INGREDJENT( I) OĦRA
- if your dogs is less than 6 weeks of age
waħda mis- sustanzi l- oħra.
6.
- jekk il- kelb tiegħek għandu inqas minn 6 ġimgħat
The syringe should be stored in the carton box in between uses.
Dan il- prodott mediċinali veterinarju m’ għandux bżonn ta ’ kondizzjonijiet ta ’ ħażna speċjali.
30 ml and 150 ml presentation: amber glass bottle (type III) with polypropylene child resistant closure, polyethylene insert and clear polypropyle dosing syringe.
Preżentazzjoni ta ’ 30 ml u 150 ml: flixkun tal- ħġieġ ta ’ lewn safrani (tip III) b’ għatu tal- polypropylene li jirreżisti l- ftuħ mit- tfal, insert tal- polyethylene u siringa tad- dożaġġ tal- polypropyle ta ’ lewn ċar.
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 ta ’ l- annimal tiegħek, ikkuntattja lil- veterinarju tiegħek.
What is Metacam?
X’ inhu Metacam?
Metacam exists as an oral suspension (0.5 mg/ ml, 1.5 mg/ ml and 15 mg/ ml), a solution for injection (5 mg/ ml and 20 mg/ ml) and chewable tablets (1 mg and 2.5 mg).
Metacam exists as an oral suspension (0. 5 mg/ ml, 1. 5 mg/ ml and 15 mg/ ml), a solution for injection (5 mg/ ml and 20 mg/ ml) and chewable tablets (1 mg and 2. 5 mg).
What is Metacam used for?
Għal xiex jintuża Metacam?
Metacam is used to relieve inflammation and pain in both acute and chronic musculo-skeletal disorders.
Metacam jintuża biex itaffi l- infjammazzjoni u l- uġigħ fid- disturbi muskoloskeletriċi tat- tip akut kif ukoll kroniku.
Metacam is used in cattle for acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs; use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle and as supportive therapy in the treatment of acute mastitis, in combination with antibiotics.
Metacam jintuża fil- bhejjem tal- ifrat għall- infezzjoni respiratorja akuta b’ terapija antibijotika xierqa għat- tnaqqis ta ’ sinjali kliniċi; jintuża għad- dijarrea flimkien ma ’ terapija ta ’ idratazzjoni mill- ġdid permezz tal- ħalq biex jitnaqqsu s- sinjali kliniċi fl- għoġiela ta ’ età ‘ l fuq minn ġimgħa u baqar żgħar li ma jkunux qegħdin ireddgħu u bħala terapija ta ’ appoġġ fit - trattament ta ’ mastite akuta, flimkien ma ’ antibijotiċi.
In pigs indications are use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation and for supportive therapy in the treatment of septicaemia and toxaemia around farrowing (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.
Fil- ħnieżer l- indikazzjonijiet jintużaw għat- trattament tad- disturbi lokomotorji mhux infettivi biex jitnaqqsu s- sintomi ta 'zappip u infjammazzjoni u bħala terapija ta' sostenn flimkien ma 'terapija antibijotika xierqa fit- trattament tas- settiċemija (septicaemia) u tossjemija fit- tifrigħ (toxaemia around farrowing) (sindromu tal- mastite- metrite- agalassija [mastitis- metritis - agalactia syndrome]).
Metacam is used in horses and dogs for the relief of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.
Metacam jintuża fiż- żwiemel u l- klieb għat- taffija mill- infjammazzjoni u l- uġigħ kemm fid - disturbi muskoluskelettriċi akuti kif ukoll dawk kroniċi.