qanastek/EMEA-V3 huggingface dataset:
For active immunisation of pigs over the age of 2 weeks against Porcine Circovirus Type 2 (PCV2).
Għal tilqima attiva ta ’ qżieqeż fuq l- età ta ’ ġimagħtejn kontra Circovirus tal- Qżieqeż ta ’ Tip 2 (PCV2).
Single intramuscular injection of one dose (1 ml) Read the package leaflet before use.
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett.
EXP {month/ year} Use immediately after opening.
EXP {xahar/ sena} Uża immedjatament wara li tiftħu.
Store and transport refrigerated (2 °C - 8 °C).
Aħżen u ttrasporta ġo friġġ (2°C - 8°C).
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA ’ PRODOTTI MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM "GĦAL TRATTAMENT TA ’ L- ANNIMALI BISS ” U KUNDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVVISTA U L- UŻU, jekk applikabbli
For animal treatment only - to be supplied only on veterinary prescription.
Għal trattament ta ’ l- annimali biss - għandu jingħata biss bi preskrizzjoni veterinarja.
11 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
11 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
{100 ml, 250 ml bottle}
{100 ml, 250 ml flixkun}
100 ml (100 doses) 250 ml (250 doses)
100 ml (100 doża) 250 ml (250 doża)
Single intramuscular injection of one dose (1 ml).
Injezzjoni waħda ġol- muskoli ta ’ doża waħda (1 ml).
SPECIAL WARNINGS, IF NECESSARY
TWISSIJA/ IET SPEĊJALI OĦRA, JEKK MEĦTIEĠA
Boehringer Ingelheim Vetmedica GmbH Germany
Boehringer Ingelheim Vetmedica GmbH Il- Ġermanja
13 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
13 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
{10 ml, 50 ml bottle}
{10 ml, 50 ml flixkun}
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
KONTENUT BĦALA PIŻ, VOLUM JEW NUMRU TA ’ DOŻI
10 ml (10 doses) 50 ml (50 doses)
10 ml (10 dożi) 50 ml (50 doża)
EXP {month/ year} Use immediately after opening.
EXP {xahar/ sena} Ġaladarba jinfetaħ, uża immedjatament (fi żmien 4 sigħat).
15 PACKAGE LEAFLET FOR:
15 FULJETT TA ’ TAGĦRIF FIL- PAKKETT
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
Adjuvant:
Kull doża ta ’ 1 ml ta ’ tilqima diżattivata fiha: circovirus tal- qżieqeż ta ’ tip 2 ORF2 proteina: minimu RP * 1. 0, massimu RP * 3. 75 * Potenza Relattiva (test ELISA) permezz ta ’ paragun ma ’ tilqima ta ’ referenza Sustanza mhux attiva:
For active immunisation of pigs over the age of 2 weeks against Porcine Circovirus Type 2 (PCV2) to reduce mortality, clinical signs - including weight loss - and lesions of in lymphoid tissues associated with PCV2 related diseases (PCVD).
Għal tilqima attiva ta ’ qżieqeż fuq l- età ta ’ ġimagħtejn kontra Circovirus tal- Qżieqeż ta ’ Tip 2 (PCV2) biex titnaqqas il- mortalità, sinjali kliniċi - li jinkludu telf ta ’ piż – u leżjonijiet f’ tessuti limfodje assoċjati ma ’ mard marbut ma ’ PCV2 (PCVD).
In addition, vaccination has been shown to reduce PCV2 nasal shedding, viral load in blood and lymphoid tissues, and duration of viraemia.
Flimkien ma ’ dan, intwera li t- tilqima tnaqqas twaqqigħ nażali PCV2, it- tagħbija virali fid- demm u fit - tessuti limfodje, u t- tul ta ’ żmien kemm iddum il- viraemia.
Duration of immunity:
Il- bidu ta ’ l- immunità: iseħħ minn kmieni sa minn ġimagħtejn wara t- tilqima Kemm iddum l- immunità: mill- inqas 17- il ġimgħa.
Single intramuscular(IM) injection of one dose (1 ml) to pigs, irrespective of body weight.
Injezzjoni waħda ġol- muskoli (IM) ta ’ doża waħda (1 ml) lill- qżieqeż, irrispettivament mill- piż tal - ġisem.
Use vaccination devices according to the manufacturer's instructions.
Użu t- tagħmir tat- tilqim skond l- istruzzjonijiet tal- manifattur.
Avoid multiple vial broaching.
Evita titqib multiplu tal- kunjett.
Store and transport refrigerated (2 °C - 8 °C).
Aħżen u ttrasporta fil- friġġ (2°C - 8°C).
Do not use after the expiry date (EXP) which is stated on the carton and the bottle.
Tużax wara d- data ta ’ l- iskadenza (EXP) li hemm fuq il- kartuna u l- flixkun.
Precautions for use in animals Avoid introduction of contamination during use.
Prekawzjonijiet speċjali għall- użu fl- annimali Evita li tintroduċi xi kontaminazzjoni waqt l- użu.
Use during pregnancy and lactation Do not use during pregnancy and lactation.
Użu fit- tqala u fi żmien il- ħalib Tużahx fit- tqala u fi żmien il- ħalib.
Incompatibilities No safety or efficacy information is available on the compatibility of this vaccine with any other vaccine.
Inkompatibilitajiet L- ebda informazzjoni dwar is- sigurtà jew l- effikaċja ta ’ din it- tilqima ma ’ xi tilqima oħra mhi disponibbli.
It is therefore recommended that no other vaccines should be administered on the same day or at different times.
Għalhekk hu rakkomandat li ma jingħata l- ebda tilqim ieħor, la fl- istess jum u lanqas f’ xi ħin ieħor.
Do not mix with any other vaccine or immunological product.
Tħallatx ma ’ tilqim jew prodotti immunoloġiċi oħra.
Waste materials should be disposed of in accordance with local requirements.
Il- materjal għar- rimi għandu jintrema kif jitolbu l- liġijiet lokali.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /.
Bottle of 10 ml (10 doses), 50 ml (50 doses), 100 ml (100 doses), or 250 ml (250 doses) packed individually in a cardboard box.
Flixkun ta ’ 10 ml (10 dożi), 50 ml (50 doża), 100 ml (100 doża), jew 250 ml (250 doża) ippakkjati individwalment f’ kaxxa tal- kartun.
What is Locatim?
X’ inhu Locatim?
Locatim is an oral solution produced from colostrum which is given to calves in the first 12 hours of life.
Locatim hu soluzzjoni orali prodotta mill- kolostru li tingħata lill- għoġġiela fl- ewwel 12- il siegħa mit- twelid.
It contains specific immunoglobulins G (a type of antibody) against Escherichia coli F5 adhesin as its active substance.
Fih l- immunoglobulini G (tip ta ’ antikorpi) speċifiċi għal kontra l - Escherichia coli F5 adhesin li huma s- sustanza attiva tiegħu.
These immunoglobulins protect calves against disease caused by bacteria.
Dawn l- immunoglobulini jipproteġu lill- għoġġiela kontra l- mard ikkawżat minn batterji.
Locatim is presented in a 60 ml glass bottle.
Locatim jiġi fi flixkun tal- ħġieġ ta ’ 60 ml.
What is Locatim used for?
Għalxiex jintuża Locatim?
Locatim is used to reduce death in newborn calves caused by enterotoxicosis due to the bacterium E. coli during the first days of life.
Locatim jintuża biex inaqqas l- imwiet fl- għoġġiela tat- twelid ikkawżati minn enterotossikożi minħabba l- batterju E. coli waqt l- ewwel ftit jiem mit- twelid.
Enterotoxicosis is a disease caused by the release of toxins in the body, with the main symptom being diarrhoea.
L- enterotossikożi hi marda kkawżata mir- rilaxx ta ’ tossini fil- ġisem, bis- sintomu ewlieni jkun id- dijarea.
Locatim is given to calves less than 12 hours old, preferably within the first four hours after birth, as a supplement to natural colostrum (first milk) that the calves receive from their mother.
Locatim jingħata lill- għoġġiela ta ’ inqas minn 12- il siegħa, preferibbilment fl- ewwel erba ’ sigħat mit- twelid, bħala suppliment għall- kolostru (ħalib tal- bidu) naturali li l- għoġġiela jieħdu mingħand ommhom.
The dose of 60 ml (one vial) may be given alone or dissolved in milk or milk substitute.
Id- doża ta ’ 60 ml (fjala waħda) tista ’ tingħata waħedha jew imħallta fil- ħalib jew f’ sostitut tal- ħalib.
How does Locatim work?
Kif jaħdem Locatim?
Locatim works by supplementing the protective properties of normal colostrum, the first milk made by cows after giving birth, which their calves drink during the first few hours of life.
Locatim jaħdem bis- supplimentazzjoni tal- karatteristiċi protettivi tal- kolostru normali, l- ewwel ħalib magħmul mill- baqar wara li jwelldu, li l- għoġġiela tagħhom jixorbu fl- ewwel ftit sigħat wara t- twelid.
Colostrum contains antibodies that help to protect the calves against certain infections.
Il- kolostru jkun fih antikorpi li jgħinu biex jipproteġu lill- għoġġiela minn ċerti infezzjonijiet.
Locatim is made from colostrum from cows that have been immunised against E. coli, so that they produce antibodies in their colostrum.
Locatim jiġi magħmul mill- kolostru minn baqar li jkunu tlaqqmu kontra l- E. coli, biex jipproduċu antikorpi fil- kolostru tagħhom.
The colostrum is collected and filtered and the lactoserum (the whey, the liquid part of milk) is concentrated to make Locatim.
Il- kolostru jinġabar u jissaffa u l- laktoseru (ix - xorrox, il- parti likwida tal- ħalib) jiġi konċentrat biex isir Locatim.
By providing additional antibodies against E. coli, calves receiving Locatim gain additional protection against this bacterium.
Bl- għoti ta ’ iktar antikorpi kontra l- E. coli, l- għoġġiela li jingħataw Locatim jiksbu protezzjoni addizzjonali kontra dan il - batterju.
The natural uptake of colostrum within the first hours of life induces passive immunisation.
It- teħid naturali tal- kolostru fl- ewwel ftit sigħat tal- ħajja jwassal għal immunità passiva.
Locatim thereby provides additional protection against deaths due to enterotoxicosis caused by E. coli.
Locatim b’ hekk jipprovdi protezzjoni addizzjonali għal kontra l- imwiet ikkawżati mill - enterotossikożi kkawżata mill- E. coli.
(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 benefit has Locatim shown during the studies?
(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 Kif ġie studjat Locatim?
In the laboratory-based study, calves receiving Locatim had less severe clinical signs of diarrhoea and better survival time than those that did not receive it.
Fl- istudju bbażat fil- laboratorju, l- għoġġiela li ngħataw Locatim kellhom sinjali inqas severi ta ’ dijarea u ħin ta ’ sopravivenza aħjar minn dawk li qatt ma rċevewh.
These results were confirmed in a field-based study.
Dawn ir- riżultati ġew ikkonfermati fl- istudju bbażat fil- post fejn jgħixu l- annimali.
What is the risk associated with Locatim?
X’ inhu r- riskju assoċjat ma ’ Locatim?
There are no major side effects with Locatim.
Ma hemm l- ebda effett sekondarju maġġuri ma ’ Locatim.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
X’ inhuma l- prekawzjonijiet għall- persuna li tagħti l- mediċina jew li tiġi f’ kuntatt ma ’ l - annimal?
There are no special precautions for Locatim.
Ma hemm l- ebda prekawzjoni speċjali għal Locatim.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Kemm irid jgħaddi ħin qabel ma l- annimal ikun jista ’ jinqatel u l- laħam tiegħu jintuża għall - konsum mill- bniedem (withdrawal period)?
The withdrawal period is zero days.
Il- perjodu ta ’ restrizzjoni huwa ta ’ żero jiem.
Why has Locatim been approved?
Għaliex ġie approvat Locatim?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Locatim exceed the risks for the treatment of calves less than 12 hours of age to reduce mortality caused by enterotoxicosis associated with E. coli F5 (K99) adhesin during the first days of life as a supplement to colostrum from the dam, and recommended that Locatim be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Locatim jisbqu r- riskji tiegħu għat- trattament ta ’ għoġġiela ta ’ inqas minn 12- il siegħa mit - twelid biex iwassal għal tnaqqis fil- mortalità kkawżata mill- enterotossikożi assoċjata ma ’ l - E. coli F5 (K99) adhesin waqt l- ewwel jiem tal- ħajja bħala suppliment għall- kolostru, u rrakkomanda li Locatim jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ bejn il - benefiċċju u r- riskju jinstab fil- modulu 6 ta ’ dan l- EPAR.
Other information about Locatim:
Tagħrif ieħor dwar Locatim:
The European Commission granted a marketing authorisation valid throughout the European Union for Serinucoli to Biokema Anstalt on 29 March 1999.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Serinucoli lil Biokema Anstalt fid- 29 ta ’ Marzu 1999.
The name of the medicine was changed to Locatim on 14 September 1999.
L- isem tal- mediċina inbidel għal Locatim fl- 14 ta ’ Settembru 1999.
The marketing authorisation was renewed on 29 March 2004.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fid- 29 ta ’ Marzu 2004.
Invented Strength name
Isem kummerċjali
Pharmaceutical Target species Form
Qawwa
Packaging
Speċi li fuqhom għandu jintuża l - prodott
Content
Mod ta ’ Amministrazzjoni
Package size
Ippakkjar Kontenut
Withdrawal period
Daqs tal - Perjodu ta ’ pakkett Tiżmim
> 2.8log10 / ml bovine Oral solution concentrated lactoserum
> 2. 8log10 / ml Konċentrat tal - lattoserum tal - bovini
Neonatal calves less than 12 hours of age
Soluzzjoni orali
Oral use
Għoġġiela li għadhom Li tittiehed mill - jitwieldu li għandhom ħalq anqas minn 12- il siegħa
Type III glass 60 ml bottles
flixkun ta ’ 60 ml ħġieġ tipp III
1 bottle
1 Flixkun Xejn
Locatim, oral solution for neonatal calves less than 12 hours of age
Locatim soluzzjoni orali għal għoġġiela tat- twelid li għandhom anqas minn 12- il siegħa
Active substance
Sustanza( i) Attiva( i):
Bovine concentrated lactoserum containing specific Immunoglobulins G against E. coli F5 (K99) adhesin ≥ 2.8* log10/ ml. * microagglutination method
Konċentrat tal- lattoserum ta ’ l- ifrat li fih Immunoglobilini G li jaġixxu kontra E. coli F5 (K99) adhesin ≥ 2. 8 * log10/ ml * Bil metodu ta ’ mikro- agglutinazzjoni
Excipient(s)
Ingredjenti ohra:
Methyl parahydroxybenzoate ≤ 0.8 mg/ ml Propyl parahydroxybenzoate ≤ 0.2 mg/ ml
Methyl parahydroxybenzoate ≤ 0. 8 mg/ ml Propyl parahydroxybenzoate ≤ 0. 2 mg/ m
Neonatal calves less than 12 hours of age
Għoġġiela li għadhom jitwieldu li għandhom anqas minn 12- il siegħa.
Reduction of mortality caused by enterotoxicosis associated with E. coli F5 (K99) adhesin during the first days of life as a supplement to colostrum from the dam.
Tnaqqis fil- mortalità ikkaġunata minn enterotossikożi assoċjata ma ’ E. coli F5 (K99) adhesin matul l - ewwel jiem ta ’ hajja bħala suppliment għal kolostrum mingħand il- baqra.
The product is produced from colostrum collected from cows kept under field conditions.
Il- prodott jiġi magħmul minn kolostrum miġbur mill- baqar miżmuma taħt kundizzjonijiet idejali.
Consequently, in addition to antibodies to E. coli F5 (K99) it also contains antibodies to other organisms, as a result of vaccination and/ or exposure of the donor cows to organisms in their environment.
Sussegwentement, barra anti- korpi għal vaċċinazzjoni għal E. Coli F5 (K99) huwa fih ukoll anti- korpi għal organiżmi oħra, bħala riżultat ta ’ vaċċinazzjoni u/ jew espożizzjoni tal- baqar donaturi għal organiżmi fl- ambjent tagħhom.
This should be borne in mind when planning vaccination programmes for calves, which receive Locatim.
Għalhekk wieħed irid ikun konxju dwar dan meta jiġu ppjanati programmi ta ’ vaċċinazzjoni għal għoġol li jieħdu Locatim.
This product may contain antibodies against BVD virus.
Dan il- prodott jista ’ jkun fih anti- korpi kontra l- vajrus ta ’ BVD.
None.
Mhux Applikabbli.
4.7 Use during pregnancy or lactation
4. 7 Użu fit- tqala u fi żmien il- ħalib
The product is not intended for use during pregnancy and lactation.
L- użu tiegħu mhux rakkomandat waqt it- tqala jew fi żmien il- ħalib.
No information is available on the safety and efficacy of this product when used with any other veterinary medicinal product.
Ma hemm ebda tagħrif disponibbli dwar is- sigurtau l- effikaċja ta ’ dan il- prodott meta jiġi użat fl- istess ħin ma ’ xi prodott immunoloġiku ieħor.
A decision to use this product on the same day or at different times with any other veterinary medicinal product therefore needs to be made on a case by case basis.
Għalhekk id- deċiżjoni sabiex jintuża dan il- prodott dakinhar stess jew f’ xi drabi oħra ma ’ xi prodott mediċinali veterinarju ieħor għandha tittieħed skont kull każ partikolari.
Oral administration of 60 ml as soon as possible, preferably given within the first 4 hours, but not later than 12 hours after birth.
Teħid mill- ħalq ta ’ 60 ml kemm jista ’ jkun malajr, preferibbilment mogħtija fl- ewwel 4 siegħat, imma mhux aktar minn 12- il siegħa wara t- twelid.
The product should be administered neat or diluted in milk or in milk replacer within the first 12 hours of the calf’ s life, preferably, as soon as it is receptive.
Il- prodott għandu jingħata kif inhu jew dilwit fil- ħalib jew f' dak li jingħata minflok il- ħalib fl- ewwel 12- il siegħa ta ’ ħajjet l- għoġol, kemm jista ’ jkun malajr wara li tibda tirrispondi.
If the calf is reluctant to take the product, it may be administered via an ordinary syringe placed in the mouth.
Jekk l- għoġol isibha bi tqila biex jieħu l- prodott, għandu jingħata permezz ta ’ siringa ordinarja mpoġġija fil- ħalq.
In the absence of information specifically demonstrating the safety of more than one repeated dose, it is recommended that calves should only be dosed once.
L- għoġol għandu jingħata kolostrum normali ieħor barra il- prodott Fin- nuqqas ta ’ informazzjoni li juri b’ mod speċifiku s- sigurtà ta ’ aktar minn doża ripetuta, huwa rrakkomandat li l- għoġol għandhom jingħataw doża waħda biss
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emergenza, antidoti) jekk ikun hemm bżonn
Transient effects of temperature increase and respiration rate increase have been seen when the product is administered in a double dose.
Effetti għaddiena ta ’ żjieda fit- temperatura u żjieda fir- rata ta ’ respirazzjoni intwerew meta l- prodott ġie mogħti f’ doża doppja.
IMMUNOLOGICAL PROPERTIES
KWALITAJIET IMMUNOLOGICI
The product supplements the protective properties of normal colostrum against E. coli F5 (K99) adhesin.
Il- prodott jissuplimenta l- proprjetajiet protettivi ta ’ kolostrum kontra E. coli F5 (K99) adhesin.
ATC vet code:
Kodici ATC veterinarja:
3/ 17 6.2 Incompatibilities
3/ 17 6. 2 Inkompatibilitajiet
In the absence of incompatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Fin- nuqqas ta ’ studji dwar kompattibilita, dan il- prodott mediċinali veterinarju ma jistax jintuża flimkien ma prodotti mediċinali veterinarji oħra.
Keep the container in the outer carton.
Żomm il- flixkun fil- pakkett ta ’ barra.
Cardboard box with one 60 ml type III glass bottle closed with a polypropylene stopper with a polyethylene seal and a detachable lock-ring.
Kaxxa tal- kartun li fiha flixkun wieħed ta ’ 60 ml ta ’ ħġieġ tipp III magħluq b ’ għatu ta ’ polypropylene b’ siġġill tal- polyethylene u b’ annell li jinqalgħa
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użati jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Mediċina veterinarja li ma ġietx użata jew prodotti oħra li ntużaw għal din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiz.
Biokema Anstalt, Pflugstrasse 12, 9490 Vaduz, Fürstentum Liechtenstein
Biokema Anstalt Pflugstrasse 12, 9490 Vaduz Fűrstentum, Liechtenstein
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu.
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /
Any person intending to
L- importazzjoni, bejgħ, provvista u / jew l- użu ta ’ Locatim huwa pprojbit jew jista jkun ipprojbit f' ċertu Stati Membri jew ġo parti mit- Territorju taghhom minhabba l- politika nazzjonali taghhom dwar
4/ 17 import, sell, supply and/ or use Locatim must consult the relevant Member State’ s competent authority on the current animal health policies prior to the import, sale, supply and/ or use.
Kull persuna li turi l- intenzjoni li timporta, tbiegħ tipprovdi u/ jew tuża Locatim għandu jikkonsulta ma ’ l- Awtorità Kompetenti ta ’ l- Istat Membru dwar il- programmi ta ’ tilqim kurrenti qabel timporta, tbiegħ, tipprovdi u/ jew tuża.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTURA( I) TAS- SUSTANZA( I) BIOLOĠIKA( CI) ATTIVA( I) U SID (/ S- SIDIEN TA ’) L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
Name and address of the manufacturer(s) of the biological active substance(s)
Isem u indirizz tal- manifattur tas- sustanza( i) bioloġika( ċi) attiva( i)
Biokema SA Chemin de la Chatanérie 2 1023 Crissier-Lausanne Switzerland
Biokema SA Chemin de la Chatanérie 2 Ch- 1023 Crissier- Lausanne Svizzera
Merial Laboratoire Porte des Alpes Rue de l’ aviation 69800 Saint Priest France
Merial Laboratoire Porte des Alpes Rue de l’ Aviation 69800 Saint Priest Franza
To be supplied only on veterinary prescription.
Sabiex jiġu mogħtija biss bi preskrizzjoni veterinarja. >
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
b) il- marda li għaliha l- prodott mediċinali veterinarju huwa intiż li jagħti immunità hija ġeneralment assenti mit- territorju
Active substance specific immunoglobulins: not applicable
Immunoglobulini speċifiċi għas- sustanza attiva: ma tapplikax hawnhekk
The following excipients are included in Annex II of Council Regulation (EEC) No 2377/ 90 in accordance with the following table:
L- eċċipjenti li ġejjin huma inklużi fl- Anness II tar- Regolament tal- Kunsill (KE) Nru 2377/ 90 skond it - tabella li ġejja
7/ 17 Pharmacologically active substance Calcium chloride1 Sodium chloride 2 Lactic acid 3 Sodium hydroxide 4 Sodium methyl hydroxybenzoate 5 Sodium propyl hydroxybenzoate 6 Sodium propionate 7 Propionic acid8
Kloru tal- kalċju1 Kloru tas- sodju 2 Aċidu lattiku 3 Idrossidu tas- sodju 4 Sodium methyl hydroxybenzoate 5 Sodium propyl hydroxybenzoate 6 Propjonat tas- sodju 7 Aċidu propjoniku8
Animal 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 All food-producing species All food- producing species
Kull speċi li tintuża għall- ikel Kull speċi li tintuża għall- ikel Kull speċi li tintuża għall- ikel Kull speċi li tintuża għall- ikel Kull speċi li tintuża għall- ikel Kull speċi li tintuża għall- ikel Kull speċi li tintuża għall- ikel Kull speċi li tintuża għall- ikel
10/ 17 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10/ 17 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Locatim oral solution for neonatal calves less than 12 hours of age
Locatim soluzzjoni orali għal għoġġiela tat- twelid li għandhom anqas minn 12- il siegħa
Bovine concentrated lactoserum containing specific Immunoglobulins G against E. coli F5 (K99) adhesin ≥ 2.8 log10/ ml.
Konċentrat tal- lattoserum ta ’ l- għoġġiela li fih Immunoglobilini G li jaġixxu kontra E. coli F5 (K99) adhesin ≥ 2. 8 * log10/ ml
TARGET SPECIES
SPEĊI GHAL X' HIEX HUWA INDIKAT IL- PRODOTT
Read the package leaflet before use.
Aqra l- fuljett ta 'tagħrif fil- pakkett qabel tuża
Store in a refrigerator.
Aħżen fil- friġġ (2°C – 8°C)..
Keep the bottle in the outer carton.
Żomm il- flixkun fil- pakkett ta ’ barra.
For animal treatment only - to be supplied only on veterinary prescription.
Għat- trattament ta ’ l- Annimali Biss - għandu jingħata biss bi preskrizzjoni medika.
Keep out of the reach and sight of children.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal zghar.
Biokema Anstalt, Pflugstrasse 12, 9490 Vaduz, Fürstentum Liechtenstein
Biokema Anstalt Pflugstrasse 12 9490 Vaduz Fűrstentum, Liechtenstein
12/ 17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
12/ 17 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
Bovine concentrated lactoserum containing specific Immunoglobulin G against E. coli F5(K99) adhesion > 2.8 log 10/ ml
Konċentrat tal- lattoserum ta ’ l- ifrat li fih Immunoglobilini G li jaġixxu kontra E. coli F5 (K99) adhesin ≥ 2. 8 log10/ ml
Oral administration of 60ml as soon as possible, preferably given within the first 4 hours, but not later than 12 hours after birth.
Teħid mill- ħalq ta ’ 60 ml kemm jista ’ jkun malajr, preferibbilment mogħtija fl- ewwel 4 siegħat, imma mhux aktar minn 12- il siegħa wara t- twelid.
Withdrawal period: zero days
Xejn.
THE WORDS “ FOR ANIMAL TREATMENT ONLY”
IL- KLIEM "GĦAT- TRATTAMENT TA ’ L- ANNIMALI BISS ”
14/ 17 PACKAGE LEAFLET FOR:
14/ 17 FULJETT TA ’ TAGĦRIF FIL- PAKKETT
Merial Laboratoire Porte des Alpes Rue de l’ aviation 69800 Saint Priest France
Merial Laboratoire Porte des Alpes Rue de l’ aviation 69800 Saint Priest Franza
Bovine concentrated lactoserum containing specific Immunoglobulins G against E. coli F5 (K99) adhesin ≥ 2.8* log10/ ml. * microagglutination method
Konċentrat tal- lattoserum ta ’ l- ifrat li fih Immunoglobilini G li jaġixxu kontra E. coli F5 (K99) adhesin ≥ 2. 8 * log10/ ml * Bil- metodu ta ’ mikro- agglutinazzjoni
Methyl parahydroxybenzoate ≤ 0.8 mg/ ml Propyl parahydroxybenzoate ≤ 0.2 mg/ ml
Methyl parahydroxybenzoate ≤ 0. 8 mg/ ml Propyl parahydroxybenzoate ≤ 0. 2 mg/ ml
Reduction of mortality caused by enterotoxicosis associated with E. coli F5 (K99) adhesin during the first days of life as a supplement to colostrum from the dam,
Tnaqqis fil- mortalità ikkaġunata minn enterotossikożi assoċjata ma ’ E. coli F5 (K99) adhesin matul l - ewwel jiem ta ’ hajja bħala suppliment għal kolostrum mingħand il- baqra.
Neonatal calves less than 12 hours of age.
Għoġġiela li għadhom jitwieldu li għandhom anqas minn 12- il siegħa.
The product should be administered neat or diluted in milk or in milk replacer within the first 12 hours of the calf’ s life, preferably, as soon as it is receptive.
Il- prodott għandu jingħata kif inhu jew dilwit fil- ħalib jew f' dak li jingħata minflok il- ħalib fl- ewwel 12- il siegħa ta ’ ħajjet l- għoġol, kemm jista ’ jkun malajr wara li jibda jirrispondi.
The calf must be given other normal colostrum in addition to the product.
L- għoġol għandu jingħata kolostrum normali ieħor minbarra l- prodott.
In the absence of information specifically demonstrating the safety of more than one repeated dose, it is recommended that calves should only be dosed once.
Fin- nuqqas ta ’ informazzjoni li turi b’ mod speċifiku l- ħarsien tas- saħħa ta ’ aktar minn doża ripetuta, huwa rrakkomandat li l- għoġġiela jingħataw doża waħda biss
Store in a refrigerator (2 °C - 8 °C) Keep the bottle in the outer carton.
Aħżen fil- friġġ (2°C – 8°C).
Do not freeze.
Żomm il- flixkun fil- pakkett ta ’ barra.
Do not use after the expiry date stated on the label.
Tużax wara d- data ta’ l- iskadenza fuq it- tikketta.
This product may contain antibodies against BVD virus.
Dan il- prodott jista ’ jkun fih anti- korpi diretti kontra l- virus tal - BVD.
The product is not intended for use during pregnancy and lactation.
Dan il- prodott mhux maħsub biex jintuża waqt it- tqala u t- treddiegħ.
The product is produced from colostrum collected from cows kept under field conditions.
Il- prodott jiġi magħmul minn kolostrum miġbur mill- baqar miżmuma taħt kundizzjonijiet fil- beraħ.
Consequently, in addition to antibodies to E. coli F5 (K99) it also contains antibodies to other organisms, as a result of vaccination and/ or exposure of the donor cows to organisms in their environment.
Sussegwentement, barra anti- korpi għal vaċċinazzjoni għal E. Coli F5 (K99) huwa fih ukoll anti- korpi għal organiżmi oħra, bħala riżultat ta ’ vaċċinazzjoni u/ jew espożizzjoni tal- baqar li minnhom jittieħed il- kolostrum, għal organiżmi fl- ambjent tagħhom.
This should be borne in mind when planning vaccination programmes for calves, which receive Locatim.
Għalhekk wieħed irid ikun konxju dwar dan meta jiġu ppjanati programmi ta ’ vaċċinazzjoni għal għoġol li jieħdu Locatim
Transient effects of temperature increase and respiration rate increase have been seen when the product is administered in a double dose.
Effetti li jgħaddu ta ’ żjieda fit- temperatura u żjieda fir- rata ta ’ respirazzjoni intwerew meta l- prodott ġie mogħti f’ doża doppja.
No information is available on the safety and efficacy of this product when used with any other veterinary medicinal product.
Ma hemm ebda tagħrif disponibbli dwar is- sigurta u l- effikaċja ta ’ dan il- prodott meta jiġi użat ma ’ xi prodott mediċinali veterinarju ieħor.
The import, sale, supply and/ or use of Locatim is or may be prohibited in certain Member States on the whole or part of their territory pursuant to National animal health policy.
L- importazzjoni, bejgħ, provvista u / jew l- użu ta ’ Locatim huwa pprojbit jew jista jkun ipprojbit f' ċertu Stati Membri jew ġo parti mit - _ Territorju taghhom minhabba l- politika nazzjonali taghhom
16/ 17 13.
16/ 17 dwar is- sahha ta ’ l- annimali.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR RIMI TA 'PRODOTT MHUX UŻATA JEW MATERJAL IEĦOR GĦAR- RIMI
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Mediċina veterinarja li ma ġietx użata jew prodotti oħra li ntużaw ghal din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
60 ml bottle.
Daqs tal- kontenitur: flixkun ta ’ 60 ml
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Għal kull tagħrif dwar dan il- prodott mediċinali veterinarju, jekk jogħġbok ikkuntattja lir - rappreżentant lokali tas- sid tal- awtorizzazzjoni tal- kummerċ
What is Loxicom?
X’ inhu Loxicom?
Loxicom is presented as a pale yellow oral suspension which is to be given mixed with food or directly into the mouth for dogs, or as a pale yellow solution for injection for use in dogs or cats.
Loxicom huwa sospensjoni orali ta ’ kulur safrani li għandu jingħata mħallat mal- ikel jew direttament f’ ħalq il- klieb, jew bħala soluzzjoni ta ’ kulur safrani għal injezzjoni għall- użu fi klieb jew qtates.
Loxicom contains the active substance meloxicam in a strength of 0.5 mg/ ml or 1.5 mg/ ml for the oral suspension, and a strength of 5 mg/ ml for the solution for injection.
Loxicom fih sustanza attiva meloxicam u jeżisti f’ żewġ qawwiet 0. 5 u 1. 5mg/ ml rispettivament għal sospensjoni orali u f’ qawwa ta ’ 5mg/ ml għal soluzzjoni għal injezzjoni.
Loxicom is a ‘ generic ’ which means that Loxicom is similar to a ‘ reference veterinary medicine ’ already authorised in the EU (Metacam 1.5 mg/ ml oral suspension).
Loxicom huwa ‘ ġeneriku ’ li jfisser li Loxicom 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 Loxicom is ‘ bioequivalent ’ to the reference veterinary medicine which means that Loxicom is equivalent to Metacam 1.5 mg/ ml suspension in the way it is absorbed and used by the body.
Saru studji sabiex jipprovaw li Loxicom huwa ‘ bijoekwivalenti ’ għal mediċina veterinarja ta ’ referenza li tfisser li Loxicom huwa ekwivalenti għal Metacam 1. 5 mg/ ml sospensjoni bil- mod li huwa assorbit u użat mill- ġisem.
What is Loxicom used for?
Għal xiex jintuża Loxicom?
Loxicom is used in dogs to relieve inflammation and pain in musculo-skeletal disorders.
Loxicom jintuża fil- klieb sabiex titnaqqas l- infjammazzjoni u l- uġigħ fil- problemi muskuloskeletriku.
It can be used for both acute disorders, such as those seen after an injury, and chronic (long term) disorders.
Jista ’ jintuża kemm biex jikkura problema akuti, bħal dawk li jidhru wara li pazjent ikun weġġa ’, u problemi kroniċi (fit- tul).
The solution for injection form is also used in dogs to reduce post-operative pain and inflammation following orthopaedic and soft tissue surgery or in cats to reduce post-operative pain after ovariohysterectomy (spaying) and minor soft tissue surgery.
Is- soluzzjoni f’ forma ta ’ injezzjoni hija użata wkoll fi klieb sabiex jitnaqqas l- uġigħ postoperatorju u l- infjammazzjoni ortopedika u kirurġija tat- tessut artab jew fi qtates sabiex jitnaqqas l- uġigħ postoperatorju wara li ssir operazzjoni tat- tneħħija tal- ovarji u tal- utru (tiswija) u kirurġija minuri tat- tessut artab.
How does Loxicom work?
Kif jaħdem Loxicom?
Loxicom contains meloxicam, which belongs to a class of medicines called non-steroidal anti- inflammatory drugs (NSAIDs).
Loxicom fih meloxicam li jappartjeni għall- klassi ta ’ mediċini msejħa mediċini anti- infjammatorji mhux sterojdi (NSAIDs).
Meloxicam acts by inhibition of prostaglandin synthesis.
Meloxicam jaġixxi billi jinibixxi s- sintesi tal- prostaglandini.
As the prostaglandins are substances that trigger inflammation, pain, exudation and fever, meloxicam reduces those responses.
Minħabba li l - prostaglandini huma sustanzi li jikkawżaw l- infjammazzjoni, l- uġigħ, il- ħruġ ta 'għaraq u d- deni, meloxicam inaqqas dawn ir- reazzjonijiet.
Reproduction is authorised provided the source is acknowledged What are the side-effects of Loxicom?
Reproduction is authorised provided the source is acknowledged Kif ġiet studjata l- effikaċja ta ’ Loxicom?
Occasional side effects of Loxicom are those seen with NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools, renal failure and apathy (lack of vitality).
Effetti sekondarji okkażjonali ta ’ Loxicom huma dawk li jidhru bl- NSAIDs, bħat- telf ta ’ aptit, rimetter, dijarrea, demm fil- feċi u apatija (nuqqas ta ’ vitalità).
These side effects occur generally within the first week of treatment and are usually temporary and disappear once treatment has stopped.
Dawn l- effetti sekondarji jiġru ġeneralment fi żmien ġimgħa mit- trattament u huma temporanji u jisparixxu ladarba t- trattament jiġi mwaqqaf.
In very rare cases they may be serious or fatal.
F’ każijiet verament rari, jistgħu jkunu serji jew fatali.
In the case of the solution for injection form, in very rare cases anaphylactoid (hypersensitive allergic) reactions may occur and should be treated symptomatically.
Fil- każ tas- soluzzjoni f’ forma ta ’ injezzjoni, f’ każijiet rari ta ’ reazzjoni anafilaktojde (ipersensittività allerġika) tista ’ tiġri u għandha tiġi ttrattata skond is- sintomi.
People who are hypersensitive (allergic) to NSAIDs should avoid contact with Loxicom.
Il- persuni ipersensittivi (allerġiċi) għall- NSAIDs għandhom jevitaw il- kuntatt ma 'Loxicom.
If the product is swallowed by a person, the advice of a doctor should be sought immediately.
Jekk il - prodott jinbela ’ minn persuna ghandu jitfittex parir mediku minnufih.
In the case of accidental ingestion or self-injection medical advice should be sought immediately, showing the package leaflet or label to the physician.
Fil- każ ta ’ inġestjoni aċċidentali jew li l- pazjent jinjetta lilu nnifsu b’ mod aċċidentali, wieħed għandu jfittex parir mediku minnufih u għandu juri l- Fuljett ta ’ Tagħrif jew it- tikketta lit- tabib.
Why has Loxicom been approved?
Għaliex ġie approvat Loxicom?
The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Loxicom has been shown to be bioequivalent to Metacam 1.5 mg/ ml oral suspension.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkunsidra li, skont ir- rekwiżiti tal- Unjoni Ewropea, Loxicom kien jidher bħala bijoekwivalenti għal Metacam 1. 5 mg/ ml ta ’ sospensjoni orali.
Therefore the CVMP’ s view was that, as for Metacam 1.5 mg/ ml oral suspension, Loxicom’ s benefits are greater than its risks when treating inflammation or pain in muscles or joints in dogs and they recommended that Loxicom 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 ’ Loxixom huma akbar mir- riskji tiegħu meta tiġi trattata l - infjammazzjoni jew uġigħ fil- muskoli jew fil- ġogi fil- klieb u rrakomanda li Loxicom għandu jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Loxicom solution for injection has been formulated to be essentially similar to Metacam solution for injection.
Is- soluzzjoni Loxicom għal injezzjoni ġiet formulata sabiex tkun essenzjalment simili għas- soluzzjoni Metacam għal injezzjoni.
Other information about Loxicom:
Aktar tagħrif dwar Loxicom:
The European Commission granted a marketing authorisation valid throughout the European Union, for Loxicom to Norbrook Laboratories Limited on 10/ 02/ 2009.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Loxicom lil Norbrook Laboratories Limited fil- 10 / 02 / 2009.
Information on the prescription status of this product may be found on the label of the carton.
Informazzjoni dwar l- istejtus tal - preskrizzjoni ta ’ dan il- prodott tista ’ tinstab fuq it- tikketta tal- kaxxa.
This summary was last updated:
Dan is- sommarju ġie aġġornat l- aħħar fi:
February 2009
Frar 2009
Page 2/ 2 ©EMEA 2009
Paġna 2/ 2 ©EMEA 2009
EU Number
Numru tal- EU
Withdrawal period
Perjodu ta ’ Tiżmin
Polyethylene terephtalate bottle, HDPE/ LDPE cap, polypropylene / polyethylene measuring syringe.
Flixkun tal - polyethylene terephtalate, għatu tal- HDPE/ LDPE, siringa tal- kejl tal- polypropylene / polyethylene
1 bottle with dosing syringe
1 flixkun b’ siringa tad- doża
Polyethylene terephtalate bottle, HDPE/ LDPE cap, polypropylene / polyethylene measuring syringe.
Flixkun tal - polyethylene terephtalate, għatu tal- HDPE/ LDPE, siringa tal- kejl tal- polypropylene / polyethylene.
EU/ 2/ 08/ 090/ 006 Loxicom
1/ 2 EU/ 2/ 08/ 090/ 006 Loxicom
Solution for Injection
Soluzzjoni għall- injezzjoni
Dogs and Cats
Klieb u Qtates
Glass vial with rubber stopper and aluminium cap
jingħata ġol- vina jew taħt il- ġilda
10 ml
Kunjett tal- ħġieġ 10 ml b’ tapp tal- lastku u għatu tal- aluminju
1 glass vial
1 kunjett tal- ħġieġ
Glass vial closed rubber stopper and aluminium cap
jingħata ġol- vina jew taħt il- ġilda
20 ml
Kunjett tal- ħġieġ 20 ml b’ tapp tal- lastku u għatu tal- aluminju
100 ml
Kunjett tal- ħġieġ 100 ml b’ tapp tal- lastku u għatu tal- aluminju
1/ 48 1.
1/ 51 1.
Loxicom 0.5 mg/ ml oral suspension for dogs Meloxicam
Loxicom 0. 5 mg/ ml suspensjoni orali għall- klieb Meloxicam
Active Substance:
Sustanza attiva:
For a full list of excipients, see section 6.1.
Għal- lista sħiħa ta ’ sustanzi mhux attivi, ara s- sezzjoni 6. 1.
Pale yellow oral suspension.
Suspensjoni orali ta ’ lewn safrani ċar.
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
Għal serħan mill- infjammazzjoni u uġigħ f’ disturbi muskolu- skeletriċi kemm akuti kif ukoll kroniċi fil- klieb.
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Tużax fuq annimali li jsofru minn disturbi gastrointestinali, bħal irritazzjoni jew emorraġija, jew annimali li għandhom indeboliment fil- funzjoni tal- fwied, tal- qalb jew tal- kliewi, u disturbi emorraġiċi.
Do not use in case of hypersensitivity to the active substance or to any of the excipients Do not use in dogs less than 6 weeks of age.
Tużax fuq klieb li għandhom inqas minn 6 ġimgħat.
4.5 Special precautions for use
2/ 51 4. 5 Prekawzjonijiet Speċjali għall- Użu
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Jekk ikun hemm reazzjonijiet avversi, it- trattament għandu jitwaqqaf u għandu jittieħed il- parir ta ’ veterinarju.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.
Evita l- użu fi kwalunkwe annimal li jkun diżidrat, ipovolemiku jew bil- pressjoni baxxa, għax hemm riskju potenzjali ta ’ tossiċità tal- kliewi.
2/ 48 Special precautions to be taken by the person administering the veterinary medicinal product to animals
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.
Persuni li jafu li għandhom sensittività eċċessiva għal prodotti anti- inflammatorji u mhux sterojdi (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 parir mediku minnufih u uri l- fuljett tal- pakkett jew it - tikketta lit- tabib.
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported.
Reazzjonijiet avversi tipiċi tal- mediċini NSAIDs bħal nuqqas t’ aptit, rimettar, dijarea, demm moħbi fl - ippurgar, apatija u insuffiċjenza renali kienu rrappurtati xi kultant.
These adverse reactions 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 ir- reazzjonijiet avversi ġeneralment iseħħu fi żmien l- ewwel ġimgħa tat- trattament, u f’ ħafna każijiet jgħaddu malajr u jisparixxu wara t- tmiem tat- trattament, iżda f’ każijiet rari ħafna, jistgħu jkunu serji jew fatali.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see section 4.3).
Is- sigurtà tal- prodott mediċinali veterinarju ma ġietx stabbilita waqt it- tqala u fi żmien il- ħalib (ara sezzjoni 4. 3).
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects.
NSAIDs oħrajn, dijuretiċi, antikoagulanti, antibijotiċi aminoglycoside u sustanzi oħra li jeħlu ħafna mal - proteini, jistgħu jikkompetu għat- twaħħil u b’ hekk iwasslu għal effetti tossiċi.
Loxicom must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Loxicom 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 veterinary medicinal products 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’ prodotti mediċini bħal dawn, qabel ma tibda t- trattament.
The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Madankollu, il- perjodu mingħajr trattament, irid jikkunsidra l - karatteristiċi farmakokinetiċi tal- prodotti użati qabel.
To be administered with food or directly into the mouth.
Għandu jingħata mal- ikel jew direttament fil- ħalq.
Shake well before use.
Ħawwad sew qabel tuża.
4 ml/ 10 kg bodyweight) on the first day.
It- trattament tal- bidu jikkonsisti minn doża waħda ta ’ 0. 2 mg ta ’ meloxicam/ kg ta ’ piż tal- ġisem fl- ewwel jum.
Treatment is to be continued once daily by oral administration (at 24 hour intervals) at a maintenance dose of 0.1 mg meloxicam/ kg bodyweight (i. e.
It- trattament għandu jitkompla darba kuljum bl- għoti orali (f’ intervalli ta ’ 24 siegħa) bid- doża tal - manteniment ta ’ 0. 1 mg meloxicam/ kg ta ’ piż tal- ġisem (i. e.
2 ml/ 10 kg bodyweight).
2 ml/ 10 kg piż tal- ġisem).
For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.
3/ 51 Għal trattament iktar fit- tul, ġaladarba r- rispons kliniku jkun ġie osservat (wara ≥ 4 ijiem), id- doża tista ’ tiġi aġġustata għall- inqas doża effettiva individwali, li tirrifletti li l- grad ta ’ uġigħ u ta ’ infjammazzjoni marbuta ma ’ disturbi muskolu- skeletriċi kroniċi, jista ’ jvarja matul iż- żmien.
The suspension can be given using either of the two measuring syringes provided in the package.
Is- suspensjoni tista ’ tingħata billi tuża waħda miż- żewġ siringi tal- kejl ipprovduti fil- pakkett.
The syringes fit onto the bottle and have a kg-bodyweight scale which corresponds to the maintenance dose (i. e.
Is- siringi jiffittjaw fil- flixkun u għandhom skala ta ’ kg ta ’ piż tal- ġisem li jikkorispondu mad- doża ta ’ manteniment (i. e.
0.1 mg meloxicam/ kg bodyweight).
0. 1 mg meloxicam/ kg piż korporali).
Thus for the first day, twice the maintenance volume will be required.
Għalhekk għall- ewwel jum, hu meħtieġ li jingħata d- doppju tal - volum ta ’ manteniment.
Alternatively therapy may be initiated with Loxicom 5 mg/ ml solution for injection.
Inkella, terapija tista ’ tinbeda b’ Loxicom soluzzjoni għall- injezzjoni 5 mg/ ml.
3/ 48 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti), jekk ikun hemm bżonn
In the case of overdose, symptomatic treatment should be initiated.
F’ każ ta ’ doża eċċessiva, għandu jinbeda trattament sintomatiku.
4.11 Withdrawal period
4. 11 Perjodu( i) ta ’ tiżmim
ATCvet code:
Prodotti anti- infjammatorji u anti- rewmatiċi, mhux sterojdi (oxicams) Kodici ATĊ veterinarja:
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects.
Meloxicam hu mediċina anti- infjammatorja mhux sterojda (NSAID) li tappartjeni għall- klassi oxicam li taġixxi bl- inibizzjoni tas- sintesi ta ’ prostaglandin, u b’ hekk teżerċita effetti antinfjammatorji, analġesiċi, kontra t- tnixxija u antipiretiċi.
It reduces leukocyte infiltration into the inflamed tissue.
Hu jnaqqas l- infiltrazzjoni tal- lewkoċiti fit- tessut infjammat.
To a minor extent it also inhibits collagen-induced thrombocyte aggregation.
Sa ċertu punt, hu jinibixxi l- aggregazzjoni tat- tromboċiti kkaġunata mill- kollaġen.
In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
Studji in vivo u in vitro wrew 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 4.5 hours.
Assorbiment Meloxicam huwa kompletament assorbit wara l- għoti mill- ħalq u l- ogħla konċentrazzjonijiet fil- plażma jinkisbu wara madwar 4. 5 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 skont il- kors rakkomandat tad- dożaġġ, il - konċentrazzjonijiet fl- istat fiss ta ’ meloxicam fil- plażma jintlaħqu fit- tieni jum ta ’ trattament.