qanastek/EMEA-V3 huggingface dataset:
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Eħles mill- materjal għar- rimi billi tgħalli fil- misħun, taħraq jew tgħarraq ġo diżinfettant approppjat approvat mill- Awtorita Kompetenti tal- pajjiż.
9/ 17 PARTICULARS TO APPEAR ON THE OUTER PACKAGE {NATURE/ TYPE}
9/ 17 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
FHV (F2 strain)................................................................................................................ ≥ 104.9 CCID50 FCV (431 and G1 strains).............................................................................................. ≥ 2.0 ELISA U.
FHV (strejn F2).............................................................................................................. ≥ 104. 9 CCID501 FCV (strejn 431 u G1)..................................................................................................... ≥ 2. 0 ELISA U.
Gentamicin, at most......................................................................................................................
Gentamiċin, massimu ta ’...............................................................................................................
EU/ 2/ 04/ 051/ 001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/ 2/ 04/ 051/ 002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
EU/ 2/ 04/ 051/ 001 Lajofiliżejt (10 fliexken ta ’ doża) + solvent (10 fliexken ta ’ doża) EU/ 2/ 04/ 051/ 002 Lajofiliżejt (50 flixkun ta ’ doża) + solvent (50 flixkun ta ’ doża)
Purevax RC lyophilisate for injection
Purevax RC lajofiliżejt għall- injezzjoni.
Read the package leaflet before use
Aqra l- fuljett ta 'tagħrif qabel tuża.
Purevax RC solvent
Purevax RC solvent
Marketing authorisation holder MERIAL 29, avenue Tony Garnier F-69007 Lyon France
Sid l- Awtorizzazzjoni tal- Kummerċ MERIAL 29, avenue Tony Garnier F- 69007 Lyon France
Manufacturing authorisation holder responsible for batch release MERIAL Laboratoire Porte des Alpes Rue de l'Aviation F-69800 Saint Priest France
Manifattur li jħalli l- konsenja tmur fis- suq MERIAL Laboratoire Porte des Alpes Rue de l’ Aviation F- 69800 Saint Priest France
Purevax RC Lyophilisate and solvent for suspension for injection.
Purevax RC Lajofiliżejt u solvent għal suspensjoni għall- injezzjoni.
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain)..................................... ≥ 104.9 CCID501 Inactivated feline Calicivirosis antigens (FCV 431 and FCV G1 strains).................... ≥ 2.0 ELISA U.
Herpesvajrus attenwat tar- rinotrakeite fil- qtates (FHV strejn F2)................................... ≥ 104. 9 CCID501 Antiġeni inattivati tal- Kaliċivirosi fil- qtates (strejn FCV 431 u G1).............................. ≥ 2. 0 ELISA U.
1 ml 1: cell culture infective dose 50%
Ilma għall- injezzjoni%............................................................................................................................................. q. s. ml 1: doża infettiva tas- cell culture 50
- against calicivirus infection to reduce clinical signs and excretion.
- kontra l- infezzjoni tal- kaliċivirus biex tnaqqas sinjali kliniċi u eskrezzjoni,
Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis and calicivirus components.
Ġie muri li l- bidu ta ’ l- immunità jseħħ ġimgħa wara l- ewwel kors ta ’ vaċċinazzjoni għall - komponenti tar- rinotrakeite u kaliċivirus.
Inject by subcutaneous route one 1-ml dose of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination scheme:
Injetta taħt il- ġilda doża ta ’ ml ta ’ vaċċin wara li jiġi rikostitwit il- lajofiliżejt mas- solvent, skond din l- iskema li ġejja ta ’ tilqim:
Do not mix with any other vaccine or immunological product, except those mentioned below.
Tħallatx ma xi vaċċin jew prodott immunoloġiku ieħor, ħlief dawk imsemmija hawn taħt.
What is Quadrisol?
X’ inhu Quadrisol?
Quadrisol is an oral gel presented in graduated multidose oral syringes that contain the active substance vedaprofen as 100 mg/ ml (for horses).
Quadrisol hu ġell orali ppreżentat f’ siringi orali bil- marki tal- kejl għal ħafna dożi li fihom is - sustanza attiva vedaprofen f’ konċentrazzjoni ta ’ 100 mg/ ml (għaż- żwiemel).
What is Quadrisol used for?
Għal xiex jintuża Quadrisol?
Quadrisol is a pain killer (an anti-inflammatory and analgesic) used in horses.
Quadrisol hu mediċina għal kontra l- uġigħ (mediċina anti- infjammatorja u analġeżika) użata fiż- żwiemel.
In horses, Quadrisol 100 mg/ ml oral gel is used to relieve pain and reduce inflammation due to problems with and injury to the muscles, bones and joints and also injuries to other non-bony areas of the body(so called soft tissue lesions) including the trauma caused by surgery.
Fiż- żwiemel, il- ġell tal- Quadrisol tal- 100 mg/ ml jintuża għas- serħan mill- uġigħ u t- tnaqqis ta ’ l- infjammazzjoni minħabba problemi u ġrieħi fil- muskoli, l- għadam u l- ġogi kif ukoll ġrieħi lil postijiet oħra mingħajr għadam (magħrufa bħala leżjonijiet tat- tessuti rotob) inkluż it - trawma kkawżata mill- kirurġija.
The oral gel can be given 3 hours or earlier before a surgical operation.
Il- ġell orali jista ’ jingħata tliet sigħat jew anki iktar qabel ma tibda l- operazzjoni.
The dose, frequency, route, and length of treatment depends on the weight and type of animal and the condition to be treated.
Id- doża, il- frekwenza, il- mod kif tingħata u t- tul tat- trattament jiddependu fuq il- piż u t- tip ta ’ annimal u l- kundizzjoni li tkun qed tiġi ttrattata.
For details, please see the Package Leaflet.
Għal iktar dettalji, jekk jogħġbok ara l- Fuljett ta ’ Tagħrif.
How does Quadrisol work?
Kif jaħdem Quadrisol?
Quadrisol contains vedaprofen, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Quadrisol fih vedaprofen, li jagħmel parti minn klassi ta ’ mediċini magħrufa bħala mediċini anti- infjammatorji mhux sterojdi (NSAIDs).
Vedaprofen blocks an enzyme (cyclo-oxygenase) that is involved in the production of prostaglandins.
Vedaprofen jimblokka enzim (cyclo- oxygenase) li għandu x’ jaqsam mal- produzzjoni ta ’ prostaglandins.
Prostaglandins are substances that trigger pain, swelling and inflammation, and the action of Quadrisol reduces these responses.
Il- prostaglandins huma sustanzi li jistimulaw l- uġigħ, l- infiħ u l- infjammazzjoni, u l- azzjoni ta ’ Quadrisol tnaqqas dawn ir - risponsi.
What benefit has Quadrisol shown during the studies?
Kif ġie studjat Quadrisol?
Quadrisol oral gel improved the clinical scores for lameness and soft tissue injuries in horses.
L- effikaċja ta ’ Quadrisol tqabblet ma ’ dik ta ’ prodott ieħor simili.
The response to treatment with Quadrisol was similar to the response to the other similar product.
X’ inhu l- benefiċċju ta ’ Quadrisol li ntwera f’ dawn l- istudji?
What are the side effects of Quadrisol?
X’ inhuma l- effetti sekondarji ta ’ Quadrisol?
The side effects of Quadrisol are typical for those seen with other medicines from this product class (NSAIDs) such as damage to (lesions) the mouth, stomach, intestines (including soft stools or diarrhea) and the kidneys or lethargy.
L- effetti sekondarji ta ’ Quadrisol huma tipiċi għal dawk li dehru ma ’ mediċini oħra f’ din il - klassi (NSAIDs) bħal ħsara (leżjonijiet) fil- ħalq, fl- istonku, fl- imsaren (inkluż ippurgar merħi u dijarea) u fil- kliewi jew letarġija.
In horses, skin rashes (urticaria) have been reported.
Fiż- żwiemel, ġieli kien hemm raxx (urtikarja).
All of these effects are reversible.
Dawn l - effetti huma kollha reversibbli.
Quadrisol must not be administered in conjunction with other drugs that work in the same way (NSAIDs) or with other anti-inflammatory drugs such as the glucocorticosteroids.
Quadrisol m’ għandux jingħata flimkien ma ’ mediċini oħra li jaħdmu bl- istess mod (NSAIDs) jew ma ’ mediċini anti- infjammatorji oħra bħall- glucocorticosteroids.
Horses intended for racing and competition should be treated according to local requirements and appropriate precautions must be taken to ensure compliance with the official competition regulations.
Iż- żwiemel li jkunu se jieħdu sehem f’ tiġrijiet u kompetizzjonijiet għandhom jiġu ttrattati skond ir- rekwiżiti lokali u għandhom jittieħdu l- prekawzjonijiet xierqa biex tkun żgurata l - konformità mar- regolamenti uffiċjali tal- kompetizzjoni.
In case of doubt, it is advisable to test the urine.
F’ każ ta ’ dubju, huwa rakkomandat li tiġi ttestjata l- awrina.
Quadrisol has been developed especially for horses and is not intended for use in humans.
Quadrisol ġie żviluppat b’ mod speċjali għall- klieb u ż- żwiemel u m’ għandux jintuża fuq il - bniedem.
What is the time to allow before a horse can be slaughtered and the meat used for human consumption (withdrawal period)?
Kemm irid jgħaddi ħin qabel ma żiemel ikun jista ’ jinqatel biex il- laħam tiegħu jiġi kkunsmat mill- bniedem (withdrawal period)?
After the last day of treatment with Quadrisol, horses should not be slaughtered for 12 days.
Wara l- aħħar jum tat- trattament b’ Quadrisol, iż- żwiemel m’ għandhomx jinqatlu fit- 12- il jum ta ’ wara.
The use of Quadrisol is not permitted in horses producing milk that is intended for human consumption.
L- użu ta ’ Quadrisol mhuwiex permess fi żwiemel li jkunu qed jipproduċu ħalib li jista ’ jintuża għall- konsum mill- bniedem.
Why has Quadrisol been approved?
©EMEA 2009 Għaliex ġie approvat Quadrisol?
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Quadrisol to reduce of inflammation and relieve pain caused by musculoskeletal disorders and trauma are greater than any risks associated with this treatment.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) qabel li l- benefiċċji ta ’ Quadrisol fit- tnaqqis ta ’ l- infjammazzjoni u s- serħan mill- uġigħ ikkawżat minn problemi muskoloskeletali u minn trawma huma ikbar minn kwalukwe riskju assoċjat ma ’ dan it - trattament.
CVMP recommended that Quadrisol should be given a marketing authorisation.
Is- CVMP irrakkomanda li Quadrisol jingħata l- awtorizzazzjoni għat- tqegħid fis - suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ bejn il- benefiċċji u r- riskji jinsab fil- modulu 6 ta ’ dan l- EPAR.
Other information about Quadrisol:
Tagħrif ieħor dwar Quadrisol:
The European Commission granted a marketing authorisation valid throughout the European Union, for Quadrisol to Intervet International B. V. on 16 July 1997.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Quadrisol valida fl - Unjoni Ewropea kollha lil Intervet International B. V. fis- 16 ta ’ Lulju 1997.
Later approval was given for the oral use in dogs (February 1999) and a solution for injection for horses (November 1999); however, in August 2008 the Marketing Authorisation Holder withdrew these presentations for commercial reasons.
Aktar tard ingħatat approvazzjoni għall- użu orali fil- klieb (Frar 1999) u għal soluzzjoni għall- injezjoni fiż - żwiemel (Novembru 1999); madankollu, f' Awwissu 2008 id- detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq irtira dawn il- presentazzjonijiet għal raġunijiet kummerċjali.
Information on the prescription status of this product may be found on the label of the carton box that contains the product.
Tagħrif dwar l- istejtus ta ’ preskrizzjoni ta ’ dan il- prodott jista ’ jinstab fuq it- tikketta/ il- pakkett ta ’ barra.
This summary was last updated in December 2008.
Dan is- sommarju ġie aġġornat l- aħħar 12- 2008.
Route of administration
Mod ta ’ Amministrazzj oni
Oral gel
Ġell orali
Oral use
Għall- użu millħalq
Prefilled adjustable multidose syringes (PE)
Siringa multidose
1 syringe in a carton box
1 siringi ġo kaxxa talkartun
12 days
12 - il jum
Oral use
Żwiemel
3 syringes in a carton box
3 siringi ġo kaxxa talkartun
12 days
12- il jum
Quadrisol 100 mg/ ml oral gel for horses
Quadrisol 100 mg / ml ġell orali għaż- żwiemel
Each ml of Quadrisol oral gel contains:
Kull ml ta ’ Quadrisol ġell oralil fiħ:
Active substance:
Sustanzi Attiv/ i
Excipients:
Vedaprofen 100mg
Propylene glycol:
Sustanzi mhux attivi:
130 mg
Propilin glajkol 130 mg
For a full list of excipients, see section 6.1.
Għall- lista sħiħa ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Horse.
Żwiemel.
4.2 Indications for use, specifying the target species
4. 2 Indikazzjoni għal użu tal- Prodott, speċifikament fl- ispeċi
Reduction of inflammation and relief of pain associated with musculo-skeletal disorders and soft tissue lesions (traumatic injuries and surgical trauma).
Tnaqqis ta ’ infjammazjoni u uġigħ assoċjati ma diżordnijiet tas - sistema tal- muskoli u għadam u taqtiegħ fil- laħam (trawma minħabba xi korriment jew intervent kirurġiku).
In cases of anticipated surgical trauma, Quadrisol can be given prophylactically at least 3 hours prior to elective surgery.
4. 3 Kontra indikazzjonijiet
Do not use in foals under the age of 6 months.
Tużax f’ annimali li għandhom problemi fl - imsaren, fil- qalb, fwied jew kliewi. Tużax fi żwiemel ta ’ inqas minn sitt xhur.
Do not use in lactating mares.
Tużax fi dwieb li qed iredgħu.
Horses intended for racing and competition should be treated according to local requirements.
Żwiemel intenzjonati għat- tlielaq jew kompetizzjoni għandhom jiġu trattati skond ir- regolamenti tal - post.
Appropriate precautions must be taken for such horses to ensure compliance with competition regulations.
Għandhom jittieħdu l- prekawzjonijiet adattati sabiex ikun żgurat li ma jkunx hemm ksur tar - regolamenti tal- kompetizzjoni.
In case of doubt, it is advisable to test the urine.
Jekk ikun hemm dubju, hu rakkomandat li tagħmel test tal- urina.
If side effects occur, treatment should be discontinued.
Jekk ikun hemm xi effetti mhux mixtieqa, it- trattament għandu jitwaqqaf.
Horses with oral lesions should be assessed clinically and the attending veterinarian should take a decision as to whether treatment should be continued.
Żwiemel li għandhom brix f’ ħalqhom għandhom jiġu nvistati klinikament u l- veterinarju għandu jiddeċiedi jekk it- trattament għandux jitkompla.
If oral lesions persist, treatment should be discontinued.
Jekk il- brix fil- ħalq jippersisti, it- trattament għandu jitwaqqaf.
Horses should be monitored for oral lesions during treatment.
Iż- żwiemel għandhom jiġu mħarsa għal brix f’ ħalqhom matul it- trattament.
Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there may be potential risk of increased renal toxicity.
Evita li tuża f’ annimali diżidrati, ipovolimiċi u bi pressjoni baxxa, minħabba li jista ’ jkun hemm riskju ikbar ta ’ tossiċita tal- kliewi.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Prekawzjonijiet speċjali li għandhom jittiehdu mill- persuna li tamministra l- prodott mediċinali lill- annimali
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
F’ kas ta ’ inġestjoni aċċidentali, fittex għajnuna medika immedjatament u uri l- fuljett ta ’ informazzjoni jew it- tiketta tal- prodott lit- tabib.
Typical undesirable effects associated with NSAID use, such as lesions in the alimentary tract, soft faeces, urticaria and lethargy.
Effetti mhux mixtieqa tipiċi ta ’ NSAID s bħal brix fl- imsaren, ħmieġ artab, ħakk u għejja.
Side effects are reversible.
Dawn l - effetti huma riversibli.
The safety of the veterinary medicinal product has not been established during lactation
Il- ħarsien tas- saħħa tal- prodott mediċinali veterinarju ma ġiex stabbilit fi żmien il- ħalib
4.8 Interaction with other medicinal products and other forms of interaction
4. 8 Effetti fuq prodotti mediċinali ohra jew effetti ohra
Other NSAIDs, diuretics and substances with high protein binding may compete for binding and lead to toxic effects.
NSAID s oħra, dijuretiċi, u sustanzi oħra li għandhom kapaċita qawwija li jeħlu mal- proteina fil - plasma jistgħu jikkompetu u joħolqu effetti tossiċi.
Quadrisol must not be given with other NSAIDs or glucocorticosteroids.
Quadrisol m’ għandux jiġi amministrat flimkien ma NSAID s oħra jew glukokortikosterojdi.
For oral use.
Mill - ħalq:
Twice daily administration.
Amministra darbtejn kuljum. Doża inizjali ta ’ 2 mg/ kilogramm (2. 0 ml/ 100kilogramm).
An initial dose of 2 mg/ kg (2.0 ml/ 100 kg) is followed by a maintenance dose of 1 mg/ kg (1.0 ml/ 100 kg) given every 12 hours.
U doża ta ’ manteniment ta ’ 1 mg/ kilogramm (1. 0 ml/ 100kilogramma) kull 12 il - siegħa.
Treatment can be continued for a maximum of 14 consecutive days.
It- trattament jista ’ jdum sa massimu ta ’ erbatax il- ġurnata.
In case of prophylactic treatment, a maximum duration of treatment of 7 consecutive days is sufficient.
F’ każ ta ’ trattament profilattiku, trattament sa ’ massimu ta ’ sebat ’ ijiem huwa biżżejjed.
Bodyweight and dosage must be accurately determined to avoid overdosing.
Il- piż taż- żiemel għandu jkun determinat tajjeb sabiex ma jkunx hemm dożaġġ aktar milli hemm bżonn.
The gel is administered orally by inserting the nozzle of the syringe through the interdental space and depositing the required amount of gel on the back of the tongue.
Il - ġell għandu jiġi amministrat billi tpoġġi iż- żennuna tas- siringa fil - ħalq bejn is- snien u wara l - ilsien u tpoġġi l- ammont ta ’ ġell meħtieġ.
Before administration, the syringe should be adjusted to the calculated dosage by setting the ring on the plunger.
Qabel tamministra, is- siringa għandha tkun ikkalibrata għad - dożaġġ adattat billi wieħed jikkalibra l- iskorfina fuq fejn tagħfas.
It is advisable to administer the product before feeding.
Huwa rakkomandat li tuża l - prodott qabel l- ikel.
In cases of anticipated surgical trauma, Quadrisol can be given prophylactically at least 3 hours prior to elective surgery.
F’ każi antiċipati ta ’ trawma minħabba kirurġija, Quadrisol jista ’ jingħata profilattikament tal- anqas tlett siegħat qabel l- intervent kirurġiku.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
3 4. 10 Doża eċċessiva (sintomi, proċeduri ta emergenza, antidot), jekk ikun hemm bżonn
Lesions and bleedings in the alimentary tract, diarrhoea, urticaria, lethargy, inappetence.
Brix u telf ta ’ demm mill- imsaren, dijareja, ħakk, għejja u nuqqas ta ’ aptit ġew osservati.
If symptoms occur, treatment should be discontinued.
Jekk jiġru dawn is- sintomi, waqqaf it- trattament.
Symptoms are reversible.
Is- sintomi huma riversibbli.
Overdosing may lead to death of treated animals.
Doża eċċessiva tista ’ twassal għal mewt f’ annimali trattati.
3 4.11 Withdrawal period(s)
4. 11 Perjodu ta 'Tiżmim
12 days Not permitted for use in lactating animals producing milk for human consumption.
12 - il jum Mhux permess li jintuża f' annimali li qed jaħilbu, u li l- ħalib tagħhom qed jintuża għall- konsum tan - nies.
PHARMACOLOGICAL PROPERTIES
KWALITAJIET FARMAKOLOGIĊI
ATCvet code:
Sustanza anti- inflammatorja u mhux sterojde Kodiċi ATĊ veterinarja:
non-steroidal anti-inflammatory drug
5. 1 Kwalitajiet farmakodinamiċi:
Vedaprofen is a non-steroidal anti-inflammatory drug (NSAID) belonging to the propionic acid derivate group.
Vedaprofen huwa sustanza anti- inflammatorja u mhux sterojde (NSAID) derivativ tal- aċidu aril - propjoniku.
Vedaprofen inhibits the prostaglandin synthesis enzyme system (cyclo-oxygenase enzyme) and thus possesses anti-inflammatory, antipyretic and analgesic properties.
Vedaprofen iwaqqaf l- enżima li tagħmel il- prostaglandin (cyclo- oxygenase) u jippossedi kwalitajiet anti inflammatorji, anti piretiċi u analġesiċi.
Studies in the horse have demonstrated potent inhibition of prostaglandin E2 (PG E2) synthesis in exudate and thromboxane B2 synthesis in serum and exudate.
Studji fiż- żwiemel urew twaqqif qawwi fis - sintesi ta ’ prostaglandin E2 (PG E2) fit- tnixxija u tas- sintesi ta ’ tromboksejn B2 fis- sirum u t - tnixxija. Vedaprofen għandu atoma tal- karbonju asimmetrika i għaldaqstant huwa taħlita raċemika ta ’ (+) enantiomer u (-) enantiomer li t- tnejn jikkontribwixxu ghal kwalitajiet terapewtiċi tas- sustanza.
Vedaprofen contains an asymmetric carbon atom and, therefore, is a racemic mixture of a (+) enantiomer and a (-) enantiomer.
Il - (+) enantiomer huwa iktar qawwi sabiex iwaqqaf is- sintesi tal- prostaglandin.
The (+) enantiomer is more potent in inhibiting prostaglandin synthesis.
Madankollu enantiomer (+) u (-) huma qawwija ndaqs bhala antagonisti ta ’ PGF2α.
Bioavailability after oral administration is 80-90%, but is reduced significantly if medication is administered with food.
5. 2 Kwalitajiet Farmakokinetiċi
The terminal half-life following oral administration is 350-500 minutes and no accumulation occurs following repeated oral dosing.
Il- bioavilibilita wara amministrazzjoni orali hija ta '80 - 90%, iżda din tonqos sew jekk il- prodott jingħata mal- ikel.
Steady state is reached quickly following onset of treatment.
Il - half life T1/ 2 meta jiġi amministrat mill- ħalq hija ta '350 – 500 minuta.
Vedaprofen is highly bound to plasma proteins and extensively metabolised.
L- istat fiss tal- prodott jintlaħaq malajr, wara li wieħed jibda t- trattament.
The most abundant metabolite is a monohydroxylated derivative.
Vedaprofen l - aktar li ssibu huwa mwaħħal mal- proteini fil- plasma u jiġi metabolizzat estensivament.
All metabolites of vedaprofen were shown to be less active than the parent compound as determined by a thromboxane B2 formation inhibition assay.
Permezz ta 'studju fuq it- twaqqif tas- sintesi ta ’ tromboksejn B2 intwera li l- metaboliti kollha ta' vedaprofen kienu anqas attivi mis- sustanza primarja.
Approximately 70% of an orally administered dose is excreted in the urine.
Madwar 70% tad- doża fil- ħalq, kienet imneħħija mill- urina.
Water (minimum purified grade), Propylene glycol, Hydroxyethylcellulose, Potassium hydroxide (E525), Hydrochloric acid Chocolate flavour.
Ilma (grad minimu ta’ purifikazzjoni), prpilin glajkol, hydroxymethylcellulose, potassium hydroxide, toġħma taċ- ċikkulata.
6.3 Shelf life
M' hemm xejn magħruf.
2 months
3 snin Perjodu ta 'hażna wara li jinfetah il- kontenitur: xahrejn.
This veterinary medicinal product does not require any special storage conditions.
M’ hemmx prekawzjonijiet speċjali għal- ħażna.
6.5 Nature and composition of immediate packaging
6. 5 In- natura tal- materjal tal- kontenitur u ta dak li hemm go fih
The syringe is fitted with variable dose capability, adjustable in steps of 0.5 ml and graduated to 1 ml.
Siringa multidose ta ’ 30 ml magħmula minn żewġ tipi ta plastik: high density polyethylene( abjad) u low density polyethylene (abjad u naturali). Is- siringa hija mgħammra b’ apparat sabiex tirranġa d- doża fi gradi ta ’ 0. 5 ml u mmarkata kull ml.
The product is presented as a single syringe in a carton box or as a multipack of 3 syringes in a carton box.
Il- prodott huwa ppreżentat bħala siringa waħda ġo kaxxa tal - kartun jew 3 siringi ġo kaxxa tal- kartun.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6. 6 PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA 'PRODOTTI MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements
Mediċina veterinarja li ma ġietx użata jew prodotti oħra li ntużaw għal din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiż
Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Intervet International Wim de Korverstraat 35 5831 AN Boxmeer L - OLANDA Numru tat- telephone: +31 (0) 485 58 7085 Numru tal- fax: +31 (0) 485 58 5392
MARKETING AUTHORISATION NUMBERS
Numri ta 'Awtorizzazzjoni tal- Kummerċ
4 December 1997 / 13 November 2007
4 ta ’ Diċembru 1997
DATE OF REVISION OF THE TEXT
L- ewwel tiġdid:
27.08.2008
15 ta ’ Jannar 2003
Not applicable.
Mhux applikabli.
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIOLOĠIKA (/ BIOLOĠIĊI) ATTIVA( I) U > SID/ S- SIDIEN TA ’’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT >
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ 'L - AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL - PROVISTA JEW L- UŻU
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’’ L - AWTORIZZAZZJONI TAL- KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV
STATEMENT OF THE MRLs
DIKJARAZZJONI TA ’’ L- MRLs
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SID (/ S- SIDIEN TA ’’) L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Wim de Körverstraat 35 NL- 5831 AN Boxmeer Olanda
Rue de Lyons F – 27460 Igoville France
Rue de Lyons F- 27460 Igoville Franza
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
L- isem u l- indirizz tal- manifattur responsabbli mill- ħruġ tal- lott konċernat irid jidher fil - fuljett tal - informazzjoni dwar il- prodott.
To be supplied only on veterinary prescription.
Jiġu mogħtija biss bi preskrizzjoni veterinarja.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’’ L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV
Vedaprofen is included in Annex I of Council Regulation (EEC) No 2377/ 90 in accordance with the following table:
Vedaprofen huwa nklus f’ Aness I tar- Regolamenti tal- kunsill (EEC) No 2377/ 90 skond it - tabella mhurija hawn:
Pharmacologically active substance
Sustanza attiva farmakoloġikament
Marker residue
Residwu indikatur
Animal species
Speċi ta ’ annimali
Target tissues Other provisions
Tessuti milquta Proviżżjonijiet oħra
Equidae
Ekwini
Excipients are included in Annex II of Council Regulation (EEC) No.
Kliewi Fwied Muskoli Xaħam
2377/ 90 in accordance with the following table:
Sustanzi mhux attiva huma nklus f’ Aness I tar- Regolamenti tal- kunsill (EEC) No 2377/ 90 skond it - tabella mhurija hawn:
Pharmacologically active substance Animal Species
Sustanza attiva farmakoloġikament
Other provisions
Speċi ta ’ annimali
All food producing species
Annimali ghal l- iekel
7 Hydrochloric acid Propylene glycol2
7 Hydrochloric acid Propylene glycol2
L 045 of 15.02.97
L 045 of 15. 02. 97
100 mg/ ml oral gel for horses
{kaxxa tal- kartun}
Vedaprofen:
Vedaprofen 100 mg/ ml
Oral gel.
Ġell orali
Adjustable dose syringe, containing 30 ml gel (EU/ 2/ 97/ 005/ 001) 3 adjustable dose syringes, each containing 30 ml gel (EU/ 2/ 97/ 005/ 005)
Siringa ikkalibrata li fiha 30 ml ġell (EU/ 2/ 97/ 05/ 001) 3 siringi ikkalibrati li fihom 30ml ġell (EU/ 2/ 97/ 005/ 005)
Horse.
ŻWIEMEL
Reduction of inflammation and relief of pain.
Tnaqqis ta ’ nfjammazjoni u serħan mill- uġigħ.
For oral use.
Għall- amministrazzjoni mill- ħalq
12 days Not permitted for use in lactating animals producing milk for human consumption.
12 il- ġurnata Mhux permess li jintuża f' annimali li qed jaħilbu u li l- ħalib tagħhom qed jintuża għall- konsum tan - nies.
If side effect occurs, treatment should be discontinued.
Tużax f’ annimali li qed ireddgħu Ghal lista sħiħa ta ’ kontra- indikazzjonijiet, aqra l- fuljett ta 'tagħrif qabel tuża.
Do not use in lactating animals.
DATA TA 'SKADENZA
For full contra-indications, see package insert.
< Jiskadi {xahar / sena} >
No special precautions for storage.
M’ hemmx prekawzjonijiet speċjali għal ħażna.
2 months
Jekk tiftaħ uża fi żmien xahrejn
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
TAGĦRIF DWAR IR- RIMI TA 'MEDIĊINA MHUX UŻATA JEW MATERJAL ĦAŻIN IEĦOR, JEKK IKUN IL- KAZ
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Mediċina veterinarja li ma ġietx użata jew prodotti ohra li ntużaw għal din il- mediċina għandhom jintremew skond kif titlob il- ligi tal- pajjiz.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM "GĦAT- TRATTAMENT TAL- ANNIMALI BISS ” u KUNDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVVISTA U L- UŻU, jekk applikabbli
To be supplied only on veterinary prescription.
Jingħata biss fuq preskrizzjoni veterinarja.
Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
INTERVET International B. V Wim de Korverstraat 35 5831 An Boxmeer Olanda
MARKETING AUTHORISATION NUMBERS
NUMRU TAL- AWTORIZAZZJONI GĦALL- KUMMERĊ FIR- REĠISTRU TAL - KOMUNITA
EU/ 2/ 97/ 005/ 001 (1 x 30 ml) EU/ 2/ 97/ 005/ 005 (3 x 30 ml)
EU/ 2/ 97/ 005/ 001 (1 x 30ml) EU/ 2/ 97/ 005/ 005 (3 X 30ml)
< Batch > < Lot > < BN > {number}
< Lott > {numru}
12 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
12 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L - IPPAKKJAR IMMEDJAT {tiketta fuq s- siringa}
Quadrisol 100 mg/ ml oral gel for horses
Quadrisol 100 mg / ml ġell orali għaż- żwienel
QUANTITY OF THE ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA ATTIVA U SUSTANZI OĦRA
Propylene glycol:
Vedaprofen Propajlin glajkol
100 mg/ ml 130 mg/ ml
100mg / ml 130 / ml
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
KONTENUT Bħala PIŻ, VOLUM JEW NUMRU TA ’ DOŻI
ROUTE OF ADMINISTRATION
METODU U MOD TA 'AMMINISTRAZZJONI
12 days
12 - il jim
BATCH NUMBER
LOTT NUMRU
< Batch > < Lot > < BN > {number}
Lott
Month/ year.
< Jiskadi {xahar / sena} >
14 PACKAGE LEAFLET
14 FULJETT TA 'TAGĦRIF
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
L- ISEM U INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ U L - ISEM U INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONASABBLI LI JHALLI L- KONSENJA TMUR FUQ IS SUQ, JEKK DIFFERENTI
Marketing authorisation holder:
Sid tal- awtorizzazzjoni tal- kummerċ
Manufacturers for the batch release:
Manifattur responasabbli li jħalli l- konsenja fuq is- suq
Rue de lyons F- 27460 Igoville France
Rue de Lyons F- 27460 Igoville Franza
Quadrisol 100 mg/ ml oral gel for horses.
Quadrisol 100 mg / ml ġell orali għaż- żwiemel
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S)
DIKJARAZZJONI TAS- SUSTANZA ATTIVA U SUSTANZI OHRA
100 mg/ ml 130 mg/ ml
100 mg/ ml 130 mg/ milllitru
Reduction of inflammation and relief of pain associated with musculo-skeletal disorders and soft tissue lesions (traumatic injuries and surgical trauma).
Tnaqqis ta ’ infjammazjoni u uġiegħ assoċjati ma diżordnijiet tas - sistema tal- muskoli u għadam u taqtiegħ fil- laħam (trawma minħabba xi korriment jew intervent kirurġiku).
In cases of anticipated surgical trauma, Quadrisol can be given prophylactically at least 3 hours prior to elective surgery
F’ każi antiċipati ta ’ trawma minħabba kirurġija, Quadrisol jista ’ jingħata profilattikament tal- anqas tlett siegħat qabel l - intervent kirurġiku.
Do not use in animals suffering from alimentary tract disorders, impaired heart, liver and kidney function.
Tużax f’ annimali li għandhom problemi fl - imsaren, fil- qalb, fwied jew kliewi..
Do not use in foals under the age of 6 months.
Tużax fi żwiemel ta ’ inqas minn sitt xhur.
Quadrisol must not be given with other NSAIDs or glucocorticosteroids.
Tużax fi dwieb li qed irredgħu Quadrisol ma għandux jingħata ma NSAIDS jew Glukokortikosterojdi.
Typical non-steroidal anti-inflammatory drugs (NSAIDs) side effects such as lesions and bleedings in the alimentary tract, diarrhoea, urticaria, lethargy, inappetence.
Effetti mhux mixtieqa tipiċi ta ’ NSAID s bħal brix u telf ta ’ demm fl- imsaren, dijareja, ħakk, għejja jew nuqqas fl- aptit.
If symptoms occur, treatment should be discontinued.
Jekk ikun hemm xi effetti mhux mixtieqa, it- trattament għandu jitwaqqaf.
Symptoms are reversible.
Dawn is- sintomi huma riversibbli.
If you notice any other side effects, please inform your veterinary surgeon.
Jekk tinnota xi effetti oħra mhux mixtieqa, jekk jogħġbok informa lit- tabib veterinarju
Horse.
Żwiemel
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
DOŻA GĦAL KULL SPEĊI
Quadrisol is intended for twice daily administration.
Quadrisol huwa ntenzjonat sabiex jingħata darbtejn kuljum.
The advised dosage is an initial dose of 2 mg/ kg (2.0 ml/ 100 kg) followed by a maintenance dose of 1 mg/ kg (1.0 ml/ 100 kg) given every 12 hours.
Id- doża rakkomandata hija doża inizjali ta ’ 2 mg/ kilogramm (2. 0 ml/ 100kilogramm), u doża ta ’ manteniment ta ’ 1 mg/ kilogramm (1. 0 ml/ 100kilogramma) kull 12 il - siegħa.
For oral use.
Għall użu mill- ħalq.
Bodyweight and dosage rate must be accurately determined to avoid overdosing.
Il- piż taż- żiemel u d- dożaġġ għandhom jkunu determinati tajjeb sabiex ma jkunx hemm dożaġġ aktar milli hemm bżonn.
In case of prophylactic treatment, a maximum duration of treatment of 7 consecutive days is sufficient.
F’ każ ta ’ trattament profilattiku, trattament sa massimu ta ’ sebat ’ ijiem huwa biżżejjed.
The gel is administered orally by inserting the nozzle of the syringe through the interdental space and depositing the required amount of gel on the back of the tongue.
Il - ġell għandu jiġi amministrat billi tpoġġi ż- żennuna tas- siringa fil - ħalq bejn is- snien u wara l - ilsien u tpoġġi l- ammont ta ’ ġell meħtieġ.
12 days Not permitted for use in lactating animals producing milk for human consumption.
Mhux permess li jintuża f' annimali li qed jaħilbu u li l- ħalib tagħhom qed jintuża għall- konsum tan - nies.
No special precautions for storage.
M’ hemmx prekawzjonijiet speċjali għall- ħażna.
Do not use after the expiry date stated on the label.
Iż- żmien kemm idum tajjeb il- prodott wara li jinfetah il- kontenitur: xahrejn Tużax wara d- data tal- iskadenza fuq it- tikketta
The safety of the veterinary medicinal product has not been established during lactation.
Il- ħarsien tas- saħħa tal- prodott mediċinali veterinarju ma ġiex stabbilit fi żmien il- ħalib.
Quadrisol 100 mg/ ml can be used during pregnancy.
Quadrisol 100mg / ml jista ’ jintuża waqt it- tqala.
Horse with oral lesions should be assessed clinically and the attending veterinarian should take a decision as to whether treatment should be continued.
Żwiemel li għandhom brix f’ ħalqhom għandhom jiġu nvistati klinikament u l- veterinarju għandu jiddeċiedi jekk it- trattament għandux jitkompla.
If oral lesions persist, treatment should be discontinued.
Jekk il- brix fil- ħalq jippersisti, it- trattament għandu jitwaqqaf
16 Horse should be monitored for oral lesions during treatment.
16 Iż- żwiemel għandhom jiġu mħarsa għal brix f’ ħalqhom matul it- trattament.
Avoid the use in any dehydrated, hypovolaemic or hypotensive animals, as there may be potential risk of increased renal toxicity.
Evita li tuża f’ annimali diżidrati, ipovolimiċi u bi pressjoni baxxa, minħabba li jista ’ jkun hemm riskju ikbar ta ’ tossiċita tal - kliewi.
In case of doubt, it is advisable to test the urine.
Jekk ikun hemm dubju, hu rakkomandat li tagħmel test tal- urina
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
TAGĦRIF DWAR RIMI TA ’ MEDIĊINA MHUX UŻATA JEW MATERJAL ĦAŻIN IEĦOR, JEKK IKUN IL- KAŻ
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Mediċina veterinarja li ma ġietx użata jew prodotti ohra li ntużaw għal din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
DATA META ĠIE APPROVATA L- AĦĦAR IL- FULJETT INFORMATTIV
27.08.2008
TAGĦRIF IEĦOR
OTHER INFORMATION
Għall- trattament tal- annimali biss.
For animal treatment only.
Mhux kull daqs tal- pakett jistgħa jitpoġġa fuq is 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.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Jekk trid iktar informazzjoni dwar il- kundizzjoni medika jew it- trattament ta 'l- annimal tiegħek, ikkuntattja lil veterinarju tiegħek.
What is Rabigen SAG2?
X' inhu Rabigen SAG2?
Rabigen SAG2 is a vaccine againts rabies.
Rabingen SAG2 huwa vaċċin kontra r- rabbja.
It is presented as baits.
Il- mediċina hija ppreżentata bħala lixki.
What is Rabigen SAG2 used for?
Għal xiex jintuża Rabigen SAG2?
Rabigen SAG2 is used for the active immunisation of red foxes (Vulpes vulpes) and raccoon dogs (Nyctereutes procyonoides) to prevent infection by rabies virus.
Rabingen SAG2 jintuża għall- immunizzazzjoni attiva tal- volpijiet ħomor (Vulpes vulpes) u tal- klieb rakkun (Nyctereutes procyonoides) għall- prevenzjoni mill- infezzjoni tal- vajrus tar - rabbja.
The baits are distributed by land or by air.
Il- lixki jitferrxu mill- art jew mill- arja.
The number of baits distributed depends on the number of foxes or raccoon dogs and varies between 13 and 20 per square kilometre.
L- għadd ta 'lixki li jitferrxu jiddependi mill - għadd ta' volpijiet jew klieb rakkun u jvarja bejn 13 u 20 lixka għal kull kilometru kwadru.
Rabigen SAG2 can only be used by authorised personnel within the framework of vaccination campaigns against rabies.
Rabigen SAG2 jista 'jintuża esklussivament minn persunal awtorizzat bħala parti mill - kampanji ta' tilqim kontra r- rabbja.
How does Rabigen SAG2 work?
Kif jaħdem Rabigen SAG2?
Rabigen SAG2 is a vaccine.
Rabigen SAG2 huwa vaċċin.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
Il- vaċċini jaħdmu billi 'jgħallmu' lis- sistema immunitarja (id - difiżi naturali tal- ġisem) kif tiddefendi lilha nnifisha kontra l- mard.
Rabigen contains live rabies viruses.
Rabigen fih vajrusis tal - rabbja ħajjin.
The viruses have been selected because of their ‘ low virulence’ (limited ability to cause the disease).
Il- vajrusis intgħażlu minħabba l - 'virulenza baxxa' tagħhom (kapaċità limitata li jikkawżaw il- marda).
The viruses are contained in a sachet within a bait matrix.
Il- vajrusis jinsabu f' borża żgħira ġewwa matriċi appetitiva.
As the foxes or raccoon dogs eat the bait, they get exposed to the viruses and make antibodies against them.
Hekk kif il - volpijiet u l- klieb rakkun jieklu l- lixka, dawn jiġu esposti għall- vajrusis u jipproduċu l - antikorpi kontrihom.
If the foxes or racoon dogs are then exposed to the rabies virus later in life, they do not become infected.
F' każ li l- volpijiet u l- klieb rakkun jiġu esposti għall- vajrus tar- rabbja aktar tard f' ħajjithom, dawn ma jiġux infettati.
How has Rabigen SAG2 been studied?
Kif ġie studjat Rabigen SAG2?
Foxes The distribution of almost four million baits of the product during the field trials over four years have been followed by an intensive surveillance of the vaccination areas.
Volpijiet Wara d- distribuzzjoni ta 'madwar erba' miljun lixka tal- prodott matul il- provi fuq il- post fuq erba 'snin, twettqet sorveljanza intensiva taż- żoni tat- tilqim.
Raccoon dogs As raccoon dogs are considered a minor species, no field trials were carried out.
Klieb rakkun Billi l- klieb rakkun huma meqjusa bħala speċi minuri, ma twettqet l- ebda prova fuq il- post.
Efficacy was based on the efficacy results from laboratory studies and the extensive use of the vaccine in the field for foxes.
L - effikaċja kienet ibbażata fuq ir- riżultati relatati ma 'l- effikaċja mill- istudji ta' laboratorju u l - użu estensiv tal- vaċċin fil- qasam tal- volpijiet.
What benefit has Rabigen SAG2 shown during the studies?
Liema benefiċċju wera Rabigen SAG2 waqt l- istudji li twettqu?
When distributed in the wild, the SAG2 rabies vaccine bait was readily taken by free ranging foxes and raccoon dogs.
Il- lixka tal- vaċċin SAG2 kontra r- rabbja ttieħdet fil- pront mill- volpijiet u mill- klieb rakkun li jinsabu fil- beraħ meta tferrxet fl- ambjent naturali ta 'dawn l- annimali.
Following bait uptake, adult and fox cubs and raccoon dogs showed significant antibody response.
Wara li ħadu l- lixka, l - adulti u l- frieħ tal- volpi u l- klieb rakkun urew rispons ta 'antikorpi sinifikanti.
As a result, rabies decreased significantly in the vaccinated areas until its complete elimination.
B' riżultat ta 'dan, ir- rabbja naqset b' mod sinifikanti fiż- żoni mlaqqma sa ma ġiet eliminata totalment.
Moreover, the use of this vaccine has been efficiently preventing the vaccinated area from re-infection from still contaminated neighbouring areas.
Barra minn hekk, l- użu ta 'dan il- vaċċin ipprevjena b' mod effikaċi li ż- żoni mlaqqma jiġu infettati mill - ġdid minn żoni kontaminati mill- madwar.
No case of vaccine induced rabies was reported, confirming the safety of the vaccine in the field.
L- ebda każ ta 'rabbja indotta minn vaċċin ma ġie rrapportat u dan jikkonferma s- sigurtà tal- vaċċin fil- qasam.
The vaccine confers 6-month protection against rabies.
Il- vaċċin jagħti protezzjoni kontra r- rabbja għal sitt xhur.
What is the risk associated with Rabigen SAG2?
X' inhu r- riskju assoċjat ma 'Rabigen SAG2?
No undesirable effects have been shown for Rabigen SAG2.
L- ebda effett mhux mixtieq ma ntwera għal Rabigen SAG2.
It is recommended to wear rubber gloves when handling the bait.
Meta l- lixka tiġi mmaniġġata, huwa rakkomandat li jintlibsu ngwanti tal- gomma.
People handling and distributing this vaccine should be vaccinated against rabies.
Il- persuni li jimmaniġġaw u li jqassmu dan il- vaċċin għandhom jitlaqqmu kontra r- rabbja.
People whose immune system is weakened must not be allowed to handle this vaccine.
Il- persuni li s - sistema immunitarja tagħhom hija mdgħajfa ma għandhomx ikunu awtorizzati jimmaniġġaw dan il- vaċċin.
In the event of human exposure to the active substance of the vaccine, seek medical advice immediately and show the package leaflet or the label to the doctor.
F' każ ta 'esponiment mill- bniedem għas- sustanza attiva tal- vaċċin, fittex immedjatament għajnuna medika u uri lit- tabib il- fuljett ta' tagħrif jew it- tikketta.
Why has Rabigen SAG2 been approved?
Għaliex ġie approvat Rabigen SAG2?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Rabigen SAG2 exceed the risks for its use in red foxes and raccoon dogs to prevent infection by rabies virus and recommended that Rabigen SAG2 be given a marketing authorisation.
Il- Kumitat għal Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta 'Rabigen SAG2 huma akbar mir- riskji għall- użu tiegħu f' volpijiet ħomor u fi klieb rakkun għall- prevenzjoni ta' infezzjoni mill- vajrus tar- rabbja u rrakkomanda li Rabigen SAG2 jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Rabigen SAG2:
Tagħrif ieħor dwar Rabigen SAG2:
The European Commission granted a marketing authorisation valid throughout the European Union, for Rabigen SAG2 to Virbac S. A. on 6 April 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Rabigen SAG2 lil Virbac S. A. fis- 6 ta 'April 2000.
The marketing authorisation was subsequently renewed in 2005 and varied in April 2008 to include raccoon dogs as a new target species.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet sussegwentement imġedda fl- 2005 u modifikata f' April 2008 biex tinkludi l- klieb rakkun bħala speċi ġdida fil- mira.
Live attenuated rabies virus, SAG2 strain, minimum of 8 log10 CCID501
Virus inattivat tar - rabbja, tal- grupp
Oral suspension
Suspensjoni tittieħed mill -
Red foxes (vulpes vulpes), raccoon dogs (Nyctereutes procyonoides)
Volpijiet ħomor Użu orali (Vulpes vulpes)
PVC/ aluminium sachets embedded in a bait matrix
qartas ta ’ l - aluminju /
200 units (4x50)
200 unit (4x50)
Box containing 200 vaccinal baits
Kaxxa li fija 200
N/ A
SAG2 minimu ta ’ 8 ħalq log 10 CCID 50 / doża
Live-attenuated rabies virus, SAG2 strain minimum of 8 log10 CCID501
Virus inattivat tar - Suspensjoni rabbja, tal- grupp tittieħed mill - SAG2 minimu ta ’ 8 ħalq log 10 CCID 50 / doża
Red foxes (vulpes vulpes), raccoon dogs (Nyctereutes procyonoides)
Volpijiet ħomor Użu orali (Vulpes vulpes) u klieb raccoon (Nyctereutes procyonoides)
PVC/ aluminium sachets embedded in a bait matrix
qartas ta ’ l - aluminju / PVC miksi b’ sustanza appetittiva
400 units (2x200)
400 unit (2x200)
Box containing 400 vaccinal baits
Kaxxa li fiha 400 (2 x 200) lixka tal - vaċċin
Cell Culture Infective Dose 50%
Mhux applikabbli
Rabigen SAG2 oral suspension, for red foxes and raccoon dogs.
Rabigen SAG2 suspensjoni tittieħed mill- ħalq, għall volpijiet ħomor u klieb raccoon.
Live attenuated rabies virus, SAG2 strain
Virus inattivat tar- rabbja, tal- grupp SAG2
minimum 8 log10 CCID50*/ dose
minimu ta ’ 8 log 10 CCID 50 * / doża
Cell Culture Infective Dose 50%
Doża Infettiva tal- Kulturi taċ- Ċelloli 50%
Excipients:
Sustanzi oħra:
For a full list of excipients, see section 6.1.
Għal- lista sħiħa ta ’ sustanzi ara s- sezzjoni 6. 1.
Oral suspension
Suspensjoni tittieħed mill- ħalq.
Red foxes (Vulpes vulpes) and raccoon dogs (Nyctereutes procyonoides).
Volpijiet ħomor (Vulpes vulpes) u klieb raccoon (Nyctereutes procyonoides).
For the active immunisation of red foxes and raccoon dogs to prevent infection by rabies virus.
Għall- imunizzazzjoni ta ’ volpijiet ħomor u klieb raccoon sabiex tiġi impeduta l- infezzjoni bil- virus tar- rabbja.
The duration of protection is of at least 6 months.
Il- protezzjoni ddum minn ta ’ lanqas 6 xhur.
4.4 Special warnings for each target species
4. 4 Twissijiet speċjali < għal kull speċi li għaliha hu indikat il- prodott
Baits shall not be distributed in inhabited areas, roads and watery areas.
Il- lixka m’ għandiex tiġi mxerda f’ żoni abitati, fit- toroq jew fejn hemm l- ilma.
People handling and distributing this vaccine should be vaccinated against rabies.
Huwa rakkomandat li jintlibsu l- ingwanti tal- lastktu.
Immunocompromised/ immunosuppressed individuals must not be allowed to handle this vaccine.
Ħaddiema li jżommu u jfornu dan il- vaċċin għandhom jiġu vvaċinati kontra r- rabbja.
In the event of human exposure to the active ingredient of the vaccine, seek medical advice immediately and show the package leaflet or the label to the physician.
Individwi immunokompromessi u immunodipressi m’ għandhomx jitħallew jiġġestixxu dan il- vaċċin.
2/ 22 4.6 Adverse reactions (frequency and seriousness)
2/ 23 Fil- każ ta ’ l- espożizzjoni fuq il- bniedem għas- sustanza attiva tal- vaċċin, fittex għal għajnuna medika minnufih u uri l- fuljett tal- pakett jew it- tikketta lit- tabib.
No undesirable effects have been shown for Rabigen SAG2.
L- ebda effetti mhux mixtieqa ma ntwerew minn Rabigen SAG2.
As this vaccine presentation contains traces of gentamicin and contains tetracycline as biomarker, occasional hypersensitivity reactions may be observed in domestic animals that have accidentally ingested the bait.
Peress li l- preżentazzjoni ta ’ dan il- vaċċin fiha traċċi ta ’ ġentamiċina u fiha tetraċiklina bħala bijoindikatur, jista ’ jkun li xi kultant jistgħu jiġu osservati xi reazzjonijiet ta ’ pressjoni għolja ħafna f’ annimali domestiċi li setgħu belgħu il- lixka b’ mod inċidentali.
The safety of the vaccine in pregnant and lactating animals has not been investigated.
Is- sigurtà tal- vaċċin ma ġietx investigata fil- każ ta ’ bhejjem tqal u ta ’ dawk li huma fi żmien il- ħalib.
However rabies virus and attenuated rabies vaccine viruses do not usually accumulate in reproductive organs and are not known to directly affect reproductive functions.
Imma l- virus tar- rabbja u virusijiet tal- vaċċin attenwat kontra r- rabbja normalment ma jakkumulawx fl- organi riproduttivi u mhumiex magħrufa li jaffettwaw direttament il- funzjonijiet riproduttivi.
The baits are distributed by land or by air within the framework of vaccination campaigns against rabies.
Il- lixka hi mqassma fuq l- art jew mill- ajru skond il- qafas tax- xogħol ta ’ kampanji ta ’ vaċinazzjoni kontra r- rabbja.
They are intended to be eaten by foxes / raccoon dogs.
Huma maħsuba sabiex jittieklu mill- volpijiet/ klieb raccoon.