qanastek/EMEA-V3 huggingface dataset:
Metacam chewable tablets can be administered with or without food, are flavoured and are taken by most dogs voluntarily.
Il- pilloli li tomgħodhom Metacam jistgħu jingħataw ma ’ l- ikel jew mingħajru, fihom it - togħma u jittieħdu mill- biċċa l- kbira tal- klieb b’ mod voluntarju.
Dose scheme for the maintenance dose:
Numru ta ’ pilloli li tista ’ tomgħodhom
Number of chewable tablets 1 mg 2.5 mg
2. 5 mg
mg/ kg
4. 0 – 7. 0
4.0 – 7.0 7.1 – 10.0 10.1– 15.0 15.1 – 20.0
0. 13 – 0. 1
½ 1 1½ 2
1 – 10. 0 1
0.13 – 0.1 0.14 – 0.1 0.15 – 0.1 0.13 – 0.1
0. 14 – 0. 1
32/ 125 20.
10. 1 – 15. 0
1 – 25.0 1
0. 15 – 0. 1
0.12 – 0.1
15. 1 –
25.1 – 35.0 35.1 – 50.0
20. 1 – 25. 1 – 35. 1 –
0.15 – 0.1 0.14 – 0.1
0. 12 – 0. 1 0. 15 – 0. 1 0. 14 – 0. 1
The use of Metacam oral suspension for dogs may be considered for an even more precise dosing.
L- użu ta ’ Metacam suspensjoni orali għall- klieb tista ’ tkun ikkunsidrata għall- dożaġġ li jkun iktar preċiż.
For dogs weighing less than 4 kg the use of Metacam oral suspension for dogs is recommended.
Għall- klieb li jiżnu inqas minn 4 kg, l- użu ta ’ Metacam suspensjoni orali għall- klieb hi rakkomandata.
Treatment should be discontinued after 10 days if no clinical improvement is apparent.
Rispons kliniku ġeneralment ikun osservat wara 3- 4 ijiem It- trattament għandu jitwaqqaf jekk wara perjodu ta ’ 10 ijiem jekk l- ebda titjib kliniku ma jkun evidenti.
In case of overdosage symptomatic treatment should be initiated.
F’ każ ta ’ doża eċċessiva, għandu jinbeda trattament sintomatiku.
Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATC vet code:
Prodotti anti- infjammatorji u anti- rewmatiċi, mhux sterojdiċi (oxicams) Kodici ATĊ veterinarja:
Metabolism Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound.
34/ 125 Metaboliżmu Il- biċċa l- kbira ta ’ meloxicam jinsab fil- plażma u hu wkoll prodott ewlieni tat- tneħħija biljari, filwaqt li l- awrina fiha biss traċċi tal- kompost prinċipali.
- Solid honey flavour
- Togħma solida ta ’ għasel
Metacam 1 mg chewable tablets: in bottles:
Metacam 1 mg pilloli li tista ’ tomgħodhom fil- fliexken:
3 years in blisters:
3 snin
2 years in blisters:
Metacam 2. 5 mg pilloli li tista ’ tomgħodhom fil- fliexken: sentejn fil- folji:
Do not store above 30°C.
Taħżinx f’ temperaturi ogħla minn 30°C.
1 mg chewable tablets:
Metacam 1 mg pilloli li tista ’ tomgħodhom:
2.5 mg chewable tablets:
Metacam 2. 5 mg pilloli li tista ’ tomgħodhom:
Metacam chewable tablets are supplied in:
Metacam pilloli li tomgħodhom hu fornuti fi:
- Polyethylene bottles containing 100 chewable tablets together with a desiccant and a child-resistant
- Fliexken tal- polyethylene li fihom 100 pillola li tomgħodha, flimkien ma ’ dessikant u għeluq li ma
closure.
jistax jinfetaħx mit- tfal.
- PVDC/ PE/ PVC/ AL child-resistant blisters with 10, 20, 100 or 500 tablets packed in cardboard
- PVDC/ PE/ PVC/ AL folji reżistenti għat- tfal li fihom 10, 20, 100 jew 500 pillola ppakkjati f’ kaxxi tal -
boxes..
kartun.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
35/ 125 6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użati jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Metacam 1 mg chewable tablets for dogs:
Metacam 1 mg pilloli li tomgħodhom għall- klieb:
EU/ 2/ 97/ 004/ 016 100 tablets Blisters:
EU/ 2/ 97/ 004/ 016 100 pillola Folji:
EU/ 2/ 97/ 004/ 024 10 tablets EU/ 2/ 97/ 004/ 017 20 tablets EU/ 2/ 97/ 004/ 018 100 tablets EU/ 2/ 97/ 004/ 019 500 tablets
EU/ 2/ 97/ 004/ 024 10 pilloli EU/ 2/ 97/ 004/ 017 20 pillola EU/ 2/ 97/ 004/ 018 100 pillola EU/ 2/ 97/ 004/ 019 500 pillola
Metacam 2.5 mg chewable tablets for dogs:
Metacam 2. 5 mg pilloli li tomgħodhom għall- klieb:
EU/ 2/ 97/ 004/ 020 100 tablets Blisters:
EU/ 2/ 97/ 004/ 020 100 pillola Folji:
EU/ 2/ 97/ 004/ 025 10 tablets EU/ 2/ 97/ 004/ 021 20 tablets EU/ 2/ 97/ 004/ 022 100 tablets EU/ 2/ 97/ 004/ 023 500 tablets
EU/ 2/ 97/ 004/ 025 10 pilloli EU/ 2/ 97/ 004/ 021 20 pillola EU/ 2/ 97/ 004/ 022 100 pillola EU/ 2/ 97/ 004/ 023 500 pillola
23.03.2006 Date of last renewal:
Data ta ’ l- ewwel awtorizzazzjoni 23. 03. 2006 Data ta ’ l- aħħar tiġdid:
35/ 125 1.
36/ 125 1.
Metacam 0.5 mg/ ml oral suspension for cats
Metacam 0. 5 mg/ ml suspensjoni orali għall- qtates
Meloxicam 0.5 mg (equivalent to 0.017 mg per drop)
Meloxicam 0. 5 mg (ekwivalenti għal 0. 017 mg kull qatra)
Alleviation of inflammation and pain in chronic musculo-skeletal disorders.
Għas- serħan mill- infjammazzjoni u uġigħ f’ mard muskolu- skeletriku kroniku.
Do not use in cats less than 6 weeks of age.
Tużax fuq qtates li għandhom inqas minn 6 ġimgħat.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
Prekawzjonijiet speċjali għall- użu fl- annimali Jekk ikun hemm reazzjonijiet mhux mixtieqa, it- trattament għandu jitwaqqaf u għandu jittieħed il - parir ta ’ veterinarju.
36/ 125 toxicity.
37/ 125 Evita l- użu fi kwalunkwe annimal li jkun deidratat, ipovolaemiku jew ipotensiv, għax hemm riskju potenzjali ta ’ tossiċità tal- kliewi.
Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.
Ir- rispons għat- terapija fit- tul għandu jkun immonitorjat f’ intervalli regolari minn kirurgu veterinarju.
Metacam 0.5 mg/ ml oral suspension for cats should not be used following parenteral injection of meloxicam or any other NSAID as appropriate dosage regimens for such follow-up treatments have not been established in cats.
Metacam 0. 5 mg/ ml suspensjoni orali għal qtates m’ għandux jintuża wara injezzjoni parenterali ta ’ meloxicam jew kwalunkwe korsijiet adattati oħrajn ta ’ dożaġġ ta ’ NSAIDs, għax kuri follow- up bħal dawn ma kienux stabbiliti fil- qtates.
These side effects are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
Fil- qtates, dawn l- effetti sekondarji f’ ħafna każijiet jgħaddu malajr u jisparixxu wara t- tmiem tat- trattament, iżda f’ każijiet rari ħafna, jistgħu jkunu serji jew fatali.
Concurrent administration of potential nephrotoxic drugs should be avoided.
L- għoti flimkien ta ’ mediċini potenzjalment nefrotossiċi għandu jiġi evitat.
The treatment-free period, however, should take into account the pharmacological properties of the products used previously.
Il- perjodu mingħajr trattament, madankollu, irid jikkunsidra l - proprjetajiet farmakoloġiċi tal- prodotti użati qabel.
Initial treatment is a single oral dose of 0.1 mg meloxicam/ kg body weight on the first day.
It- trattament tal- bidu jikkonsisti minn doża orali waħda ta ’ 0. 1 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem fl- ewwel jum.
Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.05 mg meloxicam/ kg body weight.
It- trattament għandu jitkompla darba kuljum bl- għoti orali (f’ intervalli ta ’ 24 siegħa) bid- doża tal- manteniment ta ’ 0. 05 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem.
The recommended dose should not be exceeded.
Id- doża rakkomandata m’ għandhiex tinqabeż.
To be administered orally either mixed with food or directly into the mouth.
Biex jingħata mill- ħalq jew imħallat ma ’ l- ikel jew direttament fil- ħalq.
The suspension can be given using the drop dispenser of the bottle for cats of any body weight.
Is- suspensjoni tista ’ tingħata billi tuża l- qattara tal- flixkun għal qtates ta ’ kwalunkwe piż tal- ġisem.
Alternatively and for cats with a body weight of at least 2 kg, the Metacam measuring syringe (provided in the package) can be used.
Alternattivament, għal qtates b’ piż tal- ġisem ta ’ mill- inqas 2 kg, tista ’ tintuża s- siringa tal- kejl ta ’ Metacam (ipprovduta fil- pakkett).
6 drops / kg body weight
6 qatriet / kg ta ’ piż tal- ġisem Doża tal- manteniment:
3 drops / kg body weight
3 qatriet / kg ta ’ piż tal- ġisem 38/ 125 Il- proċedura tad- dożaġġ bl- użu tas- siringa tal- kejl:
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to the maintenance dose.
Is- siringa teħel mal- qattara tal- flixkun u għandha skala ta ’ kilogramm- piż tal- ġisem li tikkorrispondi għad- doża tal- manteniment.
Thus for initiation of the therapy on the first day, twice the maintenance volume will be required.
Għalhekk, fl- ewwel jum tat- terapija ikun meħtieġ, id- doppju tal- volum ta ’ manteniment.
Treatment should be discontinued after 14 days at the latest if no clinical improvement is apparent.
Rispons kliniku ġeneralment ikun osservat wara 7 ijiem It- trattament għandu jitwaqqaf jekk wara perjodu massimu ta ’ 14- il jum, l- ebda titjib kliniku ma jkun evidenti.
Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at relatively small overdose levels.
Meloxicam għandu marġni ta ’ sigurtà terapewtika żgħira fil- qtates, u sinjali kliniċi ta ’ doża eċċessiva jistgħu jkunu osservati f’ livelli ta ’ doża eċċessiva relattivament żgħar.
In case of overdose, adverse reactions, as listed in Section 4.6, are expected to be more severe and more frequent.
F’ każ ta ’ doża eċċessiva, reazzjonijiet avversi, kif elenkati f’ Sezzjoni 4. 6, huma mistennija li jkunu iktar severi u iktar frekwenti.
5.2 Pharmacokinetic particulars Absorption If the animal is fasted when dosed, the maximal plasma concentrations are obtained after approximately 3 hours.
Assorbiment Jekk l- annimal jkun sajjem meta jingħata d- doża, il- konċentrazzjonijiet massimi fil- plażma jinkisbu wara madwar 3 sigħat.
If the animal is fed at the time of dosing, the absorption may be slightly delayed.
Jekk l- annimal ikun kiel meta jingħata d- doża, l- assorbiment jista ’ jseħħ ftit iktar tard.
Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites.
Meloxicam huwa metabolizzat għal alkoħol, derivattiv ta ’ aċidu u għal diversi metaboliti polari.
Elimination Meloxicam is eliminated with a half-life of 24 hours.
39/ 125 Eliminazzjoni Meloxicam jiġi eliminat b’ half- life ta ’ 24 siegħa.
Approximately 75% of the administered dose is
Madwar 75% tad- doża li tingħata titneħħa fl - ippurgar, u l- bqija fl- awrina.
Due to the loading dose, steady state is reached after 2 days (48h).
Minħabba l- loading dose, l- istat fiss jintlaħaq wara jumejn (48 siegħa).
- - - - - - - - - - -
- Glycerol
Sodium benzoate Sorbitol, liquid Glycerol Saccharin sodium Xylitol Sodium dihydrogen phosphate dihydrate Silica, colloidal anhydrous Hydroxyethylcellulose Citric acid Honey aroma Water, purified
- Sodium dihydrogen phosphate dihydrate
Polyethylene bottle containing 15 ml with a polyethylene dropper, a tamper proof child resistant closure and a polypropylene measuring syringe.
Flixkun tal- polyethylene li fih 15 ml b’ qattara tal- polyethylene, tapp li jirreżisti l- ftuħ mit- tfal żgħar u siringa tal- kejl tal- polypropylene.
The 1 ml measuring syringe has a kg-body weight scale for cats (2 to 10 kg) and has a pictogram showing a cat.
Is- siringa tal- kejl ta ’ 1ml għandha skala ta ’ kilogramm- piż tal- ġisem għall- qtates (minn 2 sa 10 kg) u għandha pictogram li juri qattus.
39/ 125 8.
40/ 125 8.
20.04.2007 Date of last renewal:
20. 04. 2007 Data ta ’ l- aħħar tiġdid:
40/ 125 ANNEX II
41/ 125 ANNESS II
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IS- SID TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
41/ 125 Metacam 5 mg/ ml solution for injection for cattle and pigs
42/ 125 Metacam 5 mg/ ml soluzzjoni għall- injezzjoni għall- baqar u l- majjali
Venus, 26 Can Parellada Industrial 08228 Terrassa Spain
Venus, 26 Can Parellada Industrial 08228 Terrassa Spanja
The Committee for Veterinary Medicinal Products has recommended the inclusion of meloxicam in Annex I of Council Regulation (EEC) No 2377/ 90 in accordance with the following table:
2377/ 90 skond it- tabella li ġejja:
Animal
Speċi ta ’
Target tissues
Tessut fil- mira Provvedimenti
active substance(s)
farmakoloġikament attiva
provisions
oħrajn
Bovine
Baqar
Muscle Liver Kidney Milk
Muskoli Fwied Kliewi Ħalib
Muscle Liver Kidney
Muskoli Fwied Kliewi
Pharmacologically
Sustanza farmakoloġikament
Other
Provvedimenti
active substance(s)
Attiva
species
l- annimal
Ethanol1 Poloxamer 1882 Sodium Chloride3 Glycine4 Sodium Hydroxide5 Water for injection6 Nitrogen7
Ethanol Poloxamer 1882 Sodium Chloride3 Glycine4 Sodium Hydroxide5 Ilma għall- injezzjoni6 Nitrogen7
All food producing species All food producing species All food producing species All food producing species All food producing species All food producing species All food producing species
L- ispeċi kollha li jipproduċu l- ikel L- ispeċi kollha li jipproduċu l- ikel L- ispeċi kollha li jipproduċu l- ikel L- ispeċi kollha li jipproduċu l- ikel L- ispeċi kollha li jipproduċu l- ikel L- ispeċi kollha li jipproduċu l- ikel L- ispeċi kollha li jipproduċu l- ikel
The Committee considered that at the concentration of the dose in the product to be administered to the target species, the excipient glycofurol was not pharmacologically active.
Il- Kumitat ikkunsidra li fil- konċentrazzjoni tad- doża fil- prodott li jrid jingħata lill- ispeċi fil- mira, is - sustanza glycofuran ma kinitx farmakoloġikament attiva.
It therefore concluded, in accordance with its recent position paper on pharmacologically active excipients, that an MRL was not required to be established for this substance.
Għalhekk ikkonkluda li, b’ konformità mal - pożizzjoni riċenti li ħa fuq sustanzi li huma farmakoloġikament attivi, li l- MRL ma kienx meħtieġ li jiġi stabbilit għal din is- sustanza.
Meglumine was not considered within the scope of Council Regulation 2377/ 90 at concentrations up to 1.5 mg/ kg bw (concentrations up to 34.75 mg/ ml).
Meglumine ma kienx ikkunsidrat fi ħdan l- iskop tar- Regolament tal- Kunsill 2377/ 90 f’ konċentrazzjonijiet sa 1. 5 mg/ kg ta ’ piż tal- ġisem (konċentrazzjonijiet sa 34. 75 mg/ ml).
1 OJ No.
1 Nru.
L 143 of 27.06.95 2 OJ No.
ĠU L 143 ta '27. 06. 95 2 Nru.
L 290 of 5.12.95 3 OJ No.
ĠU L 290 ta '5. 12. 95 3 Nru.
L 290 of 5.12.95 4 OJ No.
ĠU L 290 ta '5. 12. 95 4 Nru.
L 272 of 25.10.96 5 OJ No.
ĠU L 272 ta '25. 10. 96 5 Nru.
L 272 of 25.10.96 6 OJ No.
ĠU L 272 ta '25. 10. 96 6 Nru.
L 143 of 27.06.95 7 OJ No.
ĠU L 143 ta '27. 06. 95 7 Nru.
L 272 of 25.10.96
ĠU L 272 ta '25. 10. 96
43/ 125 Metacam 1.5 mg/ ml oral suspension for dogs
44/ 125 Metacam 1. 5 mg/ ml Suspensjoni orali għall- klieb
44/ 125 Metacam 5 mg/ ml solution for injection for dogs and cats
45/ 125 Metacam 5 mg/ ml soluzzjoni għall- injezzjoni għall- klieb u l- qtates
Labiana Life Sciences S. A Venus, 26 Can Parellada Industrial 08228 Terrassa Spain
Labiana Life Sciences S. A Venus, 26 Can Parellada Industrial 08228 Terrassa Spanja
45/ 125 Metacam 20 mg/ ml solution for injection for cattle, pigs and horses
46/ 125 Metacam 20 mg/ ml soluzzjoni għall- injezzjoni għall- baqar, majjali u żwiemel.
Other
Dispożizzjoni -
species
mmirati
provisions
jiet oħrajn
Equidae
Żwiemel
active substance(s)
Dispożizzjonijiet oħrajn
species
Attiva
provisions
l- annimal
Ethanol8 Poloxamer 1889 Macrogol 300 Glycine10 Disodium edetate Sodium Hydroxide11 Hydrochloric acid Water for injection12 Nitrogen13
Ethanol8 Poloxamer 1889 Macrogol 300 Glycine10 Disodium edetate Sodium Hydroxide11 Hydrochloric acid Water for injection12 Nitrogen13
All food producing species All food producing species All food producing species.
L- ispeċi kollha li jipproduċu l- ikel L- ispeċi kollha li jipproduċu l- ikel L- ispeċi kollha li jipproduċu l- ikel.
All food producing species All food producing species All food producing species All food producing species All food producing species All food producing species
L- ispeċi kollha li jipproduċu l- ikel L- ispeċi kollha li jipproduċu l- ikel L- ispeċi kollha li jipproduċu l- ikel L- ispeċi kollha li jipproduċu l- ikel L- ispeċi kollha li jipproduċu l- ikel L- ispeċi kollha li jipproduċu l- ikel
up to 1.5 mg/ kg bw (concentrations up to 34.75 mg/ ml)
Meglumine ma kienx ikkunsidrat fi ħdan l- iskop tar- Regolament tal- Kunsill 2377/ 90 f’ konċentrazzjonijiet sa 1. 5 mg/ kg ta ’ piż tal- ġisem (konċentrazzjonijiet sa 34. 75 mg/ ml)
8 OJ No.
8 Nru.
L 143 of 27.06.95 9 OJ No.
ĠU L 143 ta '27. 06. 95 9 Nru.
L 290 of 5.12.95 10 OJ No.
ĠU L 290 ta '5. 12. 95 10 Nru.
L 272 of 25.10.96 11 OJ No.
ĠU L 272 ta '25. 10. 96 11 Nru.
L 272 of 25.10.96 12 OJ No.
ĠU L 272 ta '25. 10. 96 12 Nru.
L 143 of 27.06.95 13 OJ No.
ĠU L 143 ta '27. 06. 95 13 Nru.
47/ 125 Metacam 15 mg/ ml oral suspension for horses
48/ 125 Metacam 15 mg/ ml suspensjoni orali għaż- żwiemel
The Committee for Veterinary Medicinal Products has recommended the inclusion of Meloxicam in Annex I of Council Regulation (EEC) No 2377/ 90 in accordance with the following table:
2377/ 90 skond it- tabella li ġejja:
Pharmacologically active substance(s)
Sustanza farmakoloġikament attiva
Marker residue
Residwu jimmarka
Animal species MRLs
Speċi annimal
Target tissues
ta ’ MRLs
Other provisions
Tessuti mmirati
Pharmacologically active substance Sorbitol
Sustanza farmakoloġikament attiva Sorbitol
Animal Species Annex II (E420): producing species
Speċi ta ’ Annimal Anness II (E420):
All food
L- ispeċi kollha li jipproduċu l- ikel
Other provisions
Provvedimenti oħrajn
Annex II (E422): producing species
Anness II (E422):
Annex II (E954): producing species
Anness II (E954):
Annex II (E967): producing species
Anness II (E967):
Sodium dihydrogen phosphate dihydrate
Sodium dihydrogen phosphate dihydrate Silica, colloidal anhydrous
Annex II (E339): producing species
Anness II (E339):
Annex II (E551): producing species
L- ispeċi kollha li jipproduċu l- ikel Anness II (E551):
Annex II (E211): producing species
Anness II (E211):
Hydroxyethylcellulose and Water (purified) are not within the scope of Council Regulation (EC) 2377/ 90.
Hydroxyethylcellulose u Ilma (ippurifikat) mhumiex fi ħdan l- iskop tar- Regolament tal- Kunsill (KE) 2377/ 90.
48/ 125 Metacam 0.5 mg/ ml oral suspension for dogs
49/ 125 Metacam 0. 5 mg/ ml suspensjoni orali għall- klieb
49/ 125 Metacam 1 mg chewable tablets for dogs Metacam 2.5 mg chewable tablets for dogs
50/ 125 Metacam 1 mg pilloli li tomgħodhom għall- klieb Metacam 2. 5 mg pilloli li tomgħodhom għall- klieb
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE OF THE PRODUCT
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV
50/ 125 Metacam 0.5 mg/ ml oral suspension for cats
51/ 125 Metacam 0. 5 mg/ ml suspensjoni orali għall - qtates
51/ 125 ANNEX III
52/ 125 ANNESS III
53/ 125 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
54/ 125 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
NAME OF THE VETERINARY MEDICINAL PRODUCT
ISEM TAL- PRODOTT MEDICINALI VETERINARJU
Metacam 5 mg/ ml solution for injection for cattle and pigs Meloxicam
Meloxicam
Acute respiratory infection.
Infezzjoni akuta fis- sistema tan- nifs.
Diarrhoea in calves of over one week of age and young, non-lactating cattle.
Dijarea fl- għoġġiela li jkollhom iktar minn ġimgħa, u baqar frieħ li ma jkunux qed jerdgħu.
Non-infectious locomotor disorders.
Mard mhux infettiv tal- mixi.
Single subcutaneous or intravenous injection.
Injezzjoni waħda taħt il- ġilda jew ġol- vini.
Single intramuscular injection.
Injezzjoni waħda ġol- muskoli.
If required, a second administration can be given after 24 hours.
Jekk ikun meħtieġ, it- tieni doża tista ’ tingħata wara 24 siegħa.
WITHDRAWAL PERIOD
PERJODU TA ’ TIZMIM
Cattle: meat and offal:
Baqar: laħam u ġewwieni ta ’ l- annimali:
Pigs: meat and offal:
Majjali: laħam u ġewwieni ta ’ l- annimali:
EXP {month/ year} Shelf-life of broached vial:
EXP {xahar/ sena} Kunjett miftuħ idum tajjeb:
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 KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVVISTA U L- UZU, jekk applikabbli
MARKETING AUTHORISATION NUMBERS
NUMRU/ I TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
MANUFACTURER´S BATCH NUMBER
NUMRU TAL- LOTT TAL- MANIFATTUR
55/ 125 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
56/ 125 TAGĦRIF LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI
Cattle: subcutaneous or intravenous injection.
Baqar: injezzjoni taħt il- ġilda jew ġol- vini.
Pigs: intramuscular injection.
Majjali: injezzjoni ġol- muskoli.
Once broached, use by...
La darba jinfetaħ uża fi żmien...
Boehringer Ingelheim Vetmedica GmbH Germany
Boehringer Ingelheim Vetmedica GmbH Ġermanja
57/ 125 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
58/ 125 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Metacam 1.5 mg/ ml oral suspension for dogs Meloxicam
Metacam 1. 5 mg/ ml suspensjoni orali għall- klieb Meloxicam
Acute and chronic musculo-skeletal disorders.
Mard muskolu- skeletriku akut u kroniku.
EXP {month/ year} Shelf-life of opened bottle:
EXP {xahar/ sena} Jekk tiftaħ uża fi żmien:
58/ 125 9.
59/ 125 9.
Read the package leaflet before use
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett.
To be supplied only on veterinary prescription.
Għandu jingħata biss bi preskrizzjoni veterinarja
59/ 125 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
60/ 125 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
CONTENT BY WEIGHT; BY VOLUME OR BY NUMBER OF DOSES
KONTENUT BĦALA PIŻ, VOLUM JEW NUMRU TA ’ DOŻI
Once broached, use by …
6 xhur La darba jinfetaħ uża fi żmien...
60/ 125 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
61/ 125 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Metacam 5 mg/ ml solution for injection for dogs and cats Meloxicam
Metacam 5 mg/ ml soluzzjoni għall- injezzjoni għall- klieb u l- qtates Meloxicam
{month/ year} Shelf-life of broached vial:
EXP {xahar/ sena} Kunjett miftuħ idum tajjeb:
62/ 125 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
63/ 125 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
KONTENUT SKOND IL- PIŻ, VOLUM JEW NUMRU TA ’ DOŻI
SC
Klieb: jingħata ġol- vina jew taħt il- ġilda Qtates: jingħata taħt il- ġilda
EXP {month/ year}
EXP {xahar/ sena}
63/ 125 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
64/ 125 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
Metacam 20 mg/ ml solution for injection for cattle, pigs and horses Meloxicam
Meloxicam
PACKAGE SIZE(S)
DAQS TAL- PAKKETT( I)
Acute mastitis.
Mastite akuta.
Puerperal septicaemia and toxaemia (MMA syndrome) with antibiotic therapy.
Settiċemija puwerperali u tossemija (sindrome MMA) flimkien ma ’ terapija antibijotika.
Pain associated with equine colic.
Uġigħ marbut ma ’ kolika ekwina.
Single intravenous injection.
Injezzjoni waħda ġol- vina.
WITHDRAWAL PERIODS
PERJODI TA ’ TIŻMIM
15 days; milk:
15- il jum; ħalib:
Horses: meat and offal:
Żwiemel: laħam u ġewwieni ta ’ l- annimali:
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 KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVVISTA U L- UŻU, jekk applikabbli
66/ 125 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
67/ 125 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
SC or IV injection.
Jingħata b’ injezzjoni taħt il- ġilda jew ġol- vina.
IM injection.
Jingħata b’ injezzjoni ġol- muskoli.
IV injection.
Jingħata b’ injezzjoni ġol- vina.
Once broached, use by …
La darba jinfetaħ uża fi żmien...
68/ 125 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
69/ 125 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
QUANITITY OF THE ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA
SC or IV
Jingħata b’ injezzjoni taħt il- ġilda jew ġol- vina.
IM
Jingħata b’ injezzjoni ġol- muskoli.
IV
Jingħata b’ injezzjoni ġol- vina.
WITHDRAWAL PERIODS
ŻMIEN TA ’ TIŻMIM
69/ 125 8.
70/ 125 8.
70/ 125 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
71/ 125 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Metacam 15 mg/ ml oral suspension for horses Meloxicam
Metacam 15 mg/ ml suspensjoni orali għaż- żwiemel Meloxicam
To be administered either mixed with a small quantity of food, prior to feeding, or directly into the mouth.
Biex jingħata jew jitħallat ma ’ kwantità żgħira ta ’ l- ikel, qabel l- għalf, jew direttamemt fil- ħalq.
{month/ year} Shelf-life of opened bottle:
EXP {xahar/ sena} Jekk tiftaħ uża fi żmien:
71/ 125 10.
72/ 125 10.
72/ 125 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
73/ 125 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
Once broached, use by..............
6 xhur La darba jinfetaħ uża fi żmien...
74/ 125 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
74/ 125 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Metacam 0.5 mg/ ml oral suspension for dogs Meloxicam
Metacam 0. 5 mg/ ml suspensjoni orali għall- klieb Meloxicam
EXP {month/ year} Shelf-life of opened bottle:
EXP {xahar/ sena} La darba jinfetaħ uża fi żmien:
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 KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVVISTA U L- UZU, jekk applikabbli
76/ 125 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
76/ 125 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
CONTENTS BY WEIGHT; BY VOLUME OR BY NUMBER OF DOSES
KONTENUT SKOND IL- PIŻ, VOLUM JEW NUMRU TA ’ DOŻI
For animal treatment only.
Għal trattament ta ’ l- annimali biss
77/ 125 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
77/ 125 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton box of bottle
Kaxxa tal- kartun tal- flixkun
Metacam 1 mg chewable tablets for dogs Meloxicam
Metacam 1 mg pilloli li tomgħodhom għall- klieb Meloxicam
1 mg / chewable tablet
1 mg / pillola li tomgħodha
Single dose on the first day:
Doża waħda fl- ewwel jum:
0.2 mg meloxicam/ kg body weight.
0. 2 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem.
Maintenance dose:
Doża tal- manteniment:
0.1 mg meloxicam/ kg body weight once daily (1 chewable tablet per 10 kg body weight).
0. 1 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem darba kuljum (1 pillola li tomgħodha għal kull 10 kilogrammi ta ’ piż tal- ġisem).
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 KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVVISTA U L- UZU, JEKK APPLIKABBLI
79/ 125 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
79/ 125 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Metacam 2.5 mg chewable tablets for dogs Meloxicam
Metacam 2. 5 mg pilloli li tomgħodhom għall- klieb Meloxicam
2.5 mg / chewable tablet
2. 5 mg / pillola li tomgħodha
0.1 mg meloxicam/ kg body weight once daily (1 chewable tablet per 25 kg body weight).
0. 1 mg meloxicam / kg ta ’ piż tal- ġisem darba kuljum (1 pillola li tomgħodha għal kull 25 kg ta ’ piż tal - ġisem).
81/ 125 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
81/ 125 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton box of blisters
Kaxxa tal- kartun tal- folji
10 tablets 20 tablets 100 tablets 500 tablets
10 pilloli 20 pillola 100 pillola 500 pillola
83/ 125 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
83/ 125 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
85/ 125 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
85/ 125 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
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 KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVVISTA U L- UŻU, JEKK APPLIKABBLI
87/ 125 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
87/ 125 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
89/ 125 MINIMUM PARTICULARS TO APPEAR ON BLISTERS
89/ 125 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI
Metacam 1 mg chewable tablets for dogs
Metacam 1 mg pilloli li tomgħodhom għall- klieb
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
90/ 125 MINIMUM PARTICULARS TO APPEAR ON BLISTERS
90/ 125 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI
Blisters
Infafet
Metacam 2.5 mg chewable tablets for dogs
Metacam 2. 5 mg pilloli li tomgħodhom għall- klieb
91/ 125 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
91/ 125 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Metacam 0.5 mg/ ml oral suspension for cats Meloxicam
Metacam 0. 5 mg/ ml suspensjoni orali għall- qtates Meloxicam
Chronic musculo-skeletal disorders.
Mard muskolu- skeletriku kroniku.
93/ 125 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
93/ 125 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
EXP {month/ year} Shelf-life of opened bottle:
EXP {xahar/ sena} ĠalaJekk tiftaħ uża fi żmien:
Once broached, use by …
6 xhur La darba jinfetaħ, uża safi żmien...
95/ 125 PACKAGE LEAFLET FOR:
95/ 125 FULJETT TA ’ TAGĦRIF FIL- PAKKETT:
Marketing authorisation holder
Sid l- Awtorizzazzjoni tal- Kummerċ
Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/ Rhein Germany
Boehringer Ingelheim Vetmedica GmbH55216 Ingelheim/ Rhein
Labiana Life Sciences S. A.
Sciences S. A.
Venus, 26 Can Parellada Industrial 08228 Terrassa Spain
Can Parellada Industrial 08228 Terrassa Spanja
Ethanol 150 mg/ ml
Ethanol 150 mg/ ml
For 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.
Għall- użu fit- trattament ta ’ dijarea flimkien ma ’ terapija orali ta ’ idratazzjoni mill- ġdid, biex jitnaqqsu s- sintomi kliniċi f’ għoġġiela li għandhom aktar minn ġimgħa jew baqar frieħ ta ’ età żgħira.
Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Tużax f’ annimali li għandhom indeboliment fil- funzjoni tal- fwied, tal- qalb jew tal- kliewi, u mard emorraġiku, jew fejn ikun hemm evidenza ta ’ leżjonijiet gastrointestinali ulċeroġeniċi Tużax f’ każ ta ’ sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
96/ 125 transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
L- għoti taħt l- ġilda, fil- muskolu, kif ukoll ġol- vina hu ittollerat tajjeb; kienet osservata biss nefħa ħafifa li tgħaddi malajr fis- sit ta ’ l- injezzjoni wara l- għoti taħt il- ġilda, f’ inqas minn 10% tal- baqar li kienu ttrattati fi studji kliniċi.
Do not use after the expiry date (EXP) stated on the carton and bottle.
Tużax wara d- data ta ’ l- iskadenza (EXP) fuq il- kartuna u l- flixkun.
Precautions for use in animals If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Prekawzjonijiet għall- użu fl- annimali Jekk ikun hemm reazzjonijiet mhux mixtieqa, it- trattament għandu jitwaqqaf u għandu jittieħed il - parir ta ’ veterinarju.
97/ 125 Precautions to be taken by the person administering the product Accidental self-injection may give rise to pain.
Prekawzjonijiet li għandhom jittieħdu mill- persuna li tamministra l- prodott Injezzjoni aċċidentali tiegħek nnifsek tista ’ tikkaġuna wġigħ.
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.
Use during pregnancy and lactation Cattle:
Użu fit- tqala u fi żmien il- ħalib Baqar:
Pigs:
Qżieqeż:
Interactions Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.
Interazzjonijiet M’ għandux jingħata flimkien ma ’ glukokortikosterojdi, sustanzi oħrajn anti- infjammatorji mhux sterojdiċi u jew ma ’ antikoagulanti.
Overdose In the case of overdosage symptomatic treatment should be initiated.
Doża eċċessiva F’ każ ta ’ doża eċċessiva, għandu jinbeda trattament sintomatiku.
Waste materials should be disposed of in accordance with local requirements.
Materjali għar- rimi għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
Cardboard box with 1 or 12 colourless glass injection vial(s) of 100 ml.
Kaxxa tal- kartun b’ kunjett wieħed jew 12- il kunjett tal- ħġieġ għall- injezzjoni, ta ’ 100 ml, mingħajr kulur.
98/ 125 PACKAGE LEAFLET FOR:
98/ 125 FULJETT TA ’ TAGĦRIF FIL- PAKKETT:
Metacam 1.5 mg/ ml oral suspension for dogs
Metacam 1. 5 mg/ ml suspensjoni orali għall- klieb
Metacam 1.5 mg/ ml oral suspension for dogs Meloxicam
Metacam 1. 5 mg/ ml Suspensjoni orali għall- klieb Meloxicam
Meloxicam 1.5 mg/ ml (equivalent to 0.05 mg per drop)
Meloxicam 1. 5 mg/ ml (ekwivalenti għal 0. 05 mg kull qatra)
Typical adverse drug reactions of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure 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, apatija u insuffiċjenza renali kienu rrappurtati xi kultant.
If you notice any serious effects or other effects not mentioned in this leaflet,, please inform your veterinary surgeon.
Jekk tinnota xi effetti serji jew effetti oħra mhux imsemmija f’ dan il- fuljett, jekk jogħġbok informa lit - tabib veterinarju tiegħek.
Dosage Initial treatment is a single dose of 0.2 mg meloxicam/ kg body weight on the first day.
Dożaġġ It- trattament tal- bidu tikkonsisti minn doża waħda ta ’ 0. 2 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem fl - ewwel jum.
Dosing procedure using the measuring syringe:
Il- proċedura tad- dożaġġ bl- użu tas- siringa tal- kejl:
Shake bottle w ell.
Ħawwad il- flixkun sew.
Turn the bottle/ syringe
Agħfas ’ l isfel u ħoll it- tapp tal- flixkun.
Attach the dosing syringe to the
Waħħal is- siringa tad- dożaġġ mal- qattara tal - flixkun billi timbotta bil- mod.
plunger out until the black line on the plunger
Aqleb il- flixkun/ is- siringa ta ’ taħt fuq.
syringe onto the food or directly into the m outh.
Iġbed il- planġer ’ il barra sakemm is- sinjal iswed fuq il- planġer ikun jikkorrispondi mal- piż tal - ġisem tal- kelb tiegħek f’ kilogrammi.
drop dispenser of the bottle by gently pushing.
Dawwar il- flixkun lura kif suppost u permezz ta ’ moviment li jilwi, issepara s - siringa tad- dożaġġ minn mal - flixkun.
dosing syringe from the bottle.
Imbotta l- planġer ’ l isfel u battal il- kontenut tas- siringa fuq l- ikel jew direttament ġol - ħalq.
Alternatively therapy may be initiated with Metacam 5 mg/ ml solution for injection.
Alternattivament, it- terapija tista ’ tinbeda b’ 5 mg/ ml soluzzjoni għal injezzjoni ta ’ Metacam.
A clinical response is normally seen within 3 - 4 days.
Rispons kliniku ġeneralment ikun osservat wara 3- 4 ijiem.
9.
100/ 125 9.
Please carefully follow the
Għandha tingħata attenzjoni partikulari fir- rigward ta ’ l- eżattezza tad- dożaġġ.
100/ 125 instructions of the veterinarian.
Jekk jogħġbok segwi bl - attenzjoni l- istruzzjonijiet tal- veterinarju.
Do not use after the expiry date (EXP) stated on the carton and the bottle.
Tużax wara d- data ta ’ l- iskadenza (EXP) fuq il- kartuna u l- flixkun.
Precautions to be taken by the person administering the product People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Prekawzjonijiet li għandhom jittieħdu mill- persuna li tamministra l- prodott 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 parir mediku minnufih u uri l- fuljett tal- pakkett jew it- tikketta lit- tabib.
Use during pregnancy and lactation See section "Contraindications".
Użu fit- tqala u fi żmien il- ħalib Ara sezzjoni `Kontra- indikazzjonijiet´.
Interactions Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects.
Interazzjonijiet NSAIDs oħrajn, dijuretiċi, antikoagulanti, antibijotiċi aminoglikosidi u sustanzi oħra li jeħlu ħafna mal- proteini, jistgħu jikkompetu għat- twaħħil u b’ hekk iwasslu għal effetti tossiċi.
The treatment-free period, however, should take into account the pharmacological properties of the products used previously.
Fil- perjodu mingħajr trattament, madankollu, għandu jkun ikkunsidrat il- karatteristiċi farmakoloġiċi tal- prodotti użati qabel.
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 minnek.
10, 32, 100 or 180 ml bottle.
Flixkun ta ’ 10, 32, 100 jew 180 ml.
102/ 125 PACKAGE LEAFLET FOR:
102/ 125 FULJETT TA ’ TAGĦRIF FIL- PAKKETT:
Marketing authorisation holder Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/ Rhein Germany
Sid l- Awtorizzazzjoni tal- Kummerċ Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/ Rhein Ġermanja
Manufacturer Labiana Life Sciences S. A.
Manifattur Labiana Life Sciences S. A.
Metacam 5 mg/ ml solution for injection for dogs and cats Meloxicam
Meloxicam
In dogs, these side effects occur generally within the first treatment week and are in most
Fil- klieb, dawn l- effetti sekondarji ġeneralment iseħħu fi żmien l- ewwel ġimgħa
103/ 125 cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
103/ 125 tat- trattament, u f’ ħafna każijiet jgħaddu malajr u jisparixxu wara t- tmiem tat- trattament, iżda f’ każijiet rari ħafna, jistgħu jkunu serji jew fatali.
Dosage for each species
Dożaġġ għal kull speċi
Method and routes of administration
Mod ta ’ kif u mnejn jingħata
Do not use after the expiry date (EXP) stated on the carton and the bottle.
104/ 125 Tużax wara d- data ta ’ l- iskadenza (EXP) fuq il- kartuna u l- flixkun.
Precautions to be taken by the person administering the product Accidental self-injection may give rise to pain.
Prekawzjonijiet li għandhom jittieħdu mill- persuna li tamministra l- prodott Injezzjoni aċċidentali tiegħek nnifsek tista ’ tikkaġuna wġigħ.
Interactions Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects.
Interazzjonijiet NSAIDs oħrajn, dijuretiċi, antikoagulanti, antibijotiċi aminoglycoside u sustanzi oħra li jeħlu ħafna mal- proteini, jistgħu jikkompetu għat- twaħħil u b’ hekk iwasslu għal effetti tossiċi.
In animals at anaesthetic risk (e. g. aged animals) intravenous or subcutaneaous fluid therapy during anaesthesia should be taken into consideration.
F’ annimali li jkunu f’ riskju tal- loppju (eż. annimali xjuħ), it- terapija bil- fluwidu ġol- vina jew taħt il- ġilda waqt il- loppju għandha tigi kkunsidrata.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before commencement of treatment.
It- trattament minn qabel b’ sustanzi anti- infjammatorji jista ’ jirriżulta f’ effetti avversi addizzjonali jew miżjuda, u għalhekk għandu jiġi osservat perjodu ta ’ 24 siegħa mingħajr trattament b’ mediċini bħal dawn, qabel ma jibda t- trattament Il- perjodu mingħajr trattament, madankollu, irid jikkunsidra l - karatteristiċi farmakoloġiċi tal - prodotti użati qabel.
The treatment-free period, however, should take into account the pharmacological properties of the products used previously.
Doża eċċessiva F’ każ ta ’ doża eċċessiva, għandu jinbeda trattament sintomatiku.
Overdose In the case of overdosage symptomatic treatment should be initiated.
Biex itaffi l- uġigħ ta ’ wara l- operazzjoni, is- sigurtà kienet dokumentata biss wara loppju b’ thiopental/ halothane.
14.
105/ 125 14.
10 or 20 ml injection vial.
Kunjett ta ’ l- injezzjoni ta ’ 10 jew 20 ml.
Not all pack sizes may be marketed.
Mhux id- daqsijiet kollha tal- pakketti jistgħu jitpoġġew fis - suq.
106/ 125 PACKAGE LEAFLET FOR:
106/ 125 FULJETT TA ’ TAGĦRIF FIL- PAKKETT:
Marketing authorisation holder
Manifattur Sid l- Awtorizzazzjoni tal- Kummerċ
Venus, 26 Can Parellada Industrial 08228 Terrassa Spain
Venus, 26 Can Parellada Industrial 08228 Terrassa
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.
Għall- użu fi żmien ta ’ infezzjoni akuta fis- sistema tan- nifs, flimkien ma ’ terapija antibijotika adattata biex ittaffi s- sintomi kliniċi tal- marda lill- baqar.
For 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.
Għall- użu fit- trattament ta ’ dijarea flimkien ma ’ terapija ta ’ idratazzjoni orali mill- ġdid, biex jitnaqqsu s- sintomi kliniċi f’ għoġġiela li għandhom aktar minn ġimgħa jew frieħ baqar ta ’ età żgħira.
For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.
Għal terapija addizzjonali fit- trattament ta ’ mastite akuta, flimkien ma ’ terapija antibijotika adattata.
107/ 125 Do not use in pregnant or lactating mares.
107/ 125 Tużax fuq debbijiet tqal jew li qed ireddgħu.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Tużax f’ annimali li għandhom indeboliment fil- funzjoni tal- fwied, tal- qalb jew tal- kliewi, u mard emorraġiku, jew fejn ikun hemm evidenza ta ’ leżjonijiet gastrointestinali ulċeroġeniċi Tużax f’ każ ta ’ sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculo- skeletal disorders, Metacam 15 mg/ ml oral suspension may be used for continuation of treatment at a dosage of 0.6 mg meloxicam/ kg body weight, 24 hours after administration of the injection.
Għall- użu sabiex tittaffa l- infjammazzjoni u għas- solliev ta ’ l- uġigħ f’ mard muskolu- skeletriku li jkun kemm akut kif ukoll kroniku, Metacam 15 mg/ ml suspensjoni orali jista ’ jintuża għat- tkomplija tat- trattament f’ dożaġġ ta ’ 0. 6 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem, 24 siegħa wara l- għoti ta ’ l - injezzjoni.
Do not use after the expiry date (EXP) stated on the carton and vial.
Tużax wara d- data ta ’ l- iskadenza (EXP) fuq il- kartuna u l- kunjett.
In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the diagnosis should be made as this could indicate the need for surgical intervention.
F’ każ ta ’ solliev mhux adegwat ta ’ l- uġigħ meta użat fit- trattament ta ’ kolika ekwina, għandha ssir evalwazzjoni mill- ġdid bl- attenzjoni tad- dijanjosi, għax din tista ’ tindika l- ħtieġa ta ’ intervent kirurġiku.
Use during pregnancy and lactation Cattle and pigs:
Użu fit- tqala u fi żmien il- ħalib Baqar u qżieqeż:
See section "Contraindications".
Ara sezzjoni `Kontra- indikazzjonijiet´.
Interactions Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.
Interazzjonijiet M’ għandux jingħata flimkien ma ’ glukokortikosterojdi, sustanzi anti- infjammatorji oħrajn mhux sterojdiċi u jew ma ’ antikoagulanti.
Overdose In the case of overdosage, symptomatic treatment should be initiated.
Doża eċċessiva F’ każ ta ’ doża eċċessiva, għandu jinbeda trattament sintomatiku.
13.
109/ 125 13.
Cardboard box with either 1 or 12 colourless glass injection vial(s) of 20, 50 or 100 ml.
Kaxxa tal- kartun b’ kunjett wieħed jew 12 kunjetti tal- ħġieġ għall- injezzjoni ta’ 20, 50 jew 100 ml, mingħajr kulur.
Cardboard box with either 1 or 6 colourless glass injection vial(s) of 250 ml.
Kaxxa tal- kartun b’ kunjett wieħed jew 6 kunjetti tal- ħġieġ għall- injezzjoni ta’ 250 ml, mingħajr kulur.
110/ 125 PACKAGE LEAFLET FOR:
110/ 125 FULJETT TA ’ TAGĦRIF FIL- PAKKETT:
Isolated cases of adverse reactions typically associated with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) were observed in clinical trials (slight urticaria, diarrhoea).
Każijiet iżolati ta ’ reazzjonijiet avversi li ġeneralment huma assoċjati ma ’ Mediċini Mhux Sterojdi Kontra l- Infjammazzjoni (NSAIDs) kienu osservati fi provi kliniċi (urtikarja ħafifa, dijarea).
Symptoms were reversible.
Is - sintomi kienu riversibbli.
Oral suspension to be administered at a dosage of 0.6 mg/ kg body weight, once daily, up to 14 days.
Suspensjoni orali biex tingħata f’ dożaġġ ta ’ 0. 6 mg / kg ta ’ piż tal- ġisem, darba kuljum, sa 14- il jum.
To be administered either mixed with a small quantity of food, prior to feeding, or directly into the mouth.
Biex jingħata jew imħallat ma ’ kwantità żgħira ta ’ l- ikel, qabel l- għalf, jew direttamemt fil- ħalq.
The suspension should be given using the Metacam measuring syringe provided in the package.
Is- suspensjoni għandha tingħata permezz tas- siringa ta ’ Metacam ipprovduta fil- pakkett.
The syringe fits onto the bottle and has a kg-body weight scale.
Is- siringa teħel fuq il- flixkun u għandha skala ta ’ kilogramm- piż tal- ġisem.
Shelf-life after first opening of the container:
Iż- żmien kemm idum tajjeb il- prodott wara li jinfetaħ il- kontenitur għall- ewwel darba:
Precautions to be taken by the person administering the product People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Prekawzjonijiet li għandhom jittieħdu mill- persuna li tamministra l- prodott Nies li hu magħruf li huma sensittivi għal NSAIDs għandhom jevitaw li jmissu mal- prodott mediċinali veterinarju.
112/ 125 See section "Contraindications".
112/ 125 Użu fit- tqala u fi żmien il- ħalib Ara sezzjoni `Kontra- indikazzjonijiet´.
Interactions Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.
Interazzjonijiet Tagħtix flimkien ma ’ glukokortikosterojdi, sustanzi anti- infjammatorji oħrajn mhux sterojdiċi jew ma ’ antikoagulanti.
100 or 250 ml bottle.
Flixkun ta ’ 100 jew 250 ml.
113/ 125 PACKAGE LEAFLET FOR:
113/ 125 FULJETT TA ’ TAGĦRIF FIL- PAKKETT:
Meloxicam 0.5 mg/ ml (equivalent to 0.02 mg per drop)
Meloxicam 0. 5 mg/ ml (ekwivalenti għal 0. 02 mg kull qatra)
Initial treatment is a single dose of 0.2 mg meloxicam/ kg body weight on the first day.
It- trattament tal- bidu tikkonsisti minn doża waħda ta ’ 0. 2 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem fl - ewwel jum.
15 or 30 ml bottle.
Flixkun ta ’ 15 jew 30 ml.
117/ 125 PACKAGE LEAFLET FOR:
117/ 125 FULJETT TA ’ TAGĦRIF FIL- PAKKETT:
Metacam 1 mg chewable tablets for dogs Metacam 2.5 mg chewable tablets for dogs Meloxicam
Metacam 1 mg pilloli li tomgħodhom għall- klieb Metacam 2. 5 mg pilloli li tomgħodhom għall- klieb Meloxicam
Honey flavoured, pale-yellow, single-scored, oval chewable tablets with embedded code M01 (1 mg) and M02 (2.5 mg) on one side of the tablet.
Pilloli li tomgħodhom b’ togħma ta ’ l- għasel, ta ’ lewn isfar ċar, b’ linja waħda, ovali, bil- kodiċi M01 (1 mg) u M02 (2. 5 mg) imnaqqxa fuq naħa waħda tal- pillola.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Jekk tinnota xi effetti serji jew effetti oħrajn li mhumiex imsemmija f’ dan il- fuljett, jekk jogħġbok informa lill- kirurgu veterinarju tiegħek.
Dose scheme for the maintenance dose:
Numru ta ’ pilloli li tista ’
mg/ kg
0. 13 0. 14
4.0 – 7.0 7.1 – 10.0 10.1– 15.0 15.1 – 20.0 20.1 – 25.0 25.1 – 35.0 35.1 – 50.0
10. 1 – 15. 0 15. 1 – 20. 0 20. 1 – 25. 0 25. 1 – 35. 0 35. 1 – 50. 0
½ 1 1½ 2 1 1½ 2
1½ 2
The use of Metacam
1 1½ 2
oral suspension for dogs may be
0. 15 – 0. 1 0. 13 – 0. 1 0. 12 – 0. 1 0. 15 – 0. 1 0. 14 – 0. 1
For
L- użu ta ’ Metacam suspensjoni orali għall- klieb tista ’ tkun ikkunsidrata għal dożaġġ li jkun iktar preċiż.
dogs weighing less than 4 kg the use of Metacam oral suspension for dogs is recommended.
Għall- klieb li jiżnu inqas minn 4 kg, l- użu ta ’ Metacam suspensjoni orali għall- klieb hi rakkomandata.
Instructions for opening the child-resistant blisters:
Struzzjonijiet biex tiftaħ il- folji reżistenti għat- tfal: