qanastek/EMEA-V3 huggingface dataset:
Distribution There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range.
Distribuzzjoni Hemm relazzjoni linejari bejn id- doża mogħtija u l- konċentrazzjoni fil- plażma osservata fil- firxa tad- doża terapewtika.
The volume of distribution is 0.3 l/ kg.
Il- volum tad- distribuzzjoni hu ta ’ 0. 3 l/ kg.
Metabolism Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound.
4/ 51 Metaboliżmu Il- biċċa l- kbira ta ’ meloxicam jinsab fil- plażma u hu wkoll prodott ewlieni tal- eliminazzjoni biljari, filwaqt li l- awrina fiha biss traċċi tal- kompost prinċipali.
Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites.
Meloxicam huwa metabolizzat għal alkoħol, derivat ta ’ l- aċidu u għal diversi metaboliti polari.
All major metabolites have been shown to be pharmacologically inactive.
Intwera li l- metaboliti prinċipali kollha mhumiex farmakoloġikament attivi.
Approximately 75% of the administered dose is eliminated via faeces and the remainder via urine.
Madwar 75% tad- doża li tingħata tiġi eliminata fl- ippurgar, u l- bqija fl- awrina.
Sodium Benzoate Glycerol Povidone K30 Xanthan Gum Disodium Phosphate Dihydrate Sodium Dihydrogen Phosphate Dihydrate Citric Acid Anhydrous Simethicone Emulsion Purified water
Sodium Benzoate Glycerol Povidone K30 Gomma ta ’ xanthan Disodium Posphate Dihydrate Sodium Dihydrogen Phosphate Dihydrate Aċidu ċitriku anidru Emulsjoni ta ’ Simethicone Ilma purifikat
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Fin- nuqqas ta ’ studji dwar kompattibilità, dan il- prodott mediċinali veterinarju m’ għandux jitħallat ma prodotti mediċinali veterinarji oħra.
6.3 Shelf-life
6. 3 Żmien ta ’ kemm il- prodott idum tajjeb
Shelf-life of the veterinary medicinal product as packaged for sale:
18- il xahar.
18 months Shelf-life after first opening the immediate packaging:
Żmien li l- prodott jibqa ’ tajjeb wara li jkun tneħħa mill- ewwel ippakkjar:
6 months
6 xhur.
This veterinary medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali veterinarju m’ għandu bżonn l- ebda kundizzjoni speċjali sabiex jinħażen.
6.5 Nature and composition of immediate packaging
6. 5 In- natura u l- għamla tal- ewwel ippakkjar
The veterinary medicinal product is presented in 15 ml and 30 ml polyethylene screw bottles with HDPE/ LDPE child resistant caps.
Il- prodott mediċinali veterinarju huwa preżentat fi fliexken tal- kamin tal- poli- etilin ta ’ 15 ml u 30 ml b’ kappa tal- HDPE/ LDPE li hija reżistenti għall- ftuħ mit- tfal żgħar.
Two polyethylene/ polypropylene measuring syringes, a 1 ml and a 5 ml syringe, are supplied with each bottle to ensure accurate dosing of small and large dogs.
Ma kull flixkun huma provduti żewġ siringi tal- poli- etilin / polipropilin, waħda ta ’ 1ml u l- oħra ta ’ 5ml biex ikun żgurat dożaġġ preċiż għal klieb żgħar u kbar.
Each syringe is graduated in bodyweight, the 1 ml syringe is graduated from 0.25 kg to 5.0 kg and the 5 ml syringe for 1 kg to 25 kg.
Kull siringa hija gradata skont il- piż korporali, bis- siringa ta ’ 1 ml tkun gradata minn 0. 25 kg sa 5. 0 kg u s- siringa ta ’ 5 ml minn 1 kg sa 25 kg.
Not all pack sizes may be marketed.
Mhux id- daqsijiet kollha tal- pakketti jistgħu qegħdin fis- suq.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste material derived from the use of such products
5/ 51 6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użata jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Norbrook Laboratories Limited Station Works Newry Co.
Norbrook Laboratories Ltd Station Works Newry Co.
Down, BT35 6JP United Kingdom
Down, BT35 6JP Ir- Renju Unit
MARKETING AUTHORISATION NUMBER
NUMRU( I) TAL- AWTORIZZAZZJONI TAL- KUMMERĊ
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 tal- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /.
6/ 48 1.
6/ 51 1.
Loxicom 1.5 mg/ ml oral suspension for dogs.
Loxicom 1. 5 mg/ ml suspensjoni orali għall- klieb
Sodium Benzoate
Sodium benzoate
Pale yellow oral suspension.
Suspensjoni orali ta ’ lewn safrani car.
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.
Do no use in dogs less than 6 weeks of age.
Tużax fuq klieb li għandhom inqas minn 6 ġimgħat.
4.5 Special precautions for use
7/ 51 4. 5 Prekawzjonijiet Speċjali għall- Użu
7/ 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 sustanzi anti- inflammatorji u mhux sterojdi, (NSAIDs) għandhom jevitaw li jmissu mal- prodott mediċinali veterinarju.
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’ mediċini bħal dawn, qabel ma jibda t- trattament.
The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Madankollu, il- perjodu mingħajr trattament, irid jikkunsidra l- karatteristiċi farmakokinetiċi tal- prodotti użati qabel.
To be administered with food or directly into the mouth.
Użu orali Għandu jingħata mal- ikel jew direttament fil- ħalq.
1.33 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) b’ doża tal - manteniment ta ’ 0. 1 mg meloxicam/ kg ta ’ piż tal- ġisem (i. e.
0.667 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.
8/ 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.
Particular care should be taken with regard to the accuracy of dosing.
Għandha tingħata attenzjoni partikulari fir- rigward l- eżattezza tad- dożaġġ.
The suspension can be given using either of the two measuring syringes provided in the package (depending on weight of dog).
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 għal piż tal- ġisem li jikkorrispondu mad- doża tal - manteniment (i. e.
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 għal injezzjoni 5 mg/ ml.
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 sterojdi (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.
Distribution There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range in dogs.
Distribuzzjoni Hemm relazzjoni linejari bejn id- doża mogħtija u l- konċentrazzjoni fil- plażma osservata fil- firxa tad- doża terapewtika.
Metabolism Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound.
9/ 51 Metaboliżmu Il- biċċa l- kbira ta ’ meloxicam jinsab fil- plażma u hu wkoll prodott ewlieni tal- eliminazzjoni biljari, filwaqt li l- awrina fiha biss traċċi tal- kompost prinċipali.
Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites.
Meloxicam huwa metabolizzat għal alkoħol, derivat tal- aċidu u għal diversi metaboliti polari.
Sodium Benzoate Glycerol Povidone K30 Xanthan Gum Disodium Phosphate Dihydrate Sodium Dihydrogen Phosphate Dihydrate Citric Acid Anhydrous Simethicone Emulsion Purified water
Sodium Benzoate Glycerol Povidone K30 Gomma ta ’ xanthan Disodium Phosphate Dihydrate Sodium Dihydrogen Phosphate Dihydrate Aċidu ċitriku anidru Emulsjoni ta ’ Simethicone Ilma purifikat
None known.
Mhux applikabbli.
The veterinary medicinal product is presented in 10 ml, 32 ml and 100 ml polyethylene screw bottles with HDPE/ LDPE child resistant caps.
Il- prodott mediċinali veterinarju huwa preżentat fi fliexken tal- kamin tal- polyi- etilin ta ’ 10 ml, 32 ml, u 100 ml b’ kappa tal- HDPE/ LDPE li hija reżistenti ghall- ftuħ mit- tfal żgħar.
Two polyethylene/ polypropylene measuring syringes, a 1 ml and 5 ml syringe, are supplied with each bottle to ensure accurate dosing of small and large dogs.
Ma kull flixkun huma provduti żewġ siringi tal- poli- etilin / polipropilin, waħda ta ’ 1 ml u oħra ta ’ 5 ml bieux ikun żgurat dożaġġ preċiż ghal klieb żgħar u kbar.
Each syringe is graduated in bodyweight, the 1 ml syringe is graduated from 0.5 kg to 15 kg and the 5 ml syringe for 2.5 kg to 75 kg.
Kull siringa hija gradata skont il- piż korporali, bis- siringa ta ’ 1 ml tkun gradata minn 0. 5 kg sa 5. 0 kg u s- siringa ta ’ 5 ml minn 1 kg sa 25 kg.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste material derived from the use of such products
10/ 51 6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użati jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Norbrook Laboratories Limited Station Works Newry Co Down, BT35 6JP United Kingdom
Down, BT35 6JP L- Irlanda ta ’ Fuq
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TAL- AWTORIZZAZZJONI TAL- KUMMERĊ
11/ 48 1.
11/ 51 1.
Loxicom 5 mg/ ml solution for injection for dogs and cats.
Loxicom 5 mg/ ml soluzzjoni għall- injezzjoni għall- klieb u l- qtates.
Ethanol, anhydrous
Ethanol, anidru
Pale yellow solution for injection.
Soluzzjoni għall- injezzjoni ta ’ lewn isfar ċar.
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Għal serħan mill- infjammazzjoni u uġigħ f’ disturbi muskolu- skeletriċi kemm akuti kif ukoll kroniċi.
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.
Tnaqqis tal- uġigħ ta ’ wara operazzjoni tal- ovarjoisterektomija u ta ’ wara operazzjoni minuri tat- tessut artab.
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Tużax fuq annimali li jsofru minn mard gastrointestinali, bħal irritazzjoni jew emorraġija, jew annimali li għandhom indeboliment fil- funzjoni tal- fwied, tal- qalb jew tal- kliewi, u disturbi emorraġiċi.
12/ 48 4.5 Special precautions for use
12/ 51 4. 5 Prekawzjonijiet Speċjali għall- Użu
Do not use an oral follow-up therapy containing meloxicam or other non-steroidal anti-inflammatory drugs (NSAIDs) in cats, as no safe dosage for repeated oral administration has been established.
Tużax mediċini orali li fihom meloxicam jew mediċini kontra l- infjammazzjoni mhux sterojdi (NSAIDs) oħra f’ terapija sussegwenti fil - qtates, minħabba li għadu ma ġiex stabbilit dożaġġ sikur għall - amministrazzjoni ripetuta ta ’ dawn il- kuri orali
Accidental self-injection may give rise to pain.
Injezzjoni aċċidentali fuqek innifsek twassal għal uġigħ.
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Persuni li jafu li għandhom sensittività eċċessiva għal NSAIDs għandhom jevitaw li jmissu mal- prodott mediċinali veterinarju.
In dogs, 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.
Fil- klieb, dawn ir- reazzjonijiet avversi ġeneralment iseħħu fi żmien l- ewwel ġimgħa ta ’ trattament, u f’ ħafna każijiet jgħaddu malajr u jisparixxu wara t- tmiem tat- trattament, iżda f’ każijiet rari ħafna, jistgħu jkunu serji jew fatali.
In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
F’ każijiet rari ħafna, reazzjonijiet anafilattojdi jistgħu jseħħu u dawn għandhom jiġu kkurati b’ mod sintomatiku.
In animals at anaesthetic risk (e. g. aged animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration.
F’ annimali li jkunu f’ riskju tal - loppju (eż. annimali xjuħ), it- terapija bil- fluwidu ġol- vina jew taħt il- ġilda waqt il- loppju għandha tigi kkunsidrata.
When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.
Meta l- loppju u NSAID jingħataw flimkien, ma jistax jiġi eskluż li jista ’ jkun hemm riskju għall- funzjoni tal- kliewi.
The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Madankolu, il- perjodu mingħajr trattament, irid jikkunsidra l- karatteristiċi farmakokinetiċi tal- prodotti użati qabel.
4.9 Amounts to be administered and administration route
13/ 51 4. 9 Doża rakkomandata u l- metodu ta ’ amministrazzjoni
Musculo-skeletal disorders:
Disturbi muskolu- skeletriċi:
Single subcutaneous injection at a dosage of 0.2 mg meloxicam/ kg bodyweight (i. e.
Injezzjoni waħda taħt il- ġilda b’ doża ta ’ 0. 2 mg ta ’ meloxicam/ kg ta ’ piż tal - ġisem (i. e.
0.4 ml/ 10 kg bodyweight).
0. 4 ml/ 10 kg ta ’ piż tal- ġisem).
Loxicom 1.5 mg/ ml oral suspension and Loxicom 0.5 mg/ ml oral suspension may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/ kg bodyweight, 24 hours after administration of the injection.
Loxicom 1. 5 mg/ ml suspensjoni orali u Loxicom 0. 5 mg/ ml suspensjoni orali jistgħu jintużaw għat- tkomplija tat- trattament f’ doża ta ’ 0. 1 mg ta ’ meloxicam/ kg ta ’ piż tal- ġisem, 24 siegħa wara l- għoti tal -- injezzjoni.
13/ 48 Reduction of post-operative pain (over a period of 24 hours):
Tnaqqis ta ’ l- uġigħ ta ’ wara l- operazzjoni (matul perjodu ta ’ 24 siegħa):
Single intravenous or subcutaneous injection at a dosage of 0.2 mg meloxicam/ kg bodyweight (i. e.
Injezzjoni waħda ġol- vina jew taħt il- ġilda b’ doża ta ’ 0. 2 mg ta ’ meloxicam/ kg ta ’ piż tal- ġisem (i. e.
0.4 ml/ 10 kg bodyweight) before surgery, for example at the time of induction of anaesthesia.
0. 4 ml/ 10 kilogrammi ta ’ piż tal - ġisem), qabel l- operazzjoni, pereżempju meta jkun qed jingħata l- loppju.
Single subcutaneous injection at a dosage of 0.3 mg meloxicam/ kg bodyweight (i. e.
Injezzjoni waħda taħt il- ġilda b’ doża ta ’ 0. 3 mg ta ’ meloxicam/ kg ta ’ piż tal- ġisem (i. e.
0.06 ml/ kg bodyweight) before surgery, for example at the time of induction of anaesthesia.
0. 06 ml/ kg ta ’ piż tal- ġisem), qabel l- operazzjoni, pereżempju meta jkun qed jingħata l- loppju.
Absorption Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma concentrations of 0.73 µg/ ml in dogs and 1.1 µg/ ml in cats were reached approximately 2.5 hours and 1.5 hours post-administration, respectively.
Assorbiment Wara l- għoti taħt il- ġilda, meloxicam hu kompletament bijodisponibbli, u l- ogħla medja ta ’ konċentrazzjonijiet fil- plażma ta ’ 0. 73 µg/ ml, fil- klieb u 1. 1 µg/ ml fil- qtates intlaħqu wara madwar 2. 5 sigħat u 1. 5 sigħat wara l- għoti rispettivament.
Distribution There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range in dogs.
14/ 51 Distribuzzjoni Hemm relazzjoni linejari bejn id- doża mogħtija u l- konċentrazzjoni fil- plażma osservata fil- firxa tad- dożi terapewtiċi fil- klieb.
Metabolism In dogs, meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound.
Metaboliżmu Fil- klieb, il- biċċa l- kbira ta ’ meloxicam jinsab fil- plażma u hu wkoll prodott ewlieni tal- eliminazzjoni biljari, filwaqt li l- awrina fiha biss traċċi tal- kompost prinċipali.
14/ 48 Elimination Meloxicam is eliminated with a half-life of 24 hours in dogs and 15 hours in cats.
Eliminazzjoni Meloxicam jiġi eliminat b’ half- life ta ’ 24 siegħa fil- klieb u 15- il siegħa fil- qtates.
Meglumine Glycine Ethanol (anhydrous) Poloxamer 188 Sodium Chloride Glycofurol Sodium Hydroxide (for pH adjustment) Hydrochloric Acid (for pH adjustment) Water for Injection
Meglumine Glycine Ethanol (anhydrous) Poloxamer 188 Klorid tas- sodjum Idrossidu tas- sodjumGlycofurol Ilma għall- injezzjoni
28 days
28 jum.
6.5 Nature and composition of immediate packaging
6. 5 In natura u l- għamla tal- ewwel ippakkjar
Colourless glass injection vial of 10, 20 or 100 ml, closed with a bromobutyl stopper and sealed with an aluminium cap.
Kunjett tal- ħġieġ għall- injezzjoni, ta ’ 10, 20 jew 100 ml, mingħajr kulur, magħluq b’ tapp tal- lastku ussiġillat b’ kappa tal- aluminjum.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste material derived from the use of such products
15/ 51 6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użati jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Norbrook Laboratories Limited Station Works Newry Co Down, BT35 6JP United Kingdom
Down, BT35 6JP Ir- Renju Unit
PROHIBITION OF SALE, SUPPLY AND/ OR USE
PROJBIZZJONI TA ’ BEJGĦ, PROVVISTA, U/ JEW UZU
16/ 48 ANNEX II
16/ 51 ANNESS II
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TAL- AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL- PROVVISTA JEW L- UŻU
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TAL- AWTORIZZAZZJONI TAL- KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV
17/ 48 A.
17/ 51 A.
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL - LOTT
Name and address of the manufacturer responsible for batch release:
Isem u indirizz tal- manifattur responsabbli mill- ħruġ tal- lott.
Norbrook Laboratories Limited 105 Armagh Road Newry Co.
Norbrook Laboratories Ltd Station Works Newry Co.
Down, BT35 6PU United Kingdom
Down, BT35 6JP Ir- Renju Unit
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TAL- AWTORIZZAZZJONI TAL - KUMMERĊ FUQ IL- PROVVISTA JEW L- UŻU
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TAL- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV
STATEMENT OF THE MRLs
DIKJARAZZJONI TAL- MRLs
18/ 48 ANNEX III
18/ 51 ANNESS III
19/ 48 A.
19/ 51 A.
20/ 48 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
20/ 51 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton box 15 and 30 ml bottle
Kaxxa tal- kartuna Flixkun ta ’ 15 ml u 30 ml
Loxicom 0.5 mg/ ml oral suspension for dogs
Loxicom 0. 5 mg/ ml suspensjoni orali għall- klieb
Each ml contains:
Kull ml fih
Oral suspension.
Suspensjoni orali
15 ml 30 ml
5 ml 30 ml
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Għal serħan mill- infjammazzjoni u l- uġigħ f’ disturbi muskolu- skeletriċi kemm akuti kif ukoll kroniċi.
To be administered with food or directly into the mouth.
Sabiex jingħata mal- ikel jew direttament fil- ħalq.
Avoid introduction of contamination during use.
Evita li tikkontamina waqt l- użu.
8.
21/ 51 8.
Once opened use within 6 months.
Jiskadi {xahar/ sena} La darba jinfetaħ uża fi żmien 6 xhur.
This veterinary medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali veterinarju m’ għandux bżonn kundizzjonijiet speċjali ta ’ ħażna.
Dispose of waste material in accordance with local requirements.
Armi l- materjal ħażin skont kif titlob il- liġi tal- pajjiż.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM "GĦAL TRATTAMENT TAL- ANNIMALI BISS ” U KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVVISTA U L- UZU, jekk applikabbli
For animal treatment only – to be supplied only on veterinary prescription.
Għal trattament tal- annimali biss - għandu jingħata biss bi preskrizzjoni veterinarja.
THE WORDS “ KEEP OUR OF THE REACH AND SIGHT OF CHILDREN”
IL- KLIEM “ ŻOMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL ”
16.
22/ 51 16.
MARKETING AUTHORISATION NUMBER(S)
NUMRI TAL- AWTORIZZAZZJONI TAL- KUMMERĊ
EU/ 2/ 08/ 090/ 001 [15 ml] EU/ 2/ 08/ 090/ 002 [30 ml]
EU/ 2/ 08/ 090/ 01 [15 ml] EU/ 2/ 08/ 090/ 02 [30 ml]
MANUFACTURERS BATCH NUMBER
NUMRU TAL- LOTT TAL- MANIFATTUR
BN:
Lott {numru}
22/ 48 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
23/ 51 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
15 and 30 ml bottle
Flixkun ta ’ 15 u 30 ml
0.5 mg/ ml
0. 5 mg
CONTENT BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
KONTENUT BĦALA PIŻ, VOLUM JEW NUMRU TA ’ DOŻI
Once opened, use within 6 months
Jiskadi {xahar/ sena} La darba jinfetaħ uża fi żmien 6 xhur
For animal treatment only.
Għal trattament tal- annimali biss
23/ 48 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
24/ 51 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton box 10, 32 and 100 ml bottle
Kaxxa tal- kartun flixkun ta ’ 10, 32 u 100 ml
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA ATTIVA U SUSTANZI OĦRA
Oral Suspension.
Suspensjoni Orali
PACKAGE SIZES
DAQS TAL- PAKKETT
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
Għal serħan mill- infjammazzjoni u l- uġigħ f’ disturbi muskolu- skeletriċi kemm akuti kif ukoll kroniċi.
8.
25/ 51 8.
Once opened use within 6 months.
Jiskadi {xahar/ sena} Jekk tiftaħ uża fi żmien 6 xhur.
11 SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET SPEĊJALI DWAR KIF GĦANDU JINĦAŻEN
12 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
For animal treatment only - to be supplied only on veterinary prescription.
Għal trattament tal- annimali biss - għandu jingħata biss bi preskrizzjoni veterinarja
16.
26/ 51 16.
25/ 48 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
27/ 51 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
100 ml bottle
Flixkun ta ’ 100 ml
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA U SUSTANZI OĦRA
Oral Suspension.
Suspensjoni orali
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
Għal serħan mill- infjammazzjoni u l- uġigħ f’ disturbi muskolu- skeletriċi kemm akuti kif ukoll kroniċi fil- klieb.
8.
28/ 51 8.
For animal treatment only - to be supplied only on veterinary prescription.
Għal trattament tal- annimali biss - għandu jingħata biss bi preskrizzjoni veterinarja.
16.
29/ 51 16.
27/ 48 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
30/ 51 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
10 and 32 ml bottle
Flixkun ta ’ 10 ml u 32 ml
QUANTITY OF THE ACTIVE SUBSTANCE(S)
KWANTITÀ TAS- SUSTANZA ATTIVA/ SUSTANZI ATTIVI
WITHDRAWAL PERIOD
5 ŻMIEN TA ’ TIŻMIN
Once opened, use within 6 months.
Jiskadi{ xahar/ sena} La darba jinfetaħ uża fi żmien 6 xhur.
28/ 48 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
31/ 51 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton box 10 ml, 20 ml and 100 ml bottle
Kaxxa tal- kartun tal- flixkun ta ’ 10 ml, 20 ml u 100 ml
Loxicom 5 mg/ ml solution for injection for dogs and cats
Loxicom 5 mg/ ml soluzzjoni għall- injezzjoni għall- klieb u l- qtates
TARGET SPECIES
SPEĊI LI GĦAL XIEX HUWA INDIKAT IL- PRODOTT
Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.
Biex jitnaqqas l- uġigħ u l- infjammazzjoni wara operazzjoni ortopedika u tat- tessut artab.
7.
32/ 51 7.
Musculo-skeletal disorders: single subcutaneous injection.
Mard muskolu- skeletriku: injezzjoni waħda taħt il- ġilda.
Post-operative pain: single intravenous or subcutaneous injection.
Uġigħ ta ’ wara l- operazzjoni: injezzjoni waħda ġol- vina jew taħt il- ġilda.
Post-operative pain: single subcutaneous injection.
Uġigħ ta ’ wara l- operazzjoni: injezzjoni waħda taħt il- ġilda.
Shelf-life of broached vial:
Jiskadi Kunjett miftuħ idum tajjeb:
This veterinary medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali veterinarju m’ għandux bżonn ta ’ l- ebda kundizzjoni speċjali sabiex jinħażen.
Dispose of waste material in accordance with local requirements.
Armi l- materjal ħażin skont kif titlob il- liġi tal- pajjiż
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM "GĦAL TRATTAMENT TAL- ANNIMALI BISS ” U KUNDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVVISTA U L- UZU, jekk applikabbli
For animal treatment only -to be supplied only on veterinary prescription.
Għal trattament tal- annimali biss - għandu jingħata biss bi preskrizzjoni veterinarja.
14.
33/ 51 14.
MARKETING AUTHORISATION NUMBER(S)
NUMRU/ I TAL- AWTORIZZAZZJONI TAL- KUMMERĊ
31/ 48 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
34/ 51 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Għal serħan mill- infjammazzjoni u l- uġigħ f’ disturbi muskolu- skeletriċi kemm akuti u kroniċi.
7.
35/ 51 7.
SPECIAL WARNING(S), IF NECESSARY
TWISSIJA( IET) SPEĊJALI OĦRA, JEKK MEĦTIEĠ
Shelf-life of broached vial:
{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
For animal treatment only -to be supplied only on veterinary prescription.
Għal trattament ta ’ l- annimali biss - għandu jingħata biss bi preskrizzjoni veterinarja.
14.
36/ 51 14.
BN:
Lott: {numru}
34/ 48 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
37/ 51 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
10 and 20 ml bottle
Flixkun ta ’ 10 u 20 ml
QUANTITY OF THE ACTIVE SUBSTANCE(S)
KWANTITÀ TAS- SUSTANZA ATTIVA
Cats: subcutaneous use.
Klieb: jingħata ġol- vina jew taħt il- ġilda Qtates: jingħata taħt il- ġilda
BN:
{numru}
Shelf-life of opened bottle:
Jiskadi {xahar/ sena} Kunjett miftuħ idum tajjeb:
Once broached, use by ……………………….
Ladarba jinfetaħ, uża sa …………………
35/ 48 B.
38/ 51 B.
36/ 48 PACKAGE LEAFLET FOR
39/ 51 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 TAL- AWTORIZZAZZJONI TAL- KUMMERĊ U TAS - SID TAL- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L - KONSENJA TMUR FIS- SUQ, JEKK DIFFERENTI
Marketing authorisation holder Norbrook Laboratories Limited Station Works Newry Co.
Sid l- Awtorizzazzjoni tal- Kummerċ Norbrook Laboratories Limited Station Works Newry Co.
Manufacturer for the batch release Norbrook Laboratories Limited 105 Armagh Road Newry Co.
Manifattur li jħalli l- konsenja tmur fis- suq Norbrook Laboratories Limited 105 Armagh Road Newry Co.
Down, BT35 6PU United Kingdom
Down, BT35 6PU Ir- Renju Unit
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA( I) U SUSTANZA( I) OĦRA
37/ 48 6.
40/ 51 6.
Typical adverse 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 bħal ta ’ Mediċini Mhux Sterojdi ta ’ Kontra l- Infjammazzjoni (NSAIDs) bħal nuqqas t’ aptit, rimettar, dijarea, demm moħbi fl- ippurgar, apatija u insuffiċjenza renali kienu rrappurtati xi kultant.
Dosage:
Dożaġġ
Initial treatment is a single dose of 0.2 mg meloxicam/ kg bodyweight (i. e.
It- trattament tal- bidu tikkonsisti minn doża waħda ta ’ 0. 2 mg ta ’ meloxicam/ kg ta ’ piż tal- ġisem (i. e.
4 ml/ 10 kg bodyweight) on the first day.
4 ml/ 10 kg 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.
Għal trattament iktar fit- tul, ġaladarba r- rispons kliniku jkun ġie osservat (wara ≥ 4 ijiem), id- doża ta ’ Loxicom tista ’ tiġi aġġustata għall- inqas doża effettiva individwali, li tirrifletti li l- grad ta ’ uġigħ u ta ’ infjammazzjoni marbuta ma ’ disturbi muskolu- skeletriċi kroniċi, jistgħu jvarjaw matul iż- żmien.
Method and route of administration:
Mod ta ’ kif u mnejn jingħata
To be administered with food or directly into the mouth.
Użu orali Biex jingħata imħallat mal- ikel jew direttamemt fil- ħalq.
The suspension can be given using either of the two measuring syringes provided in the package.
Is- suspensjoni tista ’ tingħata permezz tas- 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 għal piż tal- ġisem li ikkorrispondu mad- doża tal- manteniment (i. e.
Thus for initiation of the therapy on the first day, twice the maintenance volume will be required.
Għalhekk, għall- ewwel jum, hu meħtieġ li jingħata d- doppju tal - volum ta ’ manteniment.
A clinical response is normally seen within 3-4 days.
Rispons kliniku ġeneralment ikun osservat wara 3- 4 ijiem.
Please carefully follow the instructions of the veterinarian.
Jekk jogħġbok segwi b’ attenzjoni l- istruzzjonijiet tal- veterinarju.
10.
41/ 51 10.
Do not use after the expiry date stated on the carton and the bottle.
Tużax wara d- data ta ’ l- iskadenza fuq il- kartuna u l- flixkun.
Precautions for use in animals
Prekawzjonijiet għall- użu fl- annimali
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 dizidrat, ipovolemiku jew bil- pressjoni baxxa, għax hemm riskju potenzjali ta ’ tossiċità tal- kliewi.
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 aminoglikosidi u sustanzi oħra li jabbinaw ħafna mal- proteini, jistgħu jikkompetu għal abbinament u b’ hekk iwasslu għal effetti tossiċi.
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 bi prodotti mediċinali veterinarji bħal dawn, qabel ma jinbeda t- trattament.
The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Madankollu, fil- perjodu mingħajr trattament, għandhom jitqiesu l- karatteristiċi farmakokinetiċi tal- prodotti użati qabel.
Precautions to be taken by the person administering the product
Prekawzjonijiet li għandhom jittieħdu mill- persuna li tamministra l- prodott
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Persuni li huma magħrufin 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 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.
Medicines should not be disposed of via waste water or household waste.
Il- mediċini m’ għandhomx jiġu mormija mal- ilma jew mal- iskart domestiku.
These measures should help to protect the environment.
Staqsi lil veterinarju tiegħek dwar kif l- aħjar li tarmi l- mediċini li ma jkunux aktar meħtieġa minnek.
14.
42/ 51 14.
Polyethylene bottle containing 15 or 30 ml with two polyethylene/ polypropylene measuring syringes.
Flixkun tal- polyethylene li fih 15 jew 30 ml b’ żewġ siringi tal- kejl tal- polyethylene/ polypropylene.
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
40/ 48 PACKAGE LEAFLET FOR
43/ 51 FULJETT TA ’ TAGĦRIF FIL- PAKKETT:
Loxicom 1.5 mg/ ml oral suspension for dogs
Loxicom 1. 5 mg/ ml suspensjoni orali għall- klieb
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING, AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT
L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ U TAS - SID TAL- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L - KONSENJA TMUR FIS- SUQ, JEKK DIFFERENTI
Marketing authorisation holder Norbrook Laboratories Limited Station Works Newry Co.
Sid l- Awtorizzazzjoni tal- KummerċNorbrook Laboratories Limited Station Works Newry Co.
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA( I) U SUSTANZI( I) OĦRA
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Għas- serħan mill- infjammazzjoni u uġigħ f’ disturbi muskolu- skeletriċi kemm akuti kif ukoll kroniċi.
41/ 48 6.
44/ 51 6.
If you notice any serious effects or 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.
Initial treatment is a single dose of 0.2 mg meloxicam/ kg bodyweight (i. e.
It- trattament tal- bidu jikkonsisti minn doża waħda ta ’ 0. 2 mg ta ’ meloxicam/ kg ta ’ piż tal- ġisem (i. e.
1.33 ml/ 10 kg bodyweight) on the first day.
1. 33 ml/ 10 kg piż tal- ġisem) fl- ewwel jum.
Treatment is to be continued once daily by oral administration (at 24 hour interval) 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.
0.667 ml/ 10 kg bodyweight).
0. 667 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.
Għal trattament iktar fit- tul, ġaladarba r- rispons kliniku jkun ġie osservat (wara ≥ 4 ijiem), id- doża ta ’ Loxicom tista ’ tiġi aġġustata għall- inqas doża effettiva individwali, li tirrifletti l- grad ta ’ uġigħ u ta ’ infjammazzjoni marbuta ma ’ disturbi muskolu- skeletriċi kroniċi, li jistgħu jvarjaw matul iż- żmien.
To be administered with food or directly into the mouth.
Biex jingħata imħallat mal- ikel jew direttamemt fil- ħalq.
Shake well before use.
Ħawwad tajjeb qabel l- użu
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 jikkorrispondu mad- doża tal- manteniment (i. e.
Thus for initiation of the therapy on the first day, twice the maintenance volume will be required.
Għalhekk, għall- ewwel jum, hu meħtieġ li jingħata d- doppju tal- volum ta ’ manteniment.
9.
45/ 51 9.
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 aminoglikosidi u sustanzi oħra li jabbinaw ħafna mal- proteini, jistgħu jikkompetu għat- abbinament u b’ hekk iwasslu għal effetti tossiċi.
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 mediċinali veterinarji bħal dawn, qabel ma jinbeda t- trattament.
In the case of overdose symptomatic treatment should be initiated.
F’ każ ta ’ doża eċċessiva, għandu jinbeda trattament sintomatiku.
13.
46/ 51 13.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, if any
PREKAWZJONIJIET SPEĊJALI DWAR RIMI TA ’ PRODOTT MHUX UŻAT JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jiġu mormija mal- ilma jew mal- iskart domestiku.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED
DATA META ĠIE APPROVAT L- AĦĦAR IL- FULJETT FIL- PAKKETT
Polyethylene bottle containing 10, 32 or 100 ml with two polyethylene/ polypropylene measuring syringes.
Flixkun tal- polyethylene li fih 10, 32, jew 100 ml b’ żewġ siringi tal- kejl tal- polyethylene/ polypropylene.
44/ 48 PACKAGE LEAFLET FOR
47/ 51 FULJETT TA ’ TAGĦRIF FIL- PAKKETT:
Loxicom 5 mg/ ml solution for injection for dogs and cats
Loxicom 5 mg/ ml soluzzjoni għall- injezzjoni għall- klieb u l- qtates.
Loxicom 5 mg/ ml solution for injection for dogs and cats
Loxicom 5 mg/ ml soluzzjoni għal injezzjoni għall- klieb u l- qtates.
5.
48/ 51 5.
Typical adverse 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 bħal ta ’ Mediċini Mhux Sterojdi ta ’ Kontra l- Infjammazzjoni (NSAIDs) bħal nuqqas t’ aptit, rimettar, dijarea, demm moħbi fl- ippurgar, apatija u insuffiċjenza renali kienu rrappurtati xi kultant.
In dogs, 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.
Fil- klieb, 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.
In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
F’ każijiet rari ħafna, reazzjonijiet anafilattiċi jistgħu jseħħu u dawn għandhom jiġu kkurati b’ mod sintomatiku.
Dosage for each species:
Dożaġġ għal kull speċi
Dogs: single administration of 0.2 mg meloxicam/ kg bodyweight (i. e.
Klieb: għoti ta ’ darba ta ’ 0. 2 mg meloxicam/ kg ta ’ piż tal- ġisem (i. e.
Cats: single administration of 0.3 mg meloxicam/ kg bodyweight (i. e.
Qtates: għoti ta ’ darba ta ’ 0. 3 mg meloxicam/ kg ta ’ piż tal- ġisem (i. e.
Musculo-skeletal disorders: single subcutaneous injection.
Disturbi muskolu- skeletriċi: injezzjoni waħda taħt il- ġilda.
Loxicom 1.5 mg/ ml oral suspension or Loxicom 0.5 mg/ ml oral suspension may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/ kg bodyweight, 24 hours after administration of the injection.
Loxicom 1. 5 mg/ ml suspensjoni orali għall- klieb jew Loxicom 0. 5 mg/ ml; suspensjoni orali jistgħu jintużaw għat- tkomplija tat- trattament f’ doża ta ’ 0. 1 mg ta ’ meloxicam/ kg ta ’ piż tal- ġisem, 24 siegħa wara l- għoti ta ’ l- injezzjoni.
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery: single subcutaneous injection before surgery, for example at the time of induction of anaesthesia.
Tnaqqis ta ’ l- uġigħ ta ’ wara l- operazzjoni ta ’ l- ovarjoisterektomija u ta ’ wara operazzjoni minuri tat- tessut artab: injezzjoni waħda taħt il- ġilda qabel l- operazzjoni, pereżempju meta jkun qed jingħata l- loppju.
9.
49/ 51 9.
Particular care should be taken with regard to the accuracy of dosing.
Għandha tingħata attenzjoni partikulari fir- rigward tal- eżattezza tad- dożaġġ.
Do not use after the expiry date stated on the carton and the bottle.
Tużax wara d- data tal- iskadenza fuq il- kartuna u l- flixkun.
If adverse effects 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 increased renal toxicity.
Evita l- użu fi kwalunkwe annimal li jkun deidratat, ipovolemiku jew bi pressjoni baxxa, għax hemm riskju potenzjali ta ’ tossiċità tal- kliewi.
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 aminoglajkosajds u sustanzi oħra li jabbinaw ħafna mal- proteini, jistgħu jikkompetu għal abbinament u b’ hekk iwasslu għal effetti tossiċi.
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’ prodotti mediċinali veterinarji bħal dawn, qabel ma jinbeda t- trattament.
Precautions to be taken by the person administering the product Accidental self-injection may give rise to pain.
50/ 51 Prekawzjonijiet li għandhom jittieħdu mill- persuna li tamministra l- prodott
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Nies li huma sensittivi għal prodotti anti - inflammatorji u mhux sterojdi (NSAIDs) għandhom jevitaw li jmissu mal- prodott mediċinali veterinarju.
In case of accidental self-injection, seek medical advice immediately and show this package leaflet or the label to the physician.
F’ każ li tinjetta b’ mod aċċidentali lilek innifsek, fittex parir mediku minnufih u uri l- fuljett tal- pakkett jew it- tikketta lit- tabib.
10 ml, 20 ml or 100 ml injection vial.
Kunjett ta ’ l- injezzjoni ta ’ 10 ml, 20 ml jew 100 ml.
48/ 48
51/ 51
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
L - għan tiegħu huwa li jispjega kif il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) abbażi tad- dokumentazzjoni pprovduta, wasal għar- rakkomandazzjonijiet dwar il - kundizzjonijiet tal- użu.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq aktar informazzjoni abbażi tar- rakkomandazzjonijiet tas- CVMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Masivet?
X’ inhu Masivet?
Masivet contains masitinib, which belongs to a class of medicines having an anticancer action.
Masivet fih masitinib, li jagħmel parti mill- klassi ta ’ mediċini li għandhom azzjoni kontra l - kanċer.
It is available as round, orange tablets (50 and 150 mg).
Jiġi bħala pilloli tondi, oranġjo (50 u 150 mg).
What is Masivet used for?
Għalxiex jintuża Masivet?
Masivet is used to treat dogs with mast-cell tumours (a type of cancer).
Masivet jintuża biex jikkura klieb b’ tumuri taċ- ċelluli- mast (tip ta ’ kanċer).
It is used for tumours which are severe in character (grade 2 or 3) and which cannot be removed with surgery.
Huwa jintuża għal tumuri li huma serji fin- natura tagħhom (grad 2 jew 3) u li ma jistgħux jitneħħew bil- kirurġija.
It is only used if the presence of a mutated form of the receptor protein c-kit in the tumours has been confirmed before the start of treatment.
Huwa jintuża biss jekk il- preżenza ta ’ forma mibdula b’ mod ġenetiku tas- c- kit tal- proteina tar - riċettur tkun ġiet ikkonfermata qabel il- bidu tal- kura.
The tablets are given by mouth, once a day.
Il- pilloli jittieħdu mill- ħalq, darba kuljum.
The dose depends on the weight of the dog being treated..
Id- doża tiddependi fuq il- piż tal- kelb li jkun qed jiġi kkurat.
The duration of treatment depends on the dog’ s response to treatment.
It- tul ta ’ żmien tal- kura jiddependi fuq ir- reazzjoni tal- kelb għall- kura.
How does Masivet work?
Kif jaħdem Masivet?
The active substance in Masivet, masitinib, is a protein-tyrosine kinase inhibitor.
Is- sustanza attiva f’ Masivet, masitinib, hija impeditur ta ’ protein- tyrosine kinase.
This means that it blocks some specific enzymes known as tyrosine kinases.
Dan ifisser li timblokka xi enzimi speċifiċi fuq il- wiċċ taċ- ċelloli.
These enzymes can be found in some receptors on the surface of cells, including the c-kit receptor.
Dawn l- enzimi jinsabu f’ xi riċetturi fuq il- wiċċ taċ- ċelloli, inklużi r- riċettur c- kit.
Some types of mast-cell tumour are linked to a mutation that causes excessive action of c-kit and stimulates the mast cells to divide uncontrollably.
Xi tipi ta ’ tumur taċ- ċelluli- mast huma marbutin ma ’ tibdil ġenetiku li jikkaġuna azzjoni eċċessiva ta ’ c- kit u jistimula liċ- ċelluli mast biex jinqasmu mingħajr kontroll.
By blocking these receptors, Masivet might help to control cell division, preventing further development of the tumours with this particular mutation.
Billi jimblokka dawn ir- riċetturi, Masivet jista ’ jgħin biex jikkontrolla il- qsim taċ- ċelluli, u ma jħallix iktar żvilupp tat- tumuri b’ dan it- tibdil ġenetiku partikolari.