qanastek/EMEA-V3 huggingface dataset:
Vaccinated animals can spread the Bordetella bronchiseptica vaccine strain for six weeks; in individual cases for at least one year.
Annimali vaċċinati jistgħu ixerrdu l- istrejn tal- vaċċin tal- Bordetella bronchiseptica sa sitt ġimgħat, f’ każijiet individwali anke sa sena.
Intermittent spreading is possible as well.
Huwa possibbli wkoll li jkun hemm tixrid li jieqaf u wara ftit jerġa jibda.
17 Although the risk of immunocompromised humans becoming infected with Bordetella bronchiseptica is extremely low, it is advised that cats that are in close contact with immunocompromised humans are not vaccinated with this vaccine.
Għalkemm ir- riskju li nies b’ immunita dgħajfa, jiġu nfettati bil- Bordetella bronchiseptica huwa estremament baxx, huwa tal- parir li qtates f’ kuntatt qrib ma nies bħal dawn ma jigux imlaqqma.
Such individuals should also be aware that cats can shed the organism for up to 1 year after vaccination.
Nies b’ immunita dgħajfa għandhom ikunu jafu li qtates imlaqqma jistgħu jibqgħu ixerrdu l- batterja sa sena wara t- tilqima.
Appropriate disinfection procedures should be used following use of this live bacterial vaccine.
Għandhom jintużaw proċeduri ta ’ disinfezzjoni flokhom wara l- użu ta ’ dan it- tilqim li fih batterja ħajja.
In case of accidental self-administration seek medical advice immediately and show the package leaflet or the label to the physician.
F' każ ta 'amministrazzjoni lilek innifsek, fittex parir mediku mal- ewwel u uri lit- tabib il- fuljett ta' informazzjoni li jkun hemm ġewwa jew it- tikketta ta ’ fuq il- pakkett.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA), http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /. >
For animal treatment only.
Għall trattament tal- annimali biss.
Presentation:
Preżentazzjoni:
Carton box with 5 vials of freeze-dried vaccine and 5 vials of sterile solvent.
Kaxxa tal- kartuna b’ 5 kunjetti ta ’ vaċċin imnixxef u ffriżat u 5 kunjetti b’ solvent sterili
18 ANNEX IV
18 ANNESS IV
GROUNDS FOR ONE ADDITIONAL RENEWAL
BAŻI SABIEX DIN L- AWTORIZZAZZJONI TIĠĠEDDED DARBA WAĦDA ADDIZZJONALI
The authorisation requires a further renewal for the following reasons:
L- awtorizzazzjoni għandha bżonn tiġġedded darb’ oħra għal dawn ir- raġunijiet:
- Limited exposure due to limited marketing.
- Espożizzjoni limitata minħabba kummerċjalizzazzjoni limitata.
What is Nobivac Piro?
X’ inhu Nobivac Piro?
Nobivac Piro is a vaccine that contains antigens (proteins) from the parasites Babesia canis and Babesia rossi.
Nobivac Piro huwa vaċċin li fih antiġeni (proteini) mill- parassiti Babesia canis u Babesia rossi.
Nobivac Piro is a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Nobivac Piro hu lyophilisate (freeze- dried pellet) u solvent li jitħalltu biex jiffurmaw sospensjoni għall- injezzjoni.
What is Nobivac Piro used for?
Għal x’ hiex jintuża Nobivac Piro?
Nobivac Piro is used to vaccinate dogs aged six months or older against B. canis, a protozoan (single-celled organism) transmitted by ticks that lives in red blood cells.
Nobivac Piro jintuża għat- tilqim ta ’ klieb li jkollhom sitt xhur jew iktar kontra B. canis, protozoan (organiżmu b’ ċellola waħda) trasmess mill- qurdien li jgħixu fiċ- ċelloli ħomor tad - demm.
The vaccine can reduce the severity of symptoms caused by acute (short-lived) babesiosis (the disease caused by infection with B. canis, with weakness, fever and jaundice) and anaemia (low red blood cell counts).
Il- vaċċin jista ’ jnaqqas is- severità tas- sintomi kkawżati minn babesiosis akuta (qasira) (il- marda kkawżata minn infezzjoni b’ B. canis, bi dgħjufija, deni u suffejra) u anemija (tnaqqis fiċ- ċelloli tad- demm ħomor).
For initial vaccination, Nobivac Piro is given as two 1-ml injections under the skin three to six weeks apart.
Għat- tilqima inizjali, Nobivac Piro jingħata f’ żewġ injezzjonjiet ta ’ 1 ml taħt il- ġilda fi spazju ta ’ bejn tlieta u sitt ġimgħat.
Re-vaccination is achieved with a single injection every six months.
It- tilqima mill- ġdid tinkiseb permezz ta ’ injezzjoni waħdanija kull sitt xhur.
Immunity starts three weeks after the vaccination course and lasts for at least six months.
L- immunità tibda tliet ġimgħat wara l- kors tat- tilqima u ddum ta ’ l- inqas sitt xhur.
Only healthy dogs should be vaccinated.
Għandhom jitlaqqmu biss klieb f’ saħħithom.
Dogs that are infected with B. canis but have no symptoms should be treated appropriately before vaccination.
Il- klieb infettati b ’ B. canis ma jkollhom l- ebda sintomu iżda għandhom jiġu ttrattati kif suppost qabel it- tilqima.
It is recommended that the vaccination is given at least one month before the tick season and exposure to ticks be reduced during the vaccination period.
Huwa rrakkomandat li t - tilqima tingħata ta ’ l- anqas xahar qabel l- istaġun tal- qurdien u l- espożizzjoni għall- qurdien għandha titnaqqas waqt il- perjodu tat- tilqim.
How does Nobivac Piro work?
Kif jaħdem Nobivac Piro?
Nobivac Piro is a vaccine.
Nobivac Piro hu tilqima.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against diseases.
It- tilqima taħdem billi ‘ tgħallem ’ lis- sistema imunitarja (id- difiża naturali tal- ġisem) kif tiddefendi lilha nnifisha kontra l- mard.
Nobivac Piro contains small amounts of antigens (soluble parasite antigens) from B. canis and the related species B. rossi that have been extracted from cultures of the parasites in red blood cells.
Nobivac Piro fih ammonti żgħar ta ’ antiġeni (antiġeni tal- parassit li jinħallu) minn B. canis u speċi B. rossi relatati li jkunu ġew estratti mill- parassiti kkultivati fiċ- ċelloli tad- demm ħomor.
The vaccine also contains an ‘ adjuvant ’ (a compound called saponin) to stimulate a better response.
It- tilqima fiha wkoll kompost magħruf bħala saponin li jistimulaha tipproduċi rispons aħjar.
When a dog is given the vaccine, the immune system recognises the antigens as ‘ foreign’ and makes antibodies against them.
Meta kelb jingħata t- tilqima, is - sistema immunitarja tagħraf l- antiġeni bħala ‘ barranin ’ u tipproduċi antikorpi kontrihom.
In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to B. canis.
Fil - futur, is- sistema immunitarja tkun kapaċi tipproduċi antikorpi iktar malajr meta jiġu esposti għal B. canis.
This helps to reduce the symptoms of babesiosis.
Dan jgħin fit- tnaqqis tas- sintomi ta ’ babesiosis.
Because the antigens on B. canis are very variable, vaccines against B. canis only work effectively if they also include antigens from B. rossi.
Billi l- antiġenti fuq B. canis huma varjabbli ħafna, it- tilqimiet kontra B. canis jaħdmu effettivament biss jekk jinkludu wkoll antiġeni minn B. rossi.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Nobivac Piro been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat Nobivac Piro?
The effectiveness of Nobivac Piro has been studied in three laboratory studies in which dogs were vaccinated and then challenged (exposed to wild type Babesia).
L- effikaċja ta ’ Nobivac Piro ġiet studjata fi tliet studji tal- laboratorju li fihom il- klieb tlaqqmu u mbagħad ġew esposti għal Babesia tat- tip selvaġġ.
Further one main field study was performed, including dogs of at least six months of age of various breeds who received two injections of Nobivac Piro three weeks apart.
Sar ukoll studju ieħor f’ ambjent naturali li fih klieb ta ’ mill- inqas sitt xhur ta ’ diversi razez ingħataw żewġ injezzjonijiet ta ’ Nobivac Piro fi spazju ta ’ tliet ġimgħat bejniethom.
The effects of vaccination were compared with those of vaccination using a placebo (a dummy treatment).
L- effetti tat- tilqima tqabblu ma ’ dawk tat- tilqima bl- użu ta ’ plaċebo (trattament finta).
The main measure of effectiveness was the proportion of the dogs that developed antibodies against B. canis and B. rossi two weeks after the second injection.
Il- kejl ewlieni ta ’ l- effikaċja kien il- proporzjon ta ’ klieb li żviluppaw antikorpi kontra B. canis u B. rossi ġimagħtejn wara t- tieni injezzjoni.
What benefit has Nobivac Piro shown during the studies?
X’ benefiċċji ta ’ Nobivac Piro ntwerew f’ dawn l- istudji?
Nobivac Piro was more effective than placebo at stimulating the production of antibodies: more dogs receiving the vaccine developed antibodies than those receiving placebo.
Nobivac Piro kien iktar effettiv mill- plaċebo fl- istumulazzjoni tal- produzzjoni ta ’ antikorpi: kien hemm iktar klieb li kienu ngħataw it- tilqima li żviluppaw l- antikorpi meta mqabbla ma ’ dawk li kienu ngħataw plaċebo.
What is the risk associated with Nobivac Piro?
X’ inhu r- riskju assoċjat ma ’ Nobivac Piro?
After vaccination, painful swelling or hardened nodules occur commonly at the site of vaccination.
Wara t- tilqima, hu komuni li jkun hemm nefħiet li jweġġgħu jew noduli iebsin fis- sit ta ’ l - injezzjoni.
In general, these disappear within four days, but in rare cases they can persist for up to 14 days after the second injection.
B’ mod ġenerali, dawn jgħibu fi żmien erbat ijiem, iżda f’ każijiet rari jistgħu jippersistu sa 14- il jum wara t- tieni injezzjoni.
Side effects such as lethargy (listlessness) and a reduction in appetite are also common, sometimes accompanied by fever and a stiff gait.
Xi drabi dawn ikunu akkompanjati minn deni u minn twebbis tal- ġisem.
These reactions should disappear within two to three days.
Dawn ir- reazzjonijiet għandhom jisparixxu fi żmien jumejn jew tlieta.
Vaccination with Novibac Piro does not prevent infection, so a milder form of disease caused by B. canis can occur.
It- tilqimiet b’ Novibac Piro ma jipprevenux infezzjoni, u allura, bihom tista ’ sseħħ forma inqas gravi tal- marda kkawżata minn B. canis.
If mild symptoms occur and last for more than two days, veterinary advice should be sought.
Jekk ikun hemm sintomi ħfief u li jdumu iktar minn jumejn, għandu jinkiseb parir veterinarju.
Nobivac Piro should not be used in bitches that are pregnant or lactating.
Nobivac Piro m’ għandux jintuża fi klieb nisa li jkunu tqal jew qed ireddgħu.
If accidental self-injection occurs, seek medical advice immediately and show the Package Leaflet or the label to the doctor.
Il- Fuljett ta ’ Tagħrif jew it- tikketta għandhom jintwerew lit- tabib.
Why has Nobivac Piro been approved?
Għaliex ġie aprovat Nobivac Piro?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobivac Piro exceed the risks for active immunisation of dogs of six months or older against B. canis to reduce the severity of clinical signs associated with acute babesiosis (B. canis) and anaemia as measured by packed cell volume, and recommended that Nobivac Piro be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċju ta ’ Nobivac Piro huma ikbar mir- riskju tiegħu meta użat fit- tilqim attiv ta ’ klieb ta ’ sitt xhur jew iktar kontra B. canis fit- tnaqqis tas- severità tas- sinjali kliniċi assoċjati ma ’ babesiosis akuta (B. canis) u l- anemija kif imkejla mill- volum taċ- ċelloli ppakkjati, u rrakkomanda li Nobivac Piro jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ bejn il- benefiċċju u r - riskju jinsab fil- modulu 6 ta ’ dan l- EPAR.
Other information about Nobivac Piro:
Tagħrif ieħor dwar Nobivac Piro:
The European Commission granted a marketing authorisation valid throughout the European Union for Nobivac Piro to Intervet International B. V. on 2 September 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Nobivac Piro lil Intervet International B. V. fit- 2 ta ’ Settembru 2004.
This summary was last updated on 30 August 2007.
Dan is- sommarju ġie aġġornat l- aħħar fit- 30 ta ’ Awwissu 2007.
Trade name Strength
Isem kummerċjali
Route of administratio n
Speċi li fuqhom għandu jintuża l - prodott
Packaging
Mod ta ’ Amministra zzjoni
Content
Ippakkjar Kontenut
606 (301- 911) total antigenic mass units
606 (301 - 911) unità ta ’ massa antiġenika totali
Lyophilisate + solvent for suspension for injection
Lajofiliżejt + solvent għal - suspensjoni għall - injezzjoni
Subcutaneous Cardboard box use
Kaxxa tal - kartun
1 vial of freeze- dried antigen and 1 vial of aqueous adjuvant
Fjala 1 ta ’ freeze- dried antigen u fjala 1 ta ’ aqueous adjuvant
3 ml vials of glass Type I (Ph. Eur.) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap
Fjali ta ’ 3 ml tal- ħġieġ Tip I (Ph. Eur.) magħluqa b’ tapp tal- lastku halogenobutyl u ssiġillat b’ tap ta ’ l- aluminju b’ kowd
5 vials of freeze- dried antigen and 5 vials of aqueous adjuvant
5 fjali ta ’ freeze- dried antigen u 5 fjali ta ’ aqueous adjuvant
10 vials of freeze- dried antigen and 10 vials of aqueous adjuvant
10 fjali ta ’ freeze- dried antigen u 10 fjali ta ’ aqueous adjuvant
Per 1 ml dose:
Kull doża ta ’ ml
606 (301-911) total antigenic mass units of soluble parasite antigen (SPA) from Babesia canis and Babesia rossi cultures
Total ta ’ 606 (301- 911) partijiet antiġeniċi ta ’ massa (SPA) minn kulturi ta ’ Babesia canis u Babesia rossi.
Adjuvant (in the solvent) 250 (225-275) µg saponin
250 (225 – 275 µg saponin
Lyophilisate and solvent for suspension for injection
Lajofiliżejt u solvent għal suspensjoni għal injezzjoni
For active immunisation of dogs of 6 months of age or older against Babesia canis to reduce the severity of clinical signs associated with acute Babesiosis (B. canis) and anaemia as measured by Packed Cell Volume (PCV).
Canis) u anemja kif imkejla mill- volum ta ’ ċelloli ppakkjati.
Onset of immunity:
L- immunita tibda minn:
Three weeks after the basic vaccination course.
Tlett ġimgħat wara l- kors bażiku ta ’ vaċċinazzjoni.
Duration of immunity:
L- immunita ddum sa:
6 months after the last (re-)vaccination.
6 xhur wara l- aħħar (ri -) vaċċinazzjoni
See section 4.7.
Ara sezzjoni 4. 7
Only healthy dogs should be vaccinated.
Klieb b’ saħħithom biss ghandhom jiġu mlaqqma.
In particular, chronic asymptomatic carriers should be identified and treated before vaccination, with substances that do not compromise immunological responsiveness.
Klieb li jġorru l- marda kronokament, iżda ma jurux sintomi, għandhom jiġu identifikati u trattati qabel it- tilqim, b’ sustanzi li ma jikkompromettux ir - rispons għat- tilqima.
It is recommended that vaccinations are given at least one month before the tick season.
Huwa rakkomandat li t- tilqim jingħata tal- inqas xahar qabel jibda l- istaġun tal- qurdien.
As active babesia infection might interfere with the development of protective immunity, it is recommended to reduce exposure to ticks during the period of vaccination.
Minħabba li infezzjoni attiva ta ’ Babisja tista ’ tinterferixxi fl- iżvilupp ta ’ immunita protettiva, huwa rakkomandat li għandha titnaqqas l- espożizzjoni għall- qurdien matul il- żmien tat- tilqim.
2/ 17 Currently there is only evidence of the efficacy of the vaccine against challenge with B. canis.
Canis.
There is a possibility that vaccinated dogs facing a challenge with other babesia's may develop disease and require treatment.
Hemm il - possibilita li kieb imlaqqma u ffaċċjati b’ ċalinġ b’ babisjas oħra, jistgħu jimirdu u jkollhom bżonn trattament.
Vaccination with Nobivac Piro does not prevent infection.
Tilqima bin- Nobivac Piro ma tiprevenix infezzjoni.
As a consequence a milder form of disease caused by B. canis can occur.
Konsegwentement tista ’ toħroġ forma dgħajfa tal - marda kkawżata minn B.
If mild babesia-like symptoms arise, which last for more than 2 days, veterinary advice should be sought.
Jekk joħorġu sintomi li jixbhu lil dawk tal- babisja u jdumu aktar minn jumejn, fittex parir ta ’ veterinarju.
Ensure that the lyophilisate is completely reconstituted before use.
Kun ċert li l- lajofiliżejt huwa mħallat tajjeb qabel tuża.
In general this disappears within 4 days.
Reazzjonijiet li jiġu rappurtati b’ mod komuni wara t- tilqim huwa nefħa mifruxa u / jew għoqda iebsa, akkumpanjati bl- uġiegħ, fil- post fejn ingħatat it- tilqima, li ġeneralment imorru fi żmien erbat’ ijiem.
In rare cases, the reactions after the second dose of vaccine may remain for 14 days.
Rarament dawn ir- reazzjonijiet jistgħu idumu sa 14 il- ġurnata wara t- tieni doża tat- tilqim.
In addition, systemic signs, such as lethargy and a reduction in appetite may also commonly occur, sometimes accompanied by pyrexia and a stiff gait.
Ma dawn jiġri b' komuni li l- annimal ikollu sinjali nterni, bħal telqa u nuqqas ta ’ aptit, kultant bid- deni u b’ ħarsa ċassa.
These reactions should disappear within 2-3 days.
Dawn ir- reazzjonijiet ġeneralment imorru fi żmien jumejn jew tlieta.
4.7 Use during pregnancy and lactation
4. 7 Użu fit- Tqala u fi żmien il- ħalib
Do not use in pregnant or lactating bitches.
Tużax waqt it- Tqala jew waqt li- l- kelbiet ikunu jreddgħu.
No information is available on the safety and efficacy of the concurrent use of this vaccine with any other.
M' hemmx informazzjoni dwar is- sigurtà u l- effiċjenza ta ’ din it- tilqima jekk tintuża flimkien ma kwalunkwe prodott ieħor.
It is therefore recommended that no other vaccines should be administered concurrently or simultaneously.
Għaldaqstant huwa rakkommandat li ma tintuża l- ebda tilqima oħra fl- istess żmien jew flimkien ma din it- tilqima.
Vaccination scheme:
Skema ta ’ tilqim:
Basic vaccination course:
Kors ta ’ tilqim bażiku:
First injection from 6 months of age, second injection 3 to 6 weeks later.
L- ewwel titqiba minn sitt xhur, it- tieni tiqiba 3 – 6 ġimgħat war.
Single dose, every 6 months after the last (re-)vaccination.
Ri- vaċċinazzjoni: doża waħda, kull sitt xhur wara l- aħħar (ri -) vaċċinazzjoni.
Aseptically add the solvent to the lyophilisate.
B’ mod asettiku, żid is- solvent mal - lajofiliżejt.
DO NOT SHAKE, but swirl gently.
Ħalli l- lajofiliżejt idub kompletament, TĦABBATX, dawru bil- mod.
Withdraw the entire contents of the reconstituted vaccine into a sterile syringe and administer the whole contents subcutaneously.
Iġbed it- taħlita kollha tal- vaċċin ġo siringa sterili, u amministra l- kontenut kollu taħt il- ġilda.
Not different from one dose.
Mhux differenti minn doża waħda.
To stimulate active immunity against babesiosis caused by Babesia canis.
Sabiex jistimula immunita attiva kontra l - babisjosi kkawżata minn Babesia canis.
QI07AO
Kodici ATĊ veterinarja QI07AO
Vaccine: culture medium Solvent: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, water for injection.
Vaċċin: materja għall- kultura Solvent:
Do not mix with any other vaccine or immunological product.
Fosfat dihidrat tas- sodjumdihidroġenat, fosfat dihidrat tad- disodjum, ilma ghal injezzjoni.
2 years Reconstituted product should be used immediately.
6. 2 Inkompatibilitajiet
Store and transport refrigerated (2°C - 8°C).
Lajofiliżejt: sentejn Solvent: sentejn Il- prodott imħallat għandu jintuża mal- ewwel.
Protect from light.
Tagħrif speċjali dwar kif għandu jinħażen
6.5 Nature and composition of immediate packaging
Aħżen u ttrasporta ġo friġġ (2°C – 8°C) Ipproteġi mid- dawl
For the lyophilisate and the solvent:
6. 5 In- natura u l- għamla ta ’ l- ewwel ippakkjar
3-ml vials of glass Type I closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Il- lajofiliżejt u s- solvent: fjali ta ’ 3ml, magħmula minn ħġieġ Tip I, magħluq b’ tapp tal- gomma ssiġillat b’ kappa tal- aluminjum b’ kodiċi fuqha.
Cardboard box containing 1 vial of lyophilisate and 1 vial of solvent.
Kaxxa tal- kartun li fiha fjala waħda ta ’ lajofiliżejt u fjala waħda ta ’ solvent.
Cardboard box containing 5 vials of lyophilisate and 5 vials of solvent.
Kaxxa tal- kartun li fiha 5 fjali ta ’ lajofiliżejt u 5 fjali ta ’ solvent.
Cardboard box containing 10 vials of lyophilisate and 10 vials of solvent.
Kaxxa tal- kartun li fiha 10 fjali ta ’ lajofiliżejt u 10 fjali ta ’ solvent.
Wim de Körverstraat 35 NL - 5831 AN Boxmeer
Wim de Körverstraat 35 NL – 5831 AN Boxmeer.
2 September 2004
2 ta ’ Settembru 2004
5/ 17 ANNEX II
5 ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
A. < MANIFATTUR( I) TAS- SUSTANZA( I) BIOLOĠIKA (/ BIOLOĠIĊI) ATTIVA( I) U > SID/ S- SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT >
CONDITIONS OF THE MARKETING AUTHORISATION INCLUDING RESTRICTIONS REGARDING SUPPLY AND USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L - AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL - PROVISTA JEW L- UŻU
PROHIBITION OF SALE, SUPPLY AND/ OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L - AWTORIZZAZZJONI TAL- KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV
6/ 17 A.
BIOLOĠIKA
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL - LOTT
Name and address of the manufacturers of the biological active substance(s)
Isem u indirizz tal- manufattur( i) tas- sustanza bioloġika attiva
Wim de Korverstraat 35, Boxmeer The Netherlands
Wim de Körverstraat 35, Boxmeer The Netherlands
Veterinary medicinal product subject to medical prescription.
Prott veterinarju li għandu jiġi mogħti biss bi preskrizzjoni veterinarja.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Is- sid ta ’ din l- Awtorizzazzjoni tal- Kummerċ, għandu jinforma lil Kummissjoni Ewropeja, dwar il - pjanijiet ta ’ kummerċ tal- prodott mediċinali awtorizzat b’ din id- deċiżjoni.
7/ 17 ANNEX III
7 ANNESS III
9/ 17 PARTICULARS TO APPEAR ON THE OUTER PACKAGE OR, WHERE THERE IS NO OUTER PACKAGE, ON THE IMMEDIATE PACKAGE
9 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Outer box
Pakkett ta ’ barra
STATEMENT OF ACTIVE AND OTHER SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA ATTIVA U SUSTANZI OĦRA
Per dose:
Sustanza Attiva:
Lyophilisate and solvent for suspension for injection.
Lajofiliżejt u solvent għal suspensjoni għal injezzjoni
1 x 1 dose 5 x 1 dose 10 x 1 dose
1 x 1 doża 5 x 1 doża 10 x doża
Vaccine against Babesia canis.
Tilqim kontra Babesia canis.
S. C. injection
Titqiba taħt il- ġilda.
See Package Insert
Aqra l- fuljett ta 'tagħrif.
{date}
Jis {xahar / sena}
Reconstituted vaccine should be used immediately.
Aħżen u ttrasporta ġo friġġ (2 – 8oC) Ipproteġi mid- dawl Vaċċin imħallat għandu jintuża mill- ewwel.
Disposal: see package insert
Aqra l- fuljett ta 'tagħrif fil- pakkett
Veterinary medicinal product subject to prescription.
Għal Trattament ta ’ l- Annimali Biss Prodott mediċinali veterinarju li jiġi mogħti biss b’ riċetta veterinarja.
EU/ 2/ 04/ 046/ 001-003
EU/ 02/ 04/ 046/ 001 EU/ 02/ 04/ 046/ 002 EU/ 02/ 04/ 046/ 003
Lot:
Numru tal- lott:
11/ 17 PARTICULARS TO APPEAR ON SMALL SINGLE DOSE CONTAINERS OTHER THAN AMPOULES
11 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
Label of the vaccine
Tikketta tal- vaċċin
606 (301-911)units Babesia antigens
Mhux applikabbli
ROUTE(S) OF ADMINISTRATION
KONTENUT BĦLA PIŻ, VOLUM JEW NUMRU TA ’ DOŻI
S. C.
Doża 1
BATCH NUMBER
MOD TA ’ AMMINISTRAZZJONI
Lot:
s. c.
{date}
Lot {numru}
THE WORDS "FOR ANIMAL TREATMENT ONLY"
DATA TA 'SKADENZA
For animal treatment only.
Exp {xahar/ sena}
12/ 17 PARTICULARS TO APPEAR ON SMALL SINGLE DOSE CONTAINERS OTHER THAN AMPOULES
IL- KLIEM "GĦAL TRATTAMENT TAL- ANNIMALI BISS ”
MINIMUM PARTICULARS TO APPEAR ON AMPOULES
12 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
Label of the adjuvant
Tikketta tal- adjuvant
Adjuvated solvent for Nobivac Piro.
Solvent adjuvat għal Nobivac Piro
{number}
Lot {numru}
{date}
Exp {xahar/ sena}
For animal treatment only
Għal Trattament tal- Annimali Biss.
14/ 17 PACKAGE LEAFLET
14 FULJETT TA ’ TAGĦRIF FIL- PAKKETT
Wim de Körverstraat 35 NL - 5831 AN Boxmeer
Wim de Körverstraat 35, Boxmeer The Netherlands
Per 1 ml dose of the reconstituted product:
Kull doża ta ’ ml ta ’ proott imħallat:
606 (301-911) total antigenic mass units of soluble parasite antigen (SPA) from Babesia canis and Babesia rossi cultures Adjuvant:
Total ta ’ 606 (301- 911) partijiet antiġeniċi ta ’ massa (SPA) minn kulturi ta ’ Babesia canis u Babesia rossi.
250 (225-275) µg saponin (from the solvent)
250 (225 – 275 µg saponin (mis- solvent)
Do not use in pregnant or lactating bitches.
Tużax waqt it- Tqala jew waqt li l- kelbiet ikunu jreddgħu.
1 ml reconstituted vaccine, via subcutaneous injection.
Agħti 1ml ta’ vaċċin imħallat, bħala titqiba taħt il- ġilda.
First injection from 6 months of age, second injection 3-6 weeks later.
L- ewwel titqiba minn sitt xhur, it- tieni tiqiba 3 – 6 ġimgħat war.
Single dose, every six months after the last (re-) vaccination.
Ri- vaċċinazzjoni: doża waħda, kull sitt xhur wara l- aħħar (ri -) vaċċinazzjoni.
DO NOT SHAKE, but swirl gently.
Ħalli l- lajofiliżejt idub kompletament, TĦABBATX, dawru bil- mod. Kun żgur li l - lajofiliżejt dab sew qabel tuża.
Make sure that the lyophilisate is completely dissolved before use Withdraw the entire contents of the reconstituted vaccine into a sterile syringe and administer the whole contents subcutaneously.
Iġbed it- taħlita kollha tal- vaċċin ġo siringa sterili, u amministra l - kontenut kollu taħt il- ġilda.
SPECIAL STORAGE CONDITIONS, IF ANY
PREKAWZJONIJIET SPEĊJALI GĦALL- ĦAŻNA
Keep out of reach and sight of children.
Aħżen fil- friġġ (2°C – 8°C) Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
As active Babesia infection might interfere with the development of protective immunity it is recommended to reduce exposure to ticks during the period of vaccination.
Minħabba li infezzjoni attiva ta ’ Babisja tista ’ tinterferixxi fl- iżvilupp ta ’ immunita protettiva, huwa rakkomandat li għandha titnaqqas l- espożizzjoni għall- qurdien matul il- żmien tat- tilqim.
Currently there is only evidence of the efficacy of the vaccine against challenge with B. canis.
Canis.
If mild babesia-like symptoms arise which last for more than 2 days veterinary advice should be sought.
Jekk joħorġu sintomi li jixbhu lil dawk tal- babisja u jdumu aktar minn jumejn, fittex parir ta ’ veterinarju.
In the absence of compatibility studies, do not mix with any other product except the solvent supplied for use with the vaccine.
Fin- nuqqas ta ’ studji ta ’ kumpattibilita, tħallatx ma xi prodott ieħor ħlief mas- solvent li hemm mal - vaċċin.
{date}
data
What is Novem?
X' inhu Novem?
Novem is a solution for injection, which comes in two strengths:
Novem huwa soluzzjoni għal injezzjoni li hija disponibbli f' żewġ dożaġġi:
5 mg/ ml and 20 mg/ ml.
5 mg/ ml u 20 mg/ ml.
What is Novem used for?
Għal xiex jintuża Novem?
Novem is used to relieve inflammation and pain in both acute and chronic musculo-skeletal disorders.
Novem jintuża biex itaffi l- infjammazzjoni u l- uġigħ fid- disturbi muskoloskeletriċi tat- tip akut kif ukoll kroniku.
Novem is used in cattle for acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs.
Novem jintuża fil- bhejjem tal- ifrat fit- trattament tal- infezzjonijiet respiratorji akuti flimkien ma 'terapija antibijotika xierqa biex jitnaqqsu s- sinjali kliniċi.
It is also used for diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle; and also as supportive therapy in the treatment of acute mastitis, in combination with antibiotics.
Jintuża wkoll f' każ ta 'dijarrea, f' kombinazzjoni ma' terapija reidratanti orali, biex jitnaqqsu s- sinjali kliniċi fl- għoġiela ta 'età' l fuq minn ġimgħa u f' bhejjem tal- ifrat ta 'età żgħira li mhumiex qegħdin fit- treddigħ, kif ukoll bħala terapija ta' sostenn fit- trattament tal- mastite akuta, f' kombinazzjoni ma 'antibijotiċi.
In pigs it is used for non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation, and also for supportive therapy in the treatment of septicaemia and toxaemia around farrowing (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.
Fil- ħnieżer jintuża għat- trattament tad- disturbi lokomotorji mhux infettivi biex jitnaqqsu s- sintomi ta 'zappip u infjammazzjoni u bħala terapija ta' sostenn flimkien ma 'terapija antibijotika xierqa fit - trattament tas- settiċemija (septicaemia) u tossjemija fit- tifrigħ (toxaemia around farrowing) (sindromu mastite- metrite- agalassija [mastitis- metritis- agalactia syndrome]).
How does Novem work?
Kif jaħdem Novem?
Novem contains meloxicam, which belongs to a class of medicines called non-steroidal anti- inflammatory drugs (NSAIDs).
Novem fih meloxicam, li jagħmel parti mill- klassi ta 'mediċini msejħin mediċini antinfjammatorji mhux sterojdali (NSAIDs).
As the prostaglandins are substances that trigger inflammation, pain, exudation and fever, meloxicam reduces those responses.
Minħabba li l- prostaglandini huma sustanzi li jikkawżaw l- infjammazzjoni, l- uġigħ, il- ħruġ ta 'għaraq u d- deni, meloxicam inaqqas dawn ir- reazzjonijiet.
How has Novem been studied?
Kif ġie studjat Novem?
Appropriate studies have been made to show the safety and effectiveness in the target animals.
Twettqu studji xierqa biex juru s- sigurtà u l- effikaċja fil- bhejjem fil- mira.
What benefit has Novem showed during the studies?
Liema benefiċċju wera Novem waqt l- istudji mwettqa?
Studies in cattle showed that the addition of Novem to antibiotics therapy significantly improved clinical parameters and reduced fever compared to antibiotics alone.
L- istudji fuq il- bhejjem tal- ifrat urew li ż- żieda ta 'Novem ma' terapija antibijotika tejbet konsiderevolment il- parametri kliniċi u naqset id- deni meta mqabbel mal- antibijotiċi waħedhom.
Similarly, treatment combining rehydration solution and Novem was shown to be superior to rehydration solution alone.
Bl - istess mod, it- trattament li jikkombina soluzzjoni reidranti u Novem wera li kien superjuri għas - soluzzjoni reidranti waħedha.
Studies in pigs showed that Novem reduces the symptoms of lameness and inflammation in non- infectious locomotor disorders.
Studji li saru fuq il- ħnieżer urew li Novem inaqqas is- sintomi ta 'zappip u ta' infjammazzjoni fid - disturbi lokomotorji mhux infettivi.
Similarly, treatment of mastitis-metritis-agalactia syndrome with adjunctive treatment of Novem and an appropriate antibiotic was shown to be superior to an antibiotic therapy alone.
Bl- istess mod, urew li kien superjuri għat- terapija antibijotika waħedha t- trattament tas- sindromu mastite- metrite- agalassija flimkien ma 'Novem u antibijotiku xieraq.
What is the risk associated with Novem?
X' inhu r- riskju assoċjat ma 'Novem?
In cattle and pigs both subcutaneous and intramuscular administration are well tolerated; only a slight temporary swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
L- għoti minn taħt il- ġilda u intramuskolari huwa tollerat sew fil- bhejjem tal- ifrat u fil- ħnieżer; ġiet osservata biss nefħa provviżorja fis- sit tal- injezzjoni wara l- għoti minn taħt il- ġilda f' inqas mill- 10% tal- bhejjem tal- ifrat ittrattati fi studji kliniċi.
People who are hypersensitive (allergic) to NSAIDs should avoid contact with Novem.
Il- persuni ipersensittivi (allerġiċi) għall- NSAIDs għandhom jevitaw il- kuntatt ma 'Novem.
In case of accidental self-injection, the advice of a doctor should be sought immediately.
F' każ ta 'awtoinjezzjoni aċċidentali, itlob immedjatament parir minn tabib.
After the last administration of Novem cattle should not be slaughtered for 15 days, and pigs should not be slaughtered for 5 days.
Wara li Novem jingħata għall- aħħar darba, il- bhejjem tal- ifrat ma jistgħux jinqatlu qabel ma jgħaddu 15- il jum u għall- ħnieżer wara 5 ijiem.
What is the time to allow before milk can be taken from the animal for human consumption?
Kemm irid jgħaddi żmien qabel ma jkun jista 'jittieħed ħalib mill- annimal għall- konsum mill - bniedem?
After the last administration of Novem to cattle, the milk should not be used for 5 days.
Wara li Novem jingħata għall- aħħar darba lill- bhejjem tal- ifrat, il- ħalib ma għandux jintuża għal 5 ijiem.
Why has Novem been approved?
Għaliex ġie approvat Novem?
The Committee for Medicinal Products for Veterinary Use (CVMP) decided that the benefits of Novem are greater than any risks of treatment and they recommended that Novem should be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) iddeċieda li l- benefiċċji ta 'Novem huma ogħla min kwalunkwe riskju tat- trattament u rrakkomanda li tinħareġ awtorizzazzjoni għat- tqegħid fis- suq għal din il- mediċina.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ bejn il- benefiċċji u r- riskji jista 'jiġi kkonsultat fil - modulu 6 ta' dan l- EPAR.
Other information about Novem:
Paġna 2/ 3 ©EMEA 2008 Aktar tagħrif dwar Novem:
The European Commission granted a marketing authorisation valid throughout the European Union, for Novem to Boehringer Ingelheim Vetmedica, Germany on 2 March 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Novem lil Boehringer Ingelheim Vetmedica, il- Ġermanja fit- 2 ta 'Marzu 2004.
Information on the prescription status of this product may be found on the label of the carton.
L- informazzjoni dwar l- istat tal- preskrizzjoni ta 'dan il- prodott jinstab fuq it- tikketta ta' dan il- pakkett.
Page 2/ 2
Paġna 3/ 3 ©EMEA 2008
Withdrawal period
Perjodu ta ’ tiżmim Laħam u l -
Cattle: subcutaneous injection Pigs: intramuscular injection
Injezzjoni
EU/ 2/ 04/ 042/ 003
Laħam u l - EU/ 2/ 04/ 042/ 003
15 days (cattle), 5 days (pigs) Milk:
jum (baqar), 5 ijiem (majjali) Ħalib:
EU/ 2/ 04/ 042/ 005
1/ 2 Laħam u l - EU/ 2/ 04/ 042/ 005
Novem 5 mg/ ml solution for injection for cattle and pigs
Novem 5 mg/ ml soluzzjoni għall- injezzjoni għall- baqar u l- majjali.
Each ml of Novem 5 mg/ ml solution for injection contains:
Kull ml ta ’ Novem 5 mg/ ml soluzzjoni għall- injezzjoni fih:
Subcutaneous and intramuscular administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
L- għoti taħt il- ġilda u fil- muskolu, hu tollerat tajjeb; kienet osservata biss nefħa ħafifa li tgħaddi malajr fis- sit ta ’ l- injezzjoni wara l- għoti taħt il- ġilda, f’ inqas minn 10% tal- baqar li kienu ttrattati fi studji kliniċi.
Single subcutaneous injection at a dosage of 0.5 mg meloxicam/ kg body weight (i. e.
Injezzjoni waħda taħt il- ġilda, b’ dożaġġ ta ’ 0. 5 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem (i. e.
10.0 ml/ 100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
10. 0 ml / 100 kg ta ’ piż tal- ġisem) flimkien ma ’ terapija antibijotika, jew ma ’ terapija orali ta ’ idratazzjoni mill - ġdid, skond kif ikun xieraq.
3 4.11 Withdrawal periods
3 4. 11 Perjodu ta ’ tiżmim
02.03.2004 Date of last renewal:
02. 03. 2004 Data ta ’ l- aħħar tiġdid:
Novem 20 mg/ ml solution for injection for cattle and pigs
Novem 20 mg/ ml soluzzjoni għall- injezzjoni għall- baqar u majjali
Each ml of Novem 20 mg/ ml solution for injection contains:
Kull ml ta ’ Novem 20 mg/ ml soluzzjoni għall- injezzjoni fih:
7 4.4 Special warnings
7 4. 4 Twissijiet speċjali
Subcutaneous and intramuscular administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
L- għoti taħt il- ġilda u fil- muskolu hu ittollerat tajjeb; kienet osservata biss nefħa ħafifa li tgħaddi malajr fis- sit ta ’ l- injezzjoni wara l- għoti taħt il- ġilda, f’ inqas minn 10% tal- baqar li kienu ttrattati fi studji kliniċi.
2.5 ml/ 100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
2. 5 ml / 100 kg ta ’ piż tal- ġisem) flimkien ma ’ terapija antibijotika, jew ma ’ terapija orali ta ’ idratazzjoni mill - ġdid, skond kif ikun xieraq.
8 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
8 4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti), jekk ikun hemm bżonn
Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves, lactating cows and pigs.
Meloxicam għandu wkoll proprjetajiet anti- endotossiċi għax intwera li jinibixxi l- produzzjoni ta ’ thromboxane B2 ikkaġunata mill- għoti ta ’ E. coli endotoxin fl- għoġġiela, baqar li jkunu qed ireddgħu u majjali.
9 In pigs, after intramuscular administration the mean plasma elimination half-life is approximately 2.5 hours.
9 Fil- majjali, wara li jingħata b’ injezzjoni ġol- muskoli, il- medja tal- half- life ta ’ l- eliminazzjoni tal - plażma hi ta ’ madwar 2. 5 sigħat.
Shelf-life of the veterinary medicinal product as packaged for sale (20, 50 or 100 ml vials):
Żmien li l- prodott mediċinali veterinarju jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ (kunjetti ta ’ 20, 50 jew 100 ml):
2 years Shelf-life after first opening the immediate packaging:
3 snin Żmien li l- prodott mediċinali veterinarju jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ (kunjetti ta ’ 250 ml): sentejn Żmien li l- prodott jibqa ’ tajjeb wara li jkun tneħħa mill- ewwel ippakkjar:
Colourless glass injection vial of 20, 50, 100 or 250 ml, closed with a rubber stopper and sealed with an aluminium cap.
Kunjett tal - ħġieġ għall- injezzjoni, ta ’ 20, 50, 100 jew 250 ml, mingħajr kulur, magħluq b’ tapp tal - lastku u ssiġillat b’ għatu ta ’ l- aluminju.
12 Novem 5 mg/ ml solution for injection for cattle and pigs
12 Novem 5 mg/ ml soluzzjoni għall- injezzjoni għall- baqar u l- majjali
14 Novem 20 mg/ ml solution for injection for cattle and pigs
14 Novem 20 mg/ ml soluzzjoni għall- injezzjoni għall- baqaru majjali
Other
Dispożizzjonijiet oħrajn
within the scope of Council Regulation 2377/ 90 at concentrations
Meglumine ma kienx ikkunsidrat fi ħdan l- iskop tar- Regolament tal- Kunsill 2377/ 90 f’ konċentrazzjonijiet sa 1. 5 mg/ kg ta ’ piż tal- ġisem (konċentrazzjonijiet sa 34. 75 mg/ ml)
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
18 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Novem 5 mg/ ml solution for injection for cattle and pigs Meloxicam
Meloxicam
Single subcutaneous injection.
Injezzjoni waħda taħt il- ġilda jew ġol- vini.
20 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
20 TAGĦRIF LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI
Pigs: intramuscular injection.
Baqar: injezzjoni taħt il- ġilda Majjali: injezzjoni ġol- muskoli.
22 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
22 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
Novem 20 mg/ ml solution for injection for cattle and pigs Meloxicam
Novem 20 mg/ ml soluzzjoni għall- injezzjoni għall- baqar u majjali Meloxicam
Single subcutaneous injection.
Injezzjoni waħda taħt il- ġilda
23 Pigs:
23 Majjali:
25 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
25 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
SC injection.
Jingħata b’ injezzjoni taħt il- ġilda
27 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
27 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
Novem 20 mg/ ml solution for injection for cattle and pigs Meloxicam
Meloxicam
SC
Jingħata b’ injezzjoni taħt il- ġilda.
29 PACKAGE LEAFLET FOR:
29 FULJETT TA ’ TAGĦRIF FIL- PAKKETT:
Marketing authorisation holder Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/ Rhein Germany
Sid l- Awtorizzazzjoni tal- Kummerċ Boehringer Ingelheim Vetmedica GmbH55216 Ingelheim/ Rhein Ġermanja
30 In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
30 F’ każijiet rari ħafna, reazzjonijiet anafilattojdi jistgħu jseħħu u dawn għandhom jiġu kkurati b’ mod sintomatiku.
31 Precautions to be taken by the person administering the product Accidental self-injection may give rise to pain.
31 Prekawzjonijiet li għandhom jittieħdu mill- persuna li tamministra l- prodott Injezzjoni aċċidentali tiegħek nnifsek tista ’ tikkaġuna wġigħ.
32 PACKAGE LEAFLET FOR:
32 FULJETT TA ’ TAGĦRIF FIL- PAKKETT:
Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Tużax f’ annimali li għandhom indeboliment fil- funzjoni tal- fwied, tal- qalb jew tal- kliewi, u mard emorraġiku, jew fejn ikun hemm evidenza ta ’ leżjonijiet gastrointestinali ulċeroġeniċi
33 Do not use in case of hypersensitivity to the active substance or to any of the excipients.
33 Tużax f’ każ ta ’ sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
Subcutaneous and intramuscular administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
L- għoti taħt l- ġilda u fil- muskolu, hu ittollerat tajjeb; kienet osservata biss nefħa ħafifa li tgħaddi malajr fis- sit ta ’ l- injezzjoni wara l- għoti taħt il- ġilda, f’ inqas minn 10% tal- baqar li kienu ttrattati fi studji kliniċi.
34 Do not use after the expiry date (EXP) stated on the carton and vial.
34 Tużax wara d- data ta ’ l- iskadenza (EXP) fuq il- kartuna u l- kunjett.
Precautions for use in animals If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Prekawzjonijiet għall- użu fl- annimali Jekk ikun hemm reazzjonijiet avversi, it- trattament għandu jitwaqqaf u għandu jittieħed il- parir ta ’ veterinarju.
Use during pregnancy and lactation Can be used during pregnancy and lactation.
Użu fit- tqala u fi żmien il- ħalib Jista ’ jintuża waqt it- tqala u t- treddigħ.
20, 50, 100 or 250 ml injection vials.
Kunjetti għall- injezzjoni, ta ’ 20, 50, 100 jew 250 ml.
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 għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) abbażi tad- dokumentazzjoni pprovduta, waslet għar- rakkomandazzjonijiet dwar il- kundizzjonijiet tal- użu.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Jekk teħtieġ aktar informazzjoni dwar il- kundizzjoni medika jew it- trattament tal- annimal tiegħek, ikkuntattja lill- veterinarju tiegħek.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq aktar informazzjoni relatata mar - rakkomandazzjonijiet tas- CVMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Onsior?
X’ inhu Onisor?
Onsior contains robenacoxib which belongs to a class of medicines that reduce fever, pain and inflammation.
Onsior fih robenacoxib, li jagħmel parti minn klassi ta ’ mediċini li jnaqqsu d- deni, l- uġigħ u l - infjammazzjoni.
It is available as tablets in five different strengths (6 mg for cats, and 5 mg, 10 mg, 20 mg and 40 mg for dogs) and as a solution for injection (20 mg/ ml for dogs and cats).
Huwa disponibbli f’ pilloli b’ ħames dożaġġi differenti (6 mg għall- qtates u 5 mg, 10 mg, 20 mg u 40 mg għall- klieb) u f’ soluzzjoni injettabbli (20 mg/ ml għall- klieb u l - qtates).
What is Onsior used for?
Għal xiex jintuża Onsior?
In cats, Onsior tablets are used for the treatment of acute pain and inflammation associated with musculoskeletal disorders (problems with the muscles and bones).
Fil- qtates, il- pilloli ta ’ Onsior jintużaw għat- trattament tal- uġigħ akut u tal- infjammazzjoni assoċjati ma ’ disturbi muskoloskeletriċi (problemi fil- muskoli u fl- għadam).
The solution for injection is used for the treatment of pain and inflammation associated with surgery of the soft tissues, such as neutering.
Is- soluzzjoni injettabbli tintuża għat- trattament tal- uġigħ u tal- infjammazzjoni assoċjati ma ’ interventi kirurġiċi tat- tessuti rotob, bħall- kastrazzjoni.
In dogs, Onsior tablets are used for the treatment of pain and inflammation associated with chronic osteoarthritis (a long-term disease causing pain in the joints).
Fil- klieb, il- pilloli Onsior jintużaw għat- trattament tal- uġigħ u tal- infjammazzjoni assoċjati mal- osteoartrite kronika (marda li ddum u tikkawża wġigħ fil- ġogi).
The solution for injection is used for the treatment of pain and inflammation associated with orthopaedic (bone) or soft tissue surgery.
Is- soluzzjoni injettabbli tintuża għat- trattament tal- uġigħ u tal- infjammazzjoni assoċjati ma ’ interventi ta ’ kirurġija ortopedika (tal- għadam) jew tat- tessuti rotob.
The tablets are given once a day at the same time every day, at a dose of 1 mg per kilogramme body weight with a range of 1-2 mg/ kg.
Il- pilloli jingħataw darba kuljum u fl- istess ħin kuljum, f’ doża ta ’ 1 mg għal kull kilo tal- piż tal- ġisem b’ limiti bejn 1 u 2 mg/ kg.
Treatment in cats is limited to six days.
It- trattament fil- qtates huwa limitat għal sitt ijiem.
Dogs should be treated for as long as is needed.
Il- klieb għandhom ikunu ttrattati għal perjodu ta ’ żmien meħtieġ.
The solution for injection is given to cats or dogs around 30 minutes before the start of the operation at a dose of 2 mg/ kg.
Is- soluzzjoni injettabbli tingħata lill- qtates jew lill- klieb madwar 30 minuta qabel ma jibda l - intervent f’ doża ta ’ 2 mg/ kg.
How does Onsior work?
Kif jaħdem Onsior?
The active substance in Onsior, robenacoxib, belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Is- sustanza attiva ta ’ Onsior, robenacoxib, tagħmel parti minn klassi ta ’ mediċi bl- isem mediċini antinfjammatorji mhux sterojdali (NSAIDs).
It works by blocking an enzyme called cyclo-oxygenase 2 (COX-2).
Is- sustanza taħdem billi timblokka enzima bl- isem ċiklossiġenażi 2 (cyclo- oxygenase 2, COX- 2).
This enzyme is involved in producing substances called prostaglandins, which are involved in pain and inflammation.
Din l- enzima hija involuta fil - produzzjoni ta ’ sustanzi msejħin prostaglandini li jipparteċipaw fl- uġigħ u fil- proċessi infjammatorji.
By blocking the production of prostaglandins, robenacoxib reduces the pain and inflammation caused by musculoskeletal disorders, surgery or osteoarthritis.
Billi jimblokka l- produzzjoni tal- prostaglandini, robenacoxib inaqqas l- uġigħ u l- infjammazzjoni kkawżati mid- disturbi muskoloskeletriċi, mill- interventi kirurġiċi jew mill - osteoartrite.
How has Onsior been studied?
Kif ġie studjat Onsior?
Onsior has been studied in laboratory animals, as well as ‘ clinical studies ’ in cats and dogs that were treated in veterinary practices and clinics across Europe.
Onsior ġie studjat fuq annimali ta ’ laboratorju u fi ‘ studji kliniċi ’ fuq qtates u klieb ittrattati fi prattiki u kliniki veterinarji fl- Ewropa.
In the clinical studies, Onsior was compared with other veterinary medicines containing NSAIDs (ketoprofen, meloxicam or carprofen).
Fl- istudji kliniċi, Onsior tqabbel ma ’ mediċini veterinarji oħra li fihom NSAIDs (ketoprofene, meloxicam jew carprofene).
The studies involved cats and dogs of different age groups, genders and breeds.
L- istudji involvew qtates u klieb ta ’ gruppi differenti ta ’ età, sess u razza.
The tablets were studied over five to six days in cats with acute musculoskeletal disorders and for up to one year in dogs with osteoarthritis.
Il- pilloli ġew studjati għal bejn ħamest ijiem u sitta fil- qtates b’ disturbi muskoloskeletriċi akuti u għal perjodu sa sena fil- klieb li jbatu minn osteoartrite.
The animals received the tablets once or twice a day.
L- annimali rċevew il- pilloli darba jew darbtejn kuljum.