qanastek/EMEA-V3 huggingface dataset:
Fluoxetine inhibits catecholamine uptake only at high concentrations in vitro and has no effect on catecholamine uptake in vivo at doses that are used to inhibit serotonin uptake.
Fluoxetine jimpedixxi t- teħid ta ’ katekolamin f’ konċentrazzjonijiet għoljin in vitro u m’ għandux effett fuq it- teħid ta ’ katekolamin in vivo f’ dożi li jintużaw biex jimpedixxu t- teħid ta ’ serotonin.
As a result of inhibiting serotonin uptake, fluoxetine enhances serotonergic neurotransmission and produces functional effects resulting from increased activation of serotonin receptors.
Bħala riżultat ta ’ l - inibizzjoni tat- teħid ta ’ serotonin, fluoxetine jintensifika n- newrotrassmissjoni serotonerġika u jipproduċi effetti funzjonali li jirriżultaw mill- attivazzjoni ogħla ta ’ riċettaturi ta ’ serotonin.
Fluoxetine lacks any significant affinity for neurotransmitter receptors, including the muscarinic cholinergic receptor, α adrenergic receptors, or histaminergic H1 receptors, and does not have direct effects on the heart.
Fluoxetine m’ għandux affinità sinifikanti għal riċettaturi newrotrasmettituri li jinkludu r- riċettatur kolinġeriku muskariniku, riċettaturi adrenerġiċi α, jew riċettaturi ħistaminerġiċi H1 u m’ għandux effetti diretti fuq il- qalb.
5.2 Pharmacokinetic particulars
4/ 33 5. 2 Tagħrif Farmakokinetiku
Fluoxetine is well absorbed after oral administration (~72%) and the absorption is not affected by feeding.
Fluoxetine jiġi assorbit tajjeb wara li jittieħed mill- ħalq (~72%) u l- assorbiment mhux affettwat bit - teħid ta ’ l- ikel.
Fluoxetine is metabolised to norfluoxetine, an equipotent SSRI that contributes to the efficacy the product.
Fluoxetine huwa metabolizzat għal norfluoxetine, SSRI ekwipotenti li jikkontribwixxi għall- effikaċja tal- prodott.
4/ 33 In a 21 day study, fluoxetine was administered daily at a dose of 0.75, 1.5 and 3.0 mg/ kg to laboratory Beagles.
Fi studju li dam sejjer 21 jum, fluoxetine ġie amministrat kuljum f’ dożi ta ’ 0. 75, 1. 5 u 3. 0 mg/ kg lil Beagles tal- laboratorju.
The maximum plasma concentration (Cmax) and area under the plasma concentration time curve (AUC) for fluoxetine were approximately dose proportional between 0.75 and 1.5 mg/ kg, with a greater than dose proportional increase at 3 mg/ kg.
Il- konċentrazzjoni massima fil- plażma (Cmax) u l- erja taħt il- kurva ta ’ konċentrazzjoni fil- plażma mal- ħin (AUC) għal fluoxetine kienu kważi proporzjonali fid- dożi ta ’ 0. 75 u 1. 5 mg/ kg, b’ żieda proporzjonali akbar fid- doża ta ’ 3 mg/ kg.
After administration, fluoxetine readily appeared in plasma with mean Tmax values ranging from 1.25 to 1.75 hours on day 1 and from 2.5 to 2.75 hours on day 21.
Wara l- għoti, fluoxetine deher malajr fil- plażma b’ valuri ta ’ Tmax medji li jvarjaw minn 1. 25 sa 1. 75 sigħat fl- 1 jum u minn 2. 5 sa 2. 75 sigħat fil- 21 jum.
Plasma levels readily declined with mean t½ values ranging from 4.6 to 5.7 hours on day 1 and from 5.1 to 10.1 on day 21.
Il- livelli fil- plażma niżlu malajr b’ valuri medji ta ’ t½ li kienu jvarjaw minn 4. 6 sa 5. 7 sigħat fl- 1 jum u minn 5. 1 sa 10. 1 fil- 21 jum.
Norfluoxetine plasma levels slowly appeared in plasma and were slowly eliminated with t½ values ranging from 44.2 to 48.9 hours on day 21.
Livelli fil- plażma ta ’ norfluoxetine u kienu eliminati bil- mod b’ valuri t½ li jvarjaw minn 44. 2 sa 48. 9 siegħa f’ jum 21.
Norfluoxetine Cmax and AUC were generally dose proportional but these values were 3 to 4 hold higher on day 21 than on Day 1.
Cmax u AUC ta ’ norfluoxetine kienu ġeneralment proporzjonali għad- doża imma dawn il- valuri kienu minn 3 sa 4 darbiet ogħla fil- 21 jum milli f’ 1 Jum.
Accumulation of fluoxetine and norfluoxetine occurred following multiple doses until reaching a steady-state within approximately 10 days.
L- akkumulazzjoni ta ’ fluoxetine u norfluoxetine seħħew wara dożi multipli sakemm laħqu livell ta ’ stadju fiss f’ madwar 10 ijiem.
Following the last dose administration, fluoxetine and norfluoxetine plasma levels declined steadily in a log-linear fashion.
Wara l- aħħar amministrazzjoni tad- doża, il- livelli tal- plażma ta ’ fluoxetine u norfluoxetine naqsu b’ mod konsistenti f’ xejra log- linejari.
Elimination studies in dogs have shown that 29.8% and 44% of the dose was excreted in urine and faeces, respectively by 14 days following dosing.
Studji ta ’ eliminazzjoni fil - klieb urew li 29. 8% u 44% tad- doża ġiet eliminata fl- awrina u fl- ippurgar rispettivament sa 14- il jum wara li tkun ingħatat id- doża.
Microcrystalline Cellulose Sucrose (as Compressible Sugar NF) Crospovidone Artificial beef flavour Silica, colloidal anhydrous Calcium hydrogen phosphate dihydrate Magnesium stearate
Microcrystalline Cellulose Zokkor (bħala Zokkor Ikkompressat) Krospovidone Togħma artifiċjali ta ’ ċanga Silika, kolloide u anhidra Calcium hydrogen phosphate dihydrate
Shelf-life after first opening the immediate packaging:
Żmien li l- prodott jibqa ’ tajjeb wara li jinfetaħ il- pakkett immedjat:
30 days.
30 jum.
Discard any tablets remaining in the container after use.
Armi kull pillola li tibqa ’ fir- reċipjent wara l- użu.
Do not store above 30°C.
Taħżinx f' temperaturi ogħla minn 30oC.
Keep the bottle tightly closed in order to protect from moisture.
Żomm il- flixkun magħluq sew sabiex ikun protett mill- umdità.
Do not remove the desiccant.
Tneħħix id- dessikant.
Printed carton containing one white high density polyethylene (HDPE) bottle.
Kartuna stampata li fiha flixkun wieħed tal- poli- etilin (HDPE) ta ’ lewn bajdani.
The 8 mg, 16 mg and 32 mg tablets are packaged in an HDPE bottle with a child resistant closure, cotton coiler and a desiccant canister.
Il- pilloli ta ’ 8 mg, 16 mg u 32 mg huma ppakkjati fi flixkun HDPE b’ għatu reżistenti għat- tfal, tajjara rrumblata u kunjett b’ dessikant.
The 64 mg tablets are packaged in an HDPE bottle with a child resistant closure, desiccant canister and cotton coiler.
5/ 33 Il- pilloli ta ’ 64 mg huma ppakkjati fi flixkun HDPE b’ għatu reżistenti għat- tfal, kunjett ta ’ dessikant u tajjara rrumblata
5/ 33 Not all pack sizes may be marketed.
Mhux id- daqsijiet kollha tal- pakkett jistgħu qegħdin fis- suq.
Eli Lilly and Company Ltd Priestley Road, Basingstoke Hampshire RG24 9NL United Kingdom
Eli Lilly and Company Ltd Priestley Road, Basingstoke Hampshire RG24 9NL Ir- Renju Unit
6/ 33 ANNEX II
6/ 33 ANNESS II
Eli Lilly and Company Ltd Speke Operations Fleming Road Liverpool L24 9LN UK
Eli Lilly and Company Ltd Speke Operations Fleming Road Liverpool L24 9LN Ir- Renju Unit
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L- AWTORIZZAZZJONI TAL- KUMMERĊ DWAR IL- PROVISTA U L- UŻU
8/ 33 ANNEX III
8/ 33 ANNESS III
10/ 33 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10/ 33 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Outer carton - 8mg
Kartuna ta ’ barra – 8 mg
Reconcile 8 mg chewable tablets for dogs Fluoxetine (as hydrochloride).
8 mg pilloli li tomgħod għal klieb
8 mg fluoxetine (as 9.04 mg fluoxetine hydrochloride)
8 mg fluoxetine 8. 0 mg (bħala 9. 04 mg fluoxetine hydrochloride)
Chewable tablet.
Pillola li tomgħod.
As an aid in the treatment of separation-related disorders in combination with behavioural modification techniques.
Bħala għajnuna fit- trattament ta ’ disturbi relatati ma ’ firda fil- klieb flimkien ma ’ teknika ta ’ modifikazzjoni fl- imġieba.
SPECIAL WARNING(S), IF NECESSARY
TWISSIJIET SPEĊJALI, JEKK NEĊESSARJU
EXP {month/ year} Once opened, use by ….
Jiskadi {xahar/ sena} La darba jinfetaħ uża sa ….
Store in the original container.
Żomm fil- kontenitur oriġinali.
Dispose of waste material in accordance with local requirements.
Armi l- materjal ħażin b’ mod konformi mar- regolamenti lokali.
Eli Lilly and Company Ltd Basingstoke RG24 9NL UK
Eli Lilly and Company Ltd Basingstoke RG24 9NL Ir- Renju Unit
12/ 33 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
12/ 33 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
Bottle label – 8mg
Tikketta tal- flixkun – 8 mg
Reconcile 8 mg chewable tablets for dogs Fluoxetine (as hydrochloride)
Reconcile 8 mg pilloli li tomgħod għal klieb Fluoxetine (bħala ħidroklorid)
8 mg fluoxetine (as 9.04 mg fluoxetine hydrochloride)
8 mg fluoxetine 8. 0 mg (bħala 9. 04 mg Fluoxetine hydrochloride)
EXP {month/ year} Once opened, use by ….
Jiskadi {xahar/ sena} La darba jinfetaħ, uża sa ….
Store in the original container.
Taħżinx f’ temperatura ’ l fuq minn 30oC Żomm fil- kontenitur oriġinali.
14/ 33 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
14/ 33 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Outer carton – 16mg
Kartuna ta ’ barra – 16 mg
Reconcile 16 mg chewable tablets for dogs Fluoxetine (as hydrochloride).
16 mg pilloli li tomgħod għal klieb
16 mg fluoxetine (as 18.08 mg fluoxetine hydrochloride)
16 mg fluoxetine 16. 0 mg (bħala 18. 08 mg fluoxetine hydrochloride)
16/ 33 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
16/ 33 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
Bottle label – 16 mg
Tikketta tal- flixkun – 16 mg
Reconcile 16 mg chewable tablets for dogs Fluoxetine (as hydrochloride)
Reconcile 16 mg pilloli li tomgħod għal klieb Fluoxetine (bħala ħidroklorid)
16 mg fluoxetine (as 18.08 mg fluoxetine hydrochloride)
16 mg fluoxetine 16. 0 mg (bħala 18. 08 mg Fluoxetine hydrochloride)
18/ 33 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
18/ 33 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Outer carton – 32 mg
Kartuna ta ’ barra – 32 mg
Reconcile 32 mg chewable tablets for dogs Fluoxetine (as hydrochloride).
32 mg pilloli li tomgħod għal klieb
32 mg fluoxetine (as 36.16 mg fluoxetine hydrochloride)
32 mg fluoxetine 32. 0 mg (bħala 36. 16 mg fluoxetine hydrochloride)
20/ 33 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
20/ 33 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
Bottle label – 32 mg
Tikketta tal- flixkun – 32 mg
Reconcile 32 mg chewable tablets for dogs Fluoxetine (as hydrochloride)
Reconcile 32 mg pilloli li tomgħod għal klieb Fluoxetine (bħala ħidroklorid)
32 mg fluoxetine (as 36.16 mg fluoxetine hydrochloride)
32 mg fluoxetine 32. 0 mg (bħala 36. 16 mg Fluoxetine hydrochloride)
22/ 33 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
22/ 33 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Outer carton – 64 mg
Kartuna ta ’ barra – 64 mg
Reconcile 64 mg chewable tablets for dogs Fluoxetine (as hydrochloride).
64 mg pilloli li tomgħod għal klieb
64 mg fluoxetine (as 72.34 mg fluoxetine hydrochloride)
64 mg fluoxetine 64. 0 mg (bħala 72. 34 mg fluoxetine hydrochloride)
24/ 33 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
24/ 33 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
Bottle label – 64 mg
Tikketta tal- flixkun – 64 mg
Reconcile 64 mg chewable tablets for dogs Fluoxetine (as hydrochloride)
Reconcile 64 mg pilloli li tomgħod għal klieb Fluoxetine (bħala ħidroklorid)
64 mg fluoxetine (as 72.34 mg fluoxetine hydrochloride)
64 mg fluoxetine 64. 0 mg (bħala 72. 34 mg Fluoxetine hydrochloride)
27/ 33 PACKAGE LEAFLET
27/ 33 FULJETT TA ’ TAGĦRIF FIL- PAKKETT GĦAL
Fluoxetine (as hydrochloride)
Fluoxetine (bħala ħidroklorid)
Reconcile is a speckled tan to brown round chewable tablet containing:
Reconcile hija pillola tonda, imtektka, ta ’ lewn samrani għal kannella, u li tomgħod li fiha:
Reconcile 8 mg fluoxetine (as 9.04 mg fluoxetine hydrochloride) Reconcile 16 mg fluoxetine (as 18.08 mg fluoxetine hydrochloride) Reconcile 32 mg fluoxetine (as 36.16 mg fluoxetine hydrochloride) Reconcile 64 mg fluoxetine (as 72.34 mg fluoxetine hydrochloride)
Reconcile 8 mg fluoxetine 8. 0 mg bħala 9. 04 mg fluoxetine hydrochloride) Reconcile 16 mg fluoxetine 16. 0 mg (bħala 18. 08 mg fluoxetine hydrochloride) Reconcile 32 mg fluoxetine 32. 0 mg (bħala 36. 16 mg fluoxetine hydrochloride) Reconcile 64 mg fluoxetine 64. 0 mg (bħala 72. 34 mg fluoxetine hydrochloride)
Reconcile tablets are used as an aid in the treatment of separation-related disorders in dogs, such as destruction and vocalisation and inappropriate defaecation and/ or urination.
Il- pilloli Reconcile huma użati bħala għajnuna fit- trattament ta ’ disturbi ta ’ meta l- klieb jinfirdu bħal tiġrif u vokalizzazzjoni u ippurgar u tluq t’ awrina fejn mhux xieraq.
This product should only be used in conjunction with a behaviour modification programme recommended by your veterinary surgeon.
Dan il- prodott għandu jintuża biss flimkien ma ’ programm ta ’ modifikazzjoni ta ’ imġieba rakkomandat mit- tabib veterinarju.
Do not use in dogs weighing less than 4 kg.
Tużax fuq klieb li jiżnu inqas minn 4 kg
Do not use Reconcile in dogs with epilepsy or a history of seizures.
Tużax fuq klieb b’ epilessija jew fuq klieb li għandhom storja ta ’ attakki tal- qamar.
28/ 33 This product should not be used in case of hypersensitivity to fluoxetine or other Selective Serotonin Re-uptake Inhibitors (SSRIs).
Dan il- prodott m’ għandux jintuża f’ każijiet ta ’ sensittività eċċessiva magħrufa għal fluoxetine jew Impedituri Silettivi oħra tar- ri- assorbiment ta ’ Serotonin.
- Very common adverse events: decreased appetite (including anorexia); lethargy (including calmness
- Każijiet mhux mixtieqa komuni ħafna: tnaqqis fl- aptit (li jinkludi anoreksja); għejja (li jinkludu
and increased sleeping)
kalmezza u żieda fl- irqad).
- Common adverse events: urinary tract disorders (such as bladder infections, irregular urination,
- Każijiet mhux mixtieqa komuni: disturbi tal- passaġġ ta ’ l- awrina (bħal infezzjonijiet fil- bużżieqa ta ’
discomfort in passing urine); central nervous system signs (incoordination, disorientation)
l- awrina, tmexxija t’ awrina mhux regolari u skumdità meta jgħaddi l- awrina); sinjali fis- sistema nervuża ċentrali (nuqqas ta ’ koordinazzjoni, disorjentazzjoni).
- Uncommon adverse events: weight loss/ loss of condition; dilation of the pupils of the eye
- Każijiet mhux mixtieqa mhux komuni: telf fil- piż/ telf fil- kundizzjoni; twessigħ tal- mimmi ta ’
- Rare adverse events: seizures
- Każijiet mhux mixtieqa rari: attakki tal- qamar.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Jekk tinduna b’ xi effetti serji jew xi effetti oħra li mhumiex imsemmija f’ dan il- fuljett, jekk jogħġbok informa lil veterinarju tiegħek.
Reconcile tablets should be administered orally at a once daily dose of 1 to 2 mg/ kg bodyweight according to the dosage table below:
Il- pilloli Reconcile għandhom jiġu mogħtija mill- ħalq f’ doża 1 sa 2 mg/ kg piż korporali darba kuljum ta ’ skond it- tabella tad- dożaġġi mogħtija hawn isfel:
weight
Piż korporali (kg)
Number of tablets
Numru ta ’ pilloli kuljum
(kg)
4 - 8
Reconcile 8 mg tablet Reconcile 16 mg tablet Reconcile 32 mg tablet Reconcile 64 mg tablet
Reconcile pillola ta ’ 8 mg
The dog’ s response to therapy should be evaluated by the veterinary surgeon.
Reconcile pillola ta ’ 16 mg Reconcile pillola ta ’ 32 mg Reconcile pillola ta ’ 64 mg
Clinical improvement is expected within 1 or 2 weeks.
Ir- rispons tal- kelb għat- terapija għandu jiġi evalwat mit- tabib veterinarju Titjib kliniku hu mistenni fi żmien ġimgħa jew ġimagħtejn.
If no improvement is noted within 4 weeks, consult your veterinary surgeon who will need to re-evaluate the dog’ s treatment.
Jekk l- ebda titjib ma jiġi nnotat fi żmien 4 ġimgħat, ikkonsulta t- tabib veterinarju tiegħek li jkollu bżonn jivvaluta mill- ġdid it- trattament tal- kelb tiegħek.
Professional judgement should be used in monitoring the patient’ s response to therapy to determine the need for continued treatment beyond 8 weeks or discontinuation of treatment should adverse events warrant.
Ġudizzju professjonali għandu jintuża meta wieħed jimmonitorja r- rispons tal- pazjent għal terapija biex jistabilixxi l- bżonn għal trattament kontinwu ’ l hinn minn 8 ġimgħat jew waqfien tat- trattament jekk każijiet mhux mixtieqa jinħtieġu li jsir hekk.
Reconcile tablets may be given with or without food and are flavoured so that most dogs will consume the tablet when offered by the owner.
Il- pilloli Reconcile jistgħu jingħataw ma ’ l- ikel jew fuq stonku vojt u bit- togħma sabiex il- biċċa l - kbira tal- klieb jieħdu l- pillola meta tiġi offruta minn sidhom.
If a dose is missed, the next scheduled dose should be administered as prescribed.
Jekk ma ttieħidx doża, id- doża li jkun imiss għandha tingħata kif preskritta.
Reconcile tablets should be administered orally with or without food.
Il- pilloli Reconcile għandhom jingħataw mill- ħalq ma ’ l- ikel jew fuq stonku vojt.
Dogs should be dosed daily.
Il- klieb għandhom jingħataw il- mediċina kuljum.
Do not store above 30°C.
Taħżinx f' temperaturi ogħla minn 30 oC.
30 days.
30 jum
Discard any tablets remaining in the container after use.
Armi l- pilloli kollha li jibqgħu fir- reċipjent wara l- użu.
Do not use after the expiry date which is stated on the bottle.
Tużax wara d- data ta ’ l- iskadenza fuq il- flixkun.
The safety of Reconcile has not been established in dogs weighing less than 4 kg, or under 6 months of age.
Is- sigurtà ta ’ Reconcile għadha ma ġietx stabilita fi klieb li jiżnu inqas minn 4kg jew huma taħt is- 6 xhur.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician.
F’ każ ta ’ amministrazzjon aċċidentali, fittex parir mediku minnufih u uri l- fuljett ta ’ tagħrif li jinsab fil- pakkett lit- tabib.
In humans, the most common symptoms associated with overdosage include seizures, somnolence, nausea, tachycardia, and vomiting.
Fil- bniedem, l- aktar sintomi komuni assoċjati ma doża eċċessiva jinkludu attakki tal- qamar, ngħas, taqliegħ, takikardja, u remettar.
People with a known hypersensitivity to fluoxetine should avoid contact with the veterinary medicinal product.
Persuni li għandhom sensittività eċċessiva magħrufa għal fluoxetine għandhom jevitaw kull kuntatt mal- prodott mediċinali veterinarju.
Studies to determine the effects of Reconcile tablets on breeding, pregnant or lactating dogs have not been conducted and thus the use in pregnant and lactating dogs is not recommended.
Studji biex jistabilixxu l- effetti ta ’ Reconcile fil- klieb fit- tnissil, it- tqala jew fit- treddigħ ma sarux u għalhekk l- użu tiegħu mhux rakkomandat fi klieb tqal jew li qed ireddgħu.
Reconcile tablets should not be used in dogs with epilepsy or a history of seizures.
Il- pilloli Reconcile m’ għandhomx jintużaw fuq klieb b’ epilessija jew fuq klieb li għandhom storja ta ’ attakki tal- qamar
Please inform your veterinary surgeon if your dog is receiving, or has had, any other medicines, even those not prescribed, as Reconcile tablets should not be given at the same time as many other medicines.
Jekk jogħġbok informa lit- tabib veterinarju tiegħek jekk il- kelb tiegħek qed jieħu, jew ħa mediċini oħra, anke dawk mhux mogħtija b’ riċetta, peress li Reconcile m’ għandux jingħata fl- istess ħin ta ’ ħafna mediċini oħra.
Further advice for the veterinary surgeon - see section 4.8 of the Summary of Product Characteristics for further information on interactions with other medicinal products.
Rakkomandazzjonijiet oħra lit- tabib veterinarju - ara sezzjoni 4. 8 tal- Karatteristiċi tal- Prodott fil- Qosor għal aktar tagħrif fuq effetti oħra li jista ’ jkollu ma ’ mediċini oħra.
In cases of accidental overdose your veterinary surgeon should be consulted immediately and symptomatic therapy should be initiated.
F’ każ ta ’ doża eċċessiva aċċidentali, t- tabib veterinarju għandu jiġi konsultat immedjatament u terapija sintomatika għandha tiġi mibdija.
(For further information see section 4.10 of the Summary of Product Characteristics).
(Għal aktar informazzjoni ara sezzjoni 4. 10 tal- Karatteristiċi tal - Prodott fil- Qosor).
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull prodott li ma ġiex użat jew materjal ħażin ieħor, għandu jintrema skond kif jitolbu r- regolamenti lokali.
Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jiġu mormija ma ’ l- ilma ħażin jew ma ’ l- iskart domestiku.
The tablets are packaged in HDPE bottles, each bottle containing 30 tablets with a cotton coiler and desiccant canister.
Il- pilloli huma ppakkjati fi flixkun HDPE kull flixkun fih 30 pillola, tajjara rrumblata u kunjett bid- dessikant.
Κύπρος Eli Lilly Regional Operations GmbH Elanco Animal Health Kölblgasse 8-10 A-1030 Wien Tel.: +43 1 71178-0
32/ 33 Κύπρος Eli Lilly Regional Operations GmbH Elanco Animal Health Kölblgasse 8- 10 A- 1030 Wien Tel.: +43 1 71178- 0
What is Rheumocam?
X' inhu Rheumocam?
Rheumocam is a yellowish opaque oral suspension which is to be given mixed with food.
Rheumocam huwa sospensjoni orali ta ’ kulur opak abjad jagħti fl- isfar li għandha tingħata mħallta ma ’ l- ikel.
Rheumocam contains the active substance meloxicam in a strength of 1.5 mg/ ml.
Rheumocam fih is- sustanza attiva meloxicam bis- saħħa ta ’ 1. 5 mg/ ml.
Rheumocam is a ‘ generic ’ which means that Rheumocam is similar to a ‘ reference veterinary medicine ’ already authorised in the EU (Metacam 1.5 mg/ ml oral suspension).
Rheumocam hija ‘ ġenerika ’ li tfisser li Rheumocam hija simili għal ‘ mediċina veterinarja ta ’ referenza ’ li hija awtorizzata diġa ’ fl- UE (Metacam 1. 5 mg/ ml sostensjoni orali).
Studies have been carried out to prove that Rheumocam is ‘ bioequivalent ’ to the reference veterinary medicine which means that Rheumocam 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 Rheumocam huwa ‘ bijoekwivalenti ’ għal mediċina veterinarja ta ’ referenza li tfisser li Rheumocam hija ekwivalenti għal Metacam 1. 5 mg/ ml sospensjoni bil- mod li huwa assorbit u wżat mill- ġosem.
What is Rheumocam used for?
Għal x' hiex jintuża Rheumocam?
Rheumocam is used in dogs to relieve inflammation and pain in musculo-skeletal disorders.
Rheomocam jintuża fil- klieb sabiex titnaqqas l- infjammazzjoni u l- uġigħ fil- problemi muskuloskeletali.
It can be used for both acute disorders, such as those seen after an injury, and chronic (long term) disorders.
Jista ’ jintuża kemm biex tikkura problema akuti, bħal dawk li jidhru wara li jkunu weġġgħu, u problemi kroniċi (fit- tul).
Rheumocam is given to the dog once a day, with food, at the dose of 0.2 mg meloxicam/ kg body weight on the first day, then at 0.1 mg/ kg afterwards.
Rheumocam jingħata lill- kelb darba kuljum, flimkien ma ’ l- ikel, f’ doża ta ’ 0. 2mg meloxicam/ kg piż tal- ġisem fl- ewwel jum, u b’ doża ta ’ 0. 1mg/ kg għall- ġranet ta ’ wara.
The amount of suspension to be used is measured using a special dosing syringe (provided in the product package) and poured on the food.
L- ammont ta ’ sospensjoni li għandha tintuża hija mkejjla billi tintuża siringa speċjali għad - dożaġġ (li hija provduta fil- pakkett), u mitfugħa fl- ikel.
How does Rheumocam work?
Kif jaħdem Rheumocam?
Rheumocam contains meloxicam, which belongs to a class of medicines called non-steroidal anti- inflammatory drugs (NSAIDs).
Rheumocam fih meloxicam li jagħmel parti minn klassi ta ’ mediċini msejjħa mediċini anti - infjammatorji mhux sterojdi (NSAIDs).
Meloxicam acts by inhibition of prostaglandin synthesis.
Meloxicam jaġixxi billi jinibixxi s- sinteżi tal- prostglandini.
How has the effectiveness of Rheumocam been studied?
Kif ġiet studjata l- effikaċja ta ’ Rheumocam?
A study looked at how Rheumocam was absorbed and its effects in the body, in comparison with Metacam 1.5 mg/ ml oral suspension.
Sar studju li ħares lejn kif Rheumocam ġie assorbit u l- effetti tiegħu fil- ġisem, meta mqabbla ma ’ 1. 5mg/ ml ta ’ sospensjoni orali Metacam.
Reproduction is authorised provided the source is acknowledged What are the side-effects of Rheumocam?
Reproduction is authorised provided the source is acknowledged X’ inhuma l- effetti sekondarji ta ’ Meloxivet?
Occasional side effects of Rheumocam are those seen with NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools and apathy (lack of vitality).
Effetti sekondarji okkażjonali ta ’ Rheumocam huma dawk li jidhru bil- NSAIDs, bħat- telf ta ’ aptit, rimetter, dijarrea, demm fil- qlalet 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 temporarji u jisparixxu ladarba t- tratatment jiġi mwaqqaf.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
X’ inhuma l- prekawzjonijiet li għandha tieħu persuna li tagħti l- mediċina jew li tiġi f’ kuntatt ma ’ l- annimal?
People who are hypersensitive (allergic) to NSAIDs should avoid contact with Rheumocam.
Il- persuni li huma ipersensittivi (allerġiċi) għall- NSAIDs għandhom jevitaw il- kuntatt ma ’ Rheumocam.
Why has Rheumocam been approved?
Għaliex ġie approvat Rheumocam?
The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Rheumocam has been shown to be bioequivalent to Metacam 1.5 mg/ ml oral suspension.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkunsidra li, skond ir- rekwiżiti ta ’ l- Unjoni Ewropea, Rheumocam kien jidher bħala bijoekwivalenti għal Metacam 1. 5mg/ ml ta ’ sospensjoni orali.
Therefore the CVMP’ s view was that, as for Metacam 1.5 mg/ ml oral suspension, Rheumocam’ s benefits are greater than its risks when treating inflammation or pain in muscles or joints in dogs and they recommended that Rheumocam 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 ’ Rheumocam huma akbar mir- riskji tiegħu meta tiġi trattata l - infjammazzjoni jew uġigħ fil- muskoli jew fil- ġogi fil- klieb u rrakomandaw li Rheumocam għandu jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Rheumocam:
Tagħrif ieħor dwar Rheumocam:
The European Commission granted a marketing authorisation valid throughout the European Union, for Rheumocam to Chanelle Pharmaceuticals Manufacturing Ltd. on 10.01.2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Rheumocam valida fl- Unjoni Ewropea kollha lil Chanelle Pharmaceuticals Manufacturing Ltd.. Fl - 10. 01. 2008.
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.
10.01.2008
Dan is- sommarju ġie aġġornat l- aħħar fil -. 10. 01. 2008
Pharmaceutical Target species Form
Speċi li fuqhom għandu jintuża l- prodott
Route of administration
Mod ta ’ Ammini strazzjoni
PET bottle polypropylene measuring syringe
Flixkun tal- PET siringa tad - dożaġġ polypropylene ta ’ lewn safrani.
1 bottle with N/ A dosing syringe
flixkun 1 b’ siringa tad - dożaġġ
HDPE bottle polypropylene measuring syringe
Flixkun ta ’ ’ densità għolja ta ’ polietelina, siringa tad - dożaġġ polypropylene ta ’ lewn safrani.
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
KARATTERISTIĊI TAL- PRODOTT FIL- QOSOR
Rheumocam 1.5 mg/ ml oral suspension for dogs
Rheumocam 1. 5 mg/ ml Suspensjoni orali għall- klieb
Each ml of Rheumocam 1.5 mg/ ml oral suspension contains:
Kull ml ta ’ Rheumocam 1. 5 mg/ ml suspensjoni orali fih:
Meloxicam 1.5 mg
Meloxicam 1. 5 mg
Excipient:
Sustanza( i) mhux attiva( i):
Sodium benzoate 5 mg
Sodium benzoate 5 mg
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Għas- serħan mill- infjammazzjoni u uġigħ akut kif ukoll kroniku f ’ disturbi muskolu- skeletriċi.
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 w’ emorraġija, li għandhom indeboliment fil- funzjoni epatika, kardijaka jew renali, u f’ disturbi emorraġiċi.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Tużax f’ każ ta ’ sensittività eċċessiva għas- sustanza attiva jew għal kwalunkwe sustanza mhux attivi.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Jekk ikun hemm reazzjonijiet mhux mixtieqa, t- trattament għandu jitwaqqaf u għandu jittieħed il- parir ta ’ veterinarju.
2 Special precautions to be taken by the person administering the veterinary medicinal product to animals
2 Evita l- użu fi kwalunkwe annimal li jkun deidratat, ipovolaemiku jew ipotensiv, għax hemm riskju potenzjali ta ’ żieda ta’ tossiċità renali.
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 malprodott mediċinali veterinarju.
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood and apathy have occasionally been reported.
Reazzjonijiet avversi tipiċi NSAIDs bħal nuqqas t’ aptit, rimettar, dijarea, demm moħbi fl- ippurgar u apatija, kienu rrappurati xi kultant.
These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
Dawn l- effetti sekondarji ġeneralment iseħħu fi żmien l- ewwel ġimgħa tat- trattament, u f’ ħafna każijiet jgħaddu malajr u jiefqu wara t- tmiem tat- trattament, iżda f’ każijiet rari ħafna, jistgħu jkunu serji jew fatali.
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects.
NSAIDs oħra, dijuretiċi, antikoagulanti, antibijotiċi aminoglycoside u sustanzi oħra li jeħlu ħafna malproteini, jistgħu jikkompetu għat- twaħħil u b’ hekk iwasslu għal effetti tossiċi.
Rheumocam must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Rheumocam m’ għandux jingħata flimkien ma ’ NSAIDs oħra 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 bi prodotti mediċinali veterinarji bħal dawn, qabel ma jibda t- trattament.
The treatment-free period, however, should take into account the pharmacokinetic properties of the veterinary products used previously.
Il- perjodu mingħajr trattament, madankollu, irid jikkunsidra l- karatteristiċi farmakoloġiċi tal- prodotti veterinarji użati qabel.
To be administered mixed with food.
Għandu jingħata mħallat ma ’ l- ikel.
Initial treatment is a single dose of 0.2 mg meloxicam/ kg body weight on the first day.
It- trattament tal- bidu jikkonsisti minn doża waħda ta ’ 0. 2 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem flewwel 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 body weight.
It- trattament għandu jitkompla darba kuljum bl- għoti orali (f’ intervalli ta ’ 24 siegħa) biddoża tal - manteniment ta ’ 0. 1 mg meloxicam / kg ta ’ piż tal- ġisem.
The syringe fits onto the bottle and has a kg-body weight scale which corresponds to the maintenance dose (i. e.
Is- suspensjoni tista ’ tingħata permezz tas- siringa tal- kejl ta ’ Rheumocam ipprovduta fil- pakkett Is- siringa teħel mal- flixkun u għandha skala ta ’ kilogramm- piż tal- ġisem li tikkorrispondi mad- doża tal - manteniment.
Thus for the first day, twice the maintenance volume will be required.
Għalhekk, għall- bidu tat- terapija fl- ewwel jum, id- doppju tal- volum tal- manteniment ser ikun meħtieġ.
Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.
Rispons kliniku ġeneralment ikun osservat matul l- ewwl 3- 4 ijiem. It- trattament għandu jitwaqqaf wara perjodu massimu ta ’ 10 ijiem, jekk l- ebda titjib kliniku ma jkun evidenti.
4.11 Withdrawal period
3 4. 11 Perjodu ta ’ żamma
Anti-inflammatory and Anti-rheumatic products, Non-steroids ATC vet code:
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 sterojdika (NSAID) tal- klassi oxicam li taġixxi blinibizzjoni tas- sintesi ta ’ prostaglandin, u b’ hekk teżerċita effetti anti- infjammatorji, analġesiċi, kontra t - tnixxija u antipiretiċi.
In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
Studji in vitro u in vivo urew li Meloxicam jinibixxi cyclooxygenase- 2 (COX- 2) b’ mod iktar qawwi minn cyclooxygenase- 1 (COX- 1).
Absorption Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are obtained after approximately 7.5 hours.
Assorbiment Meloxicam huwa kompletament assorbit wara li jingħata mill- ħalq u l- ogħla konċentrazzjonijiet filplażma jinkisbu wara madwar 7. 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 skond il- kors rakkomandat taddożaġġ, il - konċentrazzjonijiet fl- istat fiss ta ’ meloxicam fil- plażma jintlaħqu fit- tieni jum tattrattament.
Distribution There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range.
Distribuzzjoni Hemm relazzjoni lineari bejn id- doża mogħtija u l- konċentrazzjoni fil- plażma osservata fil- firxa taddoża terapewtika.
The volume of distribution is 0.3 l/ kg.
Il- volum taddistribuzzjoni 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.
Metaboliżmu Il- biċċa l- kbira ta ’ meloxicam jinsab fil- plażma u hu wkoll prodott ewlieni tat- tneħħija biljari, filwaqt li l - awrina fiha biss traċċi tal- kompost prinċipali.
Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites.
Meloxicam huwa metabolizzat għal alkoħol, derivattiv ta ’ l - aċidu u għal diversi metaboliti polari.
Approximately 75% of the administered dose is eliminated via faeces and the remainder via urine.
Madwar 75% tad- doża li tingħata titneħħa flippurgar, u l - bqija fl- awrina.
Saccharin Sodium Sodium Carboxyl Methyl Cellulose Colloidal Silicon Dioxide Citric Acid Monohydrate Sorbitol Solution Disodium Hydrogen-Phosphate Dodecahydrate Sodium Benzoate Honey Flavour.
Saccharin Sodium Sodium Carboxyl Methyl Cellulose Colloidal Silicon Dioxide Citric Acid Monohydrate Sorbitol Solution Disodium Hydrogen- Phosphate Dodecahydrate Sodium Benzoate
6.2 Incompatibilities
4 Essenza tal- għasel
2 years Shelf life after first opening the immediate packaging:
6. 2 Inkompatibilitajiet
6.4 Special precautions for storage
6. 5 In- natura u l- għamla ta ’ l- ewwel ippakkjar
42, 100 or 200 ml polyethylene terephthalate (PET) bottle with a tamper resistant child proof closure, and a 15 ml HDPE bottle with a tamper resistant child proof closure, and a polypropylene measuring syringe.
Flixkun tal- polyethylene terephthalate tat- 42, 100 jew 200 ml b’ qattara tal- polyethylene, tapp li jirreżisti l - ftuħ mittfal, u flixkun ta ’ 15 ml b’ densità għolja ta ’ polietelina, tapp li jirreżisti l- ftuħ mittfal, u siringa tal - kejl tal- polypropylene.
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 tkunx ġiet użata jew materjali ta ’ skart prodotti minn din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
MARKETING AUTHORISATION HOLDER
ID L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Galway, Ireland.
Galway, L- Irlanda.
Tel: + 353 91 841788 Fax: + 353 91 842937 e-mail: sales@chanellegroup. ie
Tel: + 353 91 841788 Fax: + 353 91 842937 e- mail: sales@ chanellegroup. ie
MARKETING AUTHORISATION NUMBERS
UMRI TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
5 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 tinsab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu.
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IS- SID TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ LAWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ FUQ IL- PROVVISTA JEW L- UŻU
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ LAWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ DWAR L- UŻU SIGUR U EFFETTIV
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL TAL- LOTT
Galway, IRELAND.
Galway, L- IRLANDA.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI ĦATTQEGĦID FIS- SUQ 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 TA ’ L- AWTORIZZAZZJONI GĦATTQEGĦID FIS- SUQ DWAR L- UŻU SIGUR U EFFETTIV
{Carton for 15 ml, 42 ml, 100 ml or 200 ml bottle}
{Kartuna għal fliexken 15 ml, 42 ml, 100 ml jew 200 ml}
Rheumocam 1.5 mg/ ml oral suspension for dogs
Rheumocam 1. 5 mg/ ml suspensjoni orali għall- klieb.
1.5 mg of meloxicam 5 mg of sodium benzoate
1. 5 mg ta ’ meloxicam 5 mg ta ’ sodium benzoate
TARGET SPECIES
SPEĊI FIL- MIRA
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Allevazzjoni ta ’ l- infjammazzjoni u ta ’ l- uġigħ f’ disturbi muskolu- skeletali akut u kroniku.
To be administered mixed with food.
Li għandu jingħata mħallat ma ’ l- ikel.
WITHDRAWAL PERIOD
PERJODU TA ’ ŻAMMA
Do not use in pregnant or lactating animals.
Tużax fuq annimali tqal jew li qegħdin ireddgħu.
EXP {month/ year} Once opened use within 6 months.
Jiskadi {xahar/ sena} Ladarba miftuħ uża fi żmien 6 xhur.
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
To be supplied only on veterinary prescription.
Għandu jingħata biss b’ riċetta veterinarja
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
L- ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TALKUMMERĊ
12 BN{number}
Lott {numru}
13 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
13 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
{Label for 100ml and 200ml bottles}
{Tikketta għal fliexken ta ’ 100ml u 200ml}
Rheumocam 1.5 mg/ ml oral suspension for dogs
Rheumocam 1. 5 mg/ ml suspensjoni orali għall- klieb
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Allevjazzjoni ta ’ l- infjammazzjoni u ta ’ l- uġigħ f’ disturbi muskolu- skeletali akut u kroniku.
Avoid introduction of contamination during use.
Evita l- introduzzjoni tal- kontaminazzjoni matul l- użu.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA ’ PRODOTTI MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI, jekk ikun il- każ
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
L- ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI GĦAT FISSUQ
MARKETING AUTHORISATION NUMBER(S)
NUMRU TA ’ L- AWTORIZZAZZJONIJIET GĦAT- TQEGĦID FIS- SUQ
BN{number}
Lott {numru}
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
16 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
{Label for 15ml and 42 ml bottle}
{Tikketta għal fliexken ta ’ 15 ml jew 42 ml}
To be administered mixed with food.
Jingħata ma l- ikel.
WITHDRAWAL PERIOD
ŻMIEN TA ’ ŻAMMA
BN {number}
Lott{ numru}
EXP {month/ year} Once opened use within 6 months.
Jiskadi {xahar/ sena} La darba jinfetaħ uża fi żmien 6 xhur.
17 PACKAGE LEAFLET FOR:
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 GĦAT- TQEGĦID FISSUQ U TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT, JEKK IKUNU DIFFERENTI
Do not use in dogs less than 6 weeks of age.
KONTRA- INDIKAZZJONIJIET
These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
Fil- klieb, dawn l- effetti sekondarji ġeneralment iseħħu fi żmien lewwel ġimgħa tat- trattament, u f’ ħafna każijiet jgħaddu malajr u jisparixxu wara t- tmiem tattrattament, iżda f’ każijiet rari ħafna, jistgħu jkunu serji jew fatali.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Jekk tinnota xi effetti serji jew effetti oħra mhux imsemmija f’ dan il- fuljett, jekk jogħġbok informa littabib veterinarju tiegħek.
Dogs.
19 Klieb
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
DOŻA GĦAL KULL SPEĊI, MOD( I) U METODU TA ’ AMMINISTRAZZJONI Dożaġġ
To be administered mixed with food.
Li għandu jingħata ma ’ l- ikel.
Avoid introduction of contamination during use.
Evita l- introduzzjoni tal- kontaminazzjoni waqt l- użu.
The suspension can be given using the measuring syringe provided in the package.
Is- suspensjoni tista ’ tingħata permezz tas- siringa tal- kejl ta ’ Rheumocam ipprovduta fil- pakkett.
The syringe has a scale which corresponds to the volume required.
Issiringa għandha skala li tikkorrespondi għall- volum meħtieġ.
The following dosing table indicates what volume to administer depending on the weight of the dog:
It- tabella tad- dożaġġ li ġejja tindika liema volum għandu jingħata jiddependi mill- piż tal- kelb:
Bodyweight (kg) 7.5 15 22.5 30 37.5 45 52.5 60
Piż tal- ġisem (kg) 7. 5 15 22. 5 30 37. 5 45 52. 5 60
Maintenance Dosage (ml) 0.5 1 1.5 2 2.5 3 3.5 4
Doża tal- manteniment (ml) 0. 5 1 1. 5 2 2. 5 3 3. 5 4
For the first day, twice the maintenance dosage will be required.
Għall- ewwel jum, ikun meħtieġ id- doppju tad- doża ta ’ manteniment.
A clinical response is normally seen within 3 to 4 days.
Rispons kliniku ġeneralment ikun osservat wara 3- 4 ijiem.
Please carefully follow the instructions of the veterinarian.
Jekk jogħġbok segwi blattenzjoni l- istruzzjonijiet tal- veterinarju.
19 If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought.
20 Jekk ikun hemm reazzjonijiet mhux mixtieqa, it- trattament għandu jitwaqqaf u għandu jittieħed ilparir 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, ipovolaemiku jew ipotensiv, għax hemm riskju potenzjali ta ’ żieda ta’ tossiċità renali.
Rheumocam must not be administered in conjunction with other NSAIDs or glucocorticosteriods.
Rheumocam m’ għandux jingħata flimkien ma ’ NSAIDs oħrajn jew ma ’ glucocorticosteriods.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary 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 veterinarji bħal dawn, qabel ma jibda t- trattament.
The treatment-free period, however, should take into account the pharmacokinetic properties of the veterinary products used previously.
Fil- perjodu mingħajr trattament, madankollu, għandu jkun ikkunsidrat il- karatteristiċi farmakoloġiċi tal- prodotti użati qabel.
In case of accidental ingestion, seek medical advice immediately and show this package leaflet or the label to the physician.
F’ każ li tibla ’ l- prodott b’ mod aċċidentali, fittex tabib mal- ewwel u qis li turih il- pakkett jew il- fuljett ta ’ informazzjoni li jkun fih ġewwa.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA ’ PRODOTTI MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
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 użati jew materjali ta ’ skart prodotti minn din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
To be supplied only on veterinary prescription.
Li għandu jingħata biss b’ riċetta ta ’ tabib.
15, 42, 100 or 200 ml bottle with a measuring syringe.
Flixkun ta ’ 15, 42, 100 jew 200 ml b’ siringa ta ’ kejl.
Not all pack sizes may be marketed.
Mhux il- qisien tal- pakketti kollha jistgħu jkunu mqiegħda fis- suq.
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- valutazzjoni mwettqa mill- Kumitat għal Prodotti Mediċinali għal Użu Veterinarju (CVMP) fuq il- bażi tad- dokumentazzjoni pprovduta, wasslet għar- rakkomandazzjonijiet dwar il- kundizzjonijiet ta ’ l- użu.
This document cannot replace a face-to-face discussion with your veterinarian.
Dan id- dokument ma jistax jieħu post diskuzzjoni wiċċ imb’ wiċċ mal- veterinarju tiegħek.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Jekk inti teħtieġ aktar informazzjoni dwar il- kondizzjoni medika jew dwar it- trattament ta ’ l- annimal tiegħek, ikkuntattja lill- veterinarju tiegħek.
What is SevoFlo?
X’ inhu SevoFlo?
SevoFlo is 100% sevoflurane, a chemical which is a liquid at room temperature, but, when heated, becomes a gas (vaporises).
SevoFlo huwa 100% sevoflurane, kimika likwida f’ temperatura ambjentali, imma, li meta jissaħħan isir gass (tivvaporizza).
This gas is used as a general anaesthetic for dogs.
Dan il- gass jintuża bħala loppju ġenerali fil- klieb.
What is SevoFlo used for?
Għalxiex jintuża SevoFlo?
SevoFlo is used both to induce and maintain anaesthesia in dogs.
SevoFlo jintuża biex jinduċi u jżomm l- anestesija fil- klieb.
SevoFlo is administered using specialised anaesthetic equipment, usually in a carefully controlled gas mixture including oxygen.
SevoFlo jingħata b’ tagħmir ta ’ l- anestesija speċjalizzat, ġeneralment f’ taħlita ta ’ gassijiet ikkontrollata b’ reqqa li tinkludi l- ossiġnu.
The dog breathes in the gas mixture, which causes it to become unconscious.
Il- kelb jieħu n- nifs fit- taħlita tal- gass, li titilfu minn sensih.
How does SevoFlo work?
Kif jaħdem SevoFlo?
When a dog is given a mixture of oxygen and sevoflurane to breathe, the sevoflurane is inhaled into its lungs, from where it goes into the blood stream, crosses into the brain and induces an unconscious state.
Meta kelb jingħata taħlita ta ’ ossiġenu u sevoflurane biex jieħu n- nifs minnha, sevoflurane jittieħed man- nifs u jidħol fil- pulmun, minn fejn jidħol fiċ- ċirkolazzjoni tad- demm, jaqsam għall- moħħ u jinduċi stat ta ’ telfien mis- sensi.
At the end of surgery, the anaesthetic is discontinued.
Fi tmiem l- intervent kirurġiku, il- loppju jitwaqqaf.
When the concentration of anaesthetic in the brain drops below a certain level the dog wakes up.
Meta l- konċentrazzjoni tal- loppju fil- moħħ taqa ’ taħt ċertu livell, il- kelb iqum.
How has SevoFlo been studied?
Kif ġie studjat SevoFlo?