qanastek/EMEA-V3 huggingface dataset:
Finally, it was shown that vaccination with Ibraxion did not induced antibodies against gE, allowing differentation between those animals and IBR infected ones.
Finalment, intwera li t- tilqima b’ Ibraxion ma induċietx anti- korpi kontra gE, b’ hekk tippermetti li ssir distinzjoni bejn dawk l- annimali u dawk infettati bl - IBR.
What are the side effects of Ibraxion?
X’ inhuma l- effetti sekondarji ta ’ Ibraxion?
The injection of Ibraxion may cause a temporary tissue reaction at the site of injection, which may last for three weeks and rarely up to five weeks.
L- injezzjoni ta ’ Ibraxion tista ’ tikkaġuna reazzjoni temporanja tat- tessut fil- post ta ’ l- injezzjoni, li tista ’ ddum għal tliet ġimgħat u f’ każijiet rari sa ħames ġimgħat.
Ibraxion may cause a slight rise in body temperature (less than 1°C) for less than 48 hours after injection.
Ibraxion jista ’ jikkaġuna żieda żgħira fit- temperatura (inqas minn 1°C) għal inqas minn 48 siegħa wara l- injezzjoni.
This does not affect the health or performance of the animal.
Dan ma jaffettwax is - saħħa jew il- prestazzjoni ta ’ l- annimal.
Rarely, a hypersensitivity (allergic) reaction may occur, which requires treatment.
F’ każijiet rari, tista ’ sseħħ reazzjoni ta ’ sensittività eċċessiva (allerġika), li teħtieġ trattament.
Ibraxion contains mineral oil.
Ibraxion fih żejt minerali.
The Package Leaflet should be taken to the doctor.
Il- Fuljett tat- Tagħrif għandu jittieħed lit- tabib.
If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.
Jekk l- uġigħ jippersisti għal aktar minn 12- il siegħa wara l- eżami mediku, it- tabib għandu jiġi kkuntattjat mill- ġdid.
Why has Ibraxion been approved?
Għaliex Ibraxion ġie approvat?
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Ibraxion are greater than any risks to immunise cattle to reduce the clinical signs of IBR and reduce field virus excretion.
Il- Kumitat għal Prodotti Mediċinali għal Użu Veterinarju (CVMP) qabel li l- benefiċċji ta ’ Ibraxion huma akbar minn kwalunkwe riskju li t- tilqima fil- baqar jista ’ jkollha biex jitnaqqsu s- sinjali kliniċi ta ’ l- IBR u jitnaqqas l- eskreta tal- virus fil- qasam.
They recommended that Ibraxion should be given a marketing authorisation.
Huma rrakkomandaw li Ibraxion għandu jingħata awtorizzazzjoni tal- kummerċ.
Other information about Ibraxion:
Tagħrif ieħor dwar Ibraxion:
The European Commission granted a marketing authorisation valid throughout the European Union, for Ibraxion to Merial on 9 March 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni tal- kummerċ valida madwar l- Unjoni Ewropea kollha, għal Ibraxion lil Merial fid- 9 ta ’ Marzu 2000.
Information on the prescription status of this product may be found on the labelling.
Tagħrif dwar l- istatus tal- preskrizzjoni ta ’ dan il- prodott jista ’ jinstab fuq it- tikketti.
This summary was last updated in 11-2006.
Dan is- sommarju kien aġġornat l- aħħar fi 11- 2006.
Target species
Speċi li fuqhom għandu jintuża l- prodott
Tablet
1 mg
Dogs
Pilloli
Blister
Kull strixxa
30 tablets
30 pinnola
Box containing N/ a 1 blister
Kaxxa tal - kartun bi strixxa waħda
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 Incurin?
X’ inhu Incurin?
Incurin is a tablet containing the natural hormone estriol as active substance.
Incurin huwa pillola li fih l- ormon naturali estriol bħala sustanza attiva.
What is Incurin used for?
Għal x' hiex jintuża Incurin?
Incurin is used for the treatment of hormone-dependent urinary incontinence resulting from sphincter mechanism incompetence (SMI) in ovariohysterectomised bitches (i. e. in dogs having had the ovaries and uterus removed surgically).
Incurin jintuża għat- trattament ta ’ inkontinenza urinarja dipendenti mill- ormon li tirriżulta minn inkompetenza fil- mekkaniżmu sphincter (SMI) fi klieb nisa li huma ovarjoisterektomizzati (jiġifieri fi klieb li jkunu tneħħewlhom l- ovarji u l- utru permezz ta ’ intervent kirurġiku).
As the sensitivity of incontinent dogs to estriol is variable, the dose has to be determined on an individual basis.
Minħabba li s- sensittività tal- klieb inkontinenti tvarja, id- doża trid tiġi ddeterminata fuq bażi individwali.
For advise on dosing please see the Package Leaflet.
Għal parir dwar id- dożaġġ jekk jogħġbok ara l- Fuljett ta ’ Tagħrif.
How does Incurin work?
Kif jaħdem Incurin?
Estriol contained in Incurin is a short-acting natural oestrogen which binds to the oestrogen receptor.
Estriol li jinsab f’ Incurin huwa estroġenu naturali li jaġixxi għal żmien qasir li jingħaqad mar - riċettur ta ’ l- estroġenu.
The term urinary incontinence is used to describe the condition of involuntary leakage of urine.
It- terminu inkontinenza urinarja huwa wżat biex jiddeskrivi l- kundizzjoni ta ’ tnixxija mhux volontarja ta ’ l- awrina.
It is known to occur in bitches, with the incidence being highest after ovariectomy.
Huwa magħaruf li dan isseħħ fil- klieb nisa, speċjalment wara li tkun saritilhom ovarjektomija.
This condition is accompanied with a decrease of the endogenous oestrogen production.
Din il- kundizzjoni ġġib magħha tnaqqis fil- produzzjoni ta ’ l- estroġenu endoġeniku.
Scientific findings strongly suggest a relationship between the incidence of urinary incontinence and oestrogen depletion.
Sejbiet xjentifiċi jissuġġerixxu fermament li teżisti relazzjoni bejn l- inkontinenza urinarja u t- tnaqqis ta ’ l- estroġenu.
Oestrogen receptors can be found in the urethral sphincter, where oestrogens induce a full response, this way improving urethral closure and bladder storage.
Ir- riċetturi ta ’ l- estroġenu jistgħu jinstabu fi spinchter ta ’ l - uretra, fejn l- estroġenu jinduċi rispons sħiħ, fejn b’ dan il- mod itejjeb l- għeluq ta ’ l- uretra u l- ħżin fil- bużżieqa ta ’ l- awrina.
How has Incurin been studied?
Kif ġie studjat Incurin?
Incurin has been studied in bitches in three large field trials.
Incurin ġie studjat fil- klieb nisa fi tliet provi kbar fuq il- post.
During the studies repeated administration of up to 2mg estriol per dog produced beneficial effects in bitches showing involuntary leakage of urine.
Matul l- istudji, ingħataw ripetutament dożi sa 2mg ta ’ estriol għal kull kelb u dawn produċew effetti benefiċi fil- klieb nisa li wrew tnixxija mhux volontarja ta ’ l- awrina.
The studies also established that there is no apparent relationship between the dosage and the body weight of the dog – therefore the dosing has to be decided on an individual basis.
L- istudji stabilixxew ukoll li ma kien hemm l- ebda relazzjoni apparenti bejn id- dożaġġ u l- piż tal- ġisem tal- kelb - għalhekk id- dożaġġ irid jiġi deċiż fuq bażi individwali.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu © European Medicines Agency, 2008.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu © European Medicines Agency, 2008.
What benefit has Incurin shown during the studies?
Liema benefiċċju wera Incurin waqt l- istudji li ġew mwettqa?
The majority of bitches involved in the studies responded positively: they became continent, and remained that way in the long term.
Il- biċċa l- kbira tal- klieb nisa involuti fl- istudji irrispondew b’ mod pożittiv. dawn saru kontinenti, u baqgħu hekk għal medda ta ’ żmien twil.
The results show that Incurin is efficient and safe to use against urinary incontinence due to SMI in ovariohysterectomised dogs.
Ir- riżultati wrew li Incurin huwa effiċjenti u sigur għall- użu kontra l- inkontinenza urinarja dovuta għal SMI fi klieb li ġew ovarjoisterektomizzati.
What is the risk associated with Incurin?
X’ inhu r- riskju assoċjat ma ’ Incurin?
Incurin is not to be used in intact bitches, as the efficacy has only been established in ovariohysterectomised bitches.
Incurin m’ għandux jintuża fi klieb nisa li ma jkunux intmessu, minħabba li l- effikaċja ġiet stabbilita biss fi klieb nisa li ġew ovarjoisterektomizzati.
Animals showing a polyuria-polydipsia (excessive water intake and consequent excretion of a large volume of urine) should also not be treated with this product.
L- annimali li wrew poljurija polidipsja (polyuria polydipsia) (teħid eċċessiv ta ’ ilma u t- tneħħija konsegwenti ta ’ volum kbir ta ’ awrina) m’ għandhomx jiġu trattati b’ dan il- prodott.
Effects typical to oestrogens such as swollen vulva, swollen mammary glands and/ or attractiveness to males and vomiting have been observed at the highest recommended dose of 2 mg per dog.
Effetti tipiċi għall- estroġenu bħall- infjammazzjoni tal- vulva, tal- glandoli tal- ħalib u/ jew kemm jiġbdu l- klieb maskili u remettar ġew osservati fl- iktar doża għolja rakkomandata ta ’ 2mg kull kelb.
The incidence is about 5-9%.
L- inċidenza hija ta ’ madwar 5. 9%.
These effects are reversible after lowering the dose.
L- effetti huma reversibbli wara t- tnaqqis fid- doża.
In rare cases vaginal bleeding occurred.
F’ każijiet rari seħħ ukoll ħruġ ta’ demm mill- vaġina.
In very rare cases development of alopecia (loss of hair) has also been observed.
F’ każijiet rari ħafna ġie wkoll osservat żvilupp ta ’ alopekja (telf ta ’ xagħar).
No special precautions are necessary when administering Incurin.
L- ebda prekawzzjoni speċjali m’ hija meħtieġa meta jingaħta Incurin.
Why has Incurin been approved?
Għaliex ġie approvat Incurin?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Incurin excede the risks for the treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in ovariohysterectomised bitches, and recommended that Incurin be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veternarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Incurin huma ikbar mir- riskji għat- trattament ta ’ inkontinenza urinarja dipendenti mill - ormon dovuta għal inkompetenza tal- mekkaniżmu sphincter fil- klieb nisa li ġew ovarjoisterektomizzati u rrakkomanda li Incurin jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Incurin:
Tagħrif ieħor dwar Incurin:
The European Commission granted a marketing authorisation valid throughout the European Union for Incurin to Intervet International B. V. on 24 March 2000 and renewed in it 2005.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea għal Incurin lil Intervet International B. V. fl- 24 ta ’ Marzu tas- sena 2000 u din ġiet imġedda fl- 2005.
Information on the prescription status of this product may be found on the label/ outer package.
L- Informazzjoni dwar l- istat tal- preskrizzjoni ta ’ dan il- prodott tista ’ tiġi kkonsultata fuq it- tikketta jew fuq il- qoxra tal- pakkett.
This summary was last updated in April 2008.
Dan is- sommarju ġie aġġornat l- aħħar f’ April 2008.
1/ 15 1.
1/ 17 1.
INCURIN 1 mg tablet
Incurin pilloli ta 'milligramma
Active substance: estriol 1 mg/ tablet For a full list of excipients, see section 6.1
1 mg estriol kull pillola Għall- lista sħiħa ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1
Tablet Round single-scored tablets.
Pilloli Pilloli tondi b’ sinjal wieħed fin nofs.
4.1 Target Species
4. 1 Speċi li l- prodott għandu jintuża fuqhom
Dogs (bitches).
Klieb tas- sess femminili
The treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in ovariohysterectomised bitches.
Trattament ta ’ inkontinenza dipendenti fuq l- ormoni fi klieb femminili, minħabba sfinkter li m’ għadux tajjeb wara ovario- isterektomija
Do not use in intact bitches, as the efficacy has only been established in ovariohysterectomised bitches.
Tużax fi klieb nisa li ma ġewx operati, minħabba li l- effikaċja tal- prodott ġiet stabbilita biss f’ kelbat li saritilhom ovarjo- isterektomija.
Animals showing a polyuria-polydipsia should not be treated with Incurin.
Klieb li juru sintomi ta ’ għatx u urinar kontinwu m’ għandhomx jiġu trattati bl- Incurin.
The use of Incurin is contraindicated during pregnancy and in animals younger than 1 year.
L- użu tal- Incurin m ’ għandux jintuża waqt it- tqala jew f’ annimali ta’ anqas minn sena.
High doses of oestrogen may have a tumour-promoting effect in target organs with oestrogen receptors (mammary glands).
Dożi għolja ta ’ estroġeni, jistgħu jikkawżaw tumuri f’ organi li jaħdmu fuqhom l- estroġeni (bħal fis- sider).
Special precautions for use in animals In case of oestrogenic effects, the dose should be lowered.
F’ każ ta ’ effetti estroġeniċi, id - doża għandha titnaqqas.
Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable.
2/ 17 Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali lill - annimali
Oestrogenic effects such as swollen vulva, swollen mammary glands and/ or attractiveness to males and vomiting have been observed at the highest recommended dose of 2 mg per dog.
Effetti estroġeniċi, bħal vulva u sider minfuħ, namra żejda u remettar ġew osservati fl- ogħla doża ta ’ 2 mg kull kelb.
The incidence is about 5- 9%.
L- inċidenza hija ta ’ madwar 5 - 9%.
These effects are reversible after lowering the dose.
Dawn l - effetti huma riversibbli wara li titnaqqas id- doża.
In rare cases vaginal bleeding occurred.
F’ każi rari, ġieli kien hemm telf ta ’ demm mill- vaġina.
In very rare cases development of alopecia has also been observed.
F’ każi rari ħafna, telf ta ’ pil ġie osservat.
2/ 15 4.7 Use during pregnancy, lactation or lay
4. 7 Użu fit- Tqala u fi żmien il- ħalib
4.9 Amount(s) to be administered and administration route
4. 9 Doża rakkomandata u l- metodu ta ’ amministrazjoni
For oral administration.
Amministrazjoni mill- ħalq.
A relationship between final effective dose and body weight has not been established and therefore the dose has to be determined for each dog on an individual basis.
Ir- relazzjoni bejn doża finali effettiva u l- piż tal- kelba għadu ma ġiex stabbilit u għalhekk id - doża trid tiġi determinata individwalment għal kull kelba.
The following dosing schedule is advised: start treatment with 1 tablet (1 mg estriol) every day.
Din l- iskema ta ’ dożaġġi hija rakkomandata: ibda t- trattament b’ pillola waħda (milligramma ta ’ estriol) kuljum.
If treatment is successful, lower the dose to half a tablet a day.
Jekk it - trattament jaħdem naqqas id- doża bin- nofs.
If treatment is not successful, increase the dose to 2 tablets a day to be given in one dose.
Jekk it- trattament ma jaħdimx, żid id- doża għal 2 pilloli f’ salt kuljum.
Some dogs do not need daily treatment; treatment every other day may be tried, once the effective daily dose has been established.
Xi klieb ma jkollhomx bżonn trattament ta ’ kuljum; tista ’ tipprova titratta ġurnata iva u ġurnata le, ladarba d- doża effettiva tkun ġiet stabbilita.
The minimum dose given should not be less than 0.5 mg per dog per day.
L - inqas doża qatt ma għanda tkun inqas minn 0. 5 milligrammi għal kull kelba kuljum.
Ensure the dose used to achieve the therapeutic effect is as low as possible.
Kun żgur li d- doża użata sabiex ikun hemm effett terapewtiku hija baxxa kemm jista ’ jkun.
Do not use more than 2 tablets per dog per day.
Tużax aktar minn żewġ pinnoli għal kull kelba kuljum.
If no response to treatment is obtained the diagnosis should be reconsidered in order to investigate other causes for the incontinence such as neurological disorders, bladder neoplasia, etc.
Jekk it- trattament ma jaħdimx, wieħed għandu jerġa ’ jikkunsidra d- dijanjosi u jinvestiga kawżi oħra tal- inkontinenza bħal diżordnijiet newroloġiċi, neoplasja fil- bużżieqa tal- awrina …..
Animals should be re-examined every 6 months during treatment.
Il - kelba għandha tiġi eżaminata kull 6 xhur waqt it- trattament.
In case of overdose typical oestrogen effects may occur.
F’ kazi ta ’ dożi eċċessivi se jkun hemm effetti tipiċi estroġeniċi.
These effects are reversible after lowering the dose.
Dawn l- effetti huma riversibbli meta d - doża titnaqqas.
4.11 Withdrawal periods
4. 11 Perjodu ta ’ Tiżmim
Pharmacotherapeutic group: estrogens, ATCvet code:
Klassi farmakoterapewtika: estoġeni Kodici ATĊ veterinarja:
5.1 Pharmacodynamic properties
3/ 17 5. 1 Kwalitajiet farmakodinamici
Estriol is a short-acting natural oestrogen.
Estriol huwa estroġenu naturali li jaħdem farmakoloġikament għal żmien qasir.
In the target animal safety study and the clinical trials, including long-term treatment, no signs of bone marrow suppression were observed.
Fi studji li saru dwar il - ħarsien tas- saħħa ta ’ l- annimali li għalihom huwa indikat il- prodott u fi studji kliniċi anke dwar trattament fit- tul, ma ġew osservati l- ebda sinjali ta 'tnaqqis fl- attivita ta ’ l- mudullun tal- għadam.
This is probably due to the short-acting oestrogenic character of estriol.
Dan aktarx huwa minnhabba li estriol jaħdem farmakoloġikament għal żmien qasir.
5.2 Pharmacokinetic particulars
5. 2 Kwalitajiet farmakokinetici
After oral administration of multiple doses no accumulation occurs.
Meta jingħata mill- ħalq bosta drabi ma jakkumulax.
6.1 List of excipients
6. 1 Sustanzi mhux attivi
Amylopectin Potato starch Magnesium stearate
Amilopektin Lamtu tal- patata Stirejt tal- magneżju Lattożju
6.2 Imcompatibilities
6. 2 Inkompatibilitajiet
Do not store above 30°C.
Taħżinx f' temperaturi ogħla minn 30°Ċ
6.5 Nature and composition of immediate packaging
6. 5 In- natura tal- materjal tal- kontenitur u ta ’ dak li hemm ġo fih
Blister package of clear PVC film backed by aluminium foil provided with heat seal coating (vinyl copolymer) on the side in contact with the tablets.
Strixxi ta ’ PVC ċar u minn wara b’ folja tal- aluminjum b’ kisja ssiġillata ta ’ (vinyl copolymer) fin- naħa ta ’ fejn imissu l- pinnoli.
One blister contains 30 tablets.
Kull strixxa fiha 30 pillola.
Pack size: carton box with 1 blister
6. 6
6.6 Special precautions for the disposal of unused medicinal product or waste materials derived from the use of such products
Prekawzjonijiet speċjali għar- rimi tal- mediċina mhux użata jew materjal ta ’ skart derivat, mill- użu tal- prodott
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 gietx użata jew prodotti oħra li ntużaw għal din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiz.
MARKETING AUTHORISATION HOLDER
ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
WIM DE KORVERSTRAAT 35 5831 AN BOXMEER OLANDA.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
Data tal- ewwel Awtorizzazzjoni / Tiġdid tal- Awtorizzazzjoni
March 2000 Date of renewal of the authorisation:
Marzu 2000 Data ta ’ tiġdid tal- awtorizzazzjoni:
February 2005
Frar 2005
4/ 15 ANNEX II
5/ 17 ANNESS II
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND 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 AND USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L - AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL- PROVISTA JEW L- UŻU
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
OBLIGAZZJONIJIET SPEĊIFIĊ LI JRIDU JIĠU MĦARSA MIS- SID TA ’ L - AWTORIZZAZZJONI TAL- KUMMERĊ
5/ 15 A.
6/ 17 A.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTURA( I) TAS- SUSTANZA( I) BIOLOĠIKA( ĊI) ATTIVA( I) U > SID (/ S- SIDIEN TA ’) L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
Name and address of the manufacturer(s) of the biological active substance(s)
Isem u indirizz tal- manufattur( i) tas- sustanza( i) bioloġika( ċi) attiva( i)
Organon Kloosterstraat 6 5349 AB Oss The Netherlands
N. V. Organon Kloosterstraat 6 5349 AB Oss Olanda
To be supplied only on veterinary prescription.
Prodott mediċinali veterinarju li jingħata biss b’ riċetta veterinarja.
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
OBLIGAZZJONIJIET SPEĊIFIĊI LI JRIDU JIĠU MĦARSA MIS- SID TA ’ AWTORIZZAZZJONI TAL- KUMMERĊ
6/ 15 ANNEX III
7/ 17 ANNESS III
LABELLING AND PACKAGE INSERT
TIKETTA U L- FULJETT TA ’ TAGĦRIF FIL- PAKETT
7/ 15 A.
8/ 17 A.
8/ 15 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
9/ 17 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
INCURIN 1 mg tablet Estriol
Incurin pinnoli ta ’ milligramma
Active substance: estriol 1 mg/ tablet
Sustanza attiva: estriol, 1 mg / pinnola
Tablet.
Pinnoli
Each blister contains 30 tablets.
Kaxxa tal- kartun bi strixxa waħda. Kull strixxa fiha 30 pinnola.
Dog.
Klieb tas- sess femminili
Dosage and administration: see enclosed leaflet.
Mill- ħalq Doża rakkomandata u l- metodu ta ’ amministrazzjoni: ara l- fuljett ta’ ġewwa.
Exp (Month/ year)
Jiskadi {xahar / sena}
Do not store above 30°C.
Taħżinx f' temperatura l- fuq minn 30°Ċ
SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY
TAGĦRIF DWAR IR- RIMI TA 'MEDIĊINA MHUX UŻATA JEW MATERJAL ĦAŻIN IEĦOR, JEKK IKUN IL- KAŻ
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM "GĦAL TRATTAMENT TA ’ L- ANNIMALI BISS ” U KONDIZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVISTA U L- UŻU, jekk applikabbli
For animal treatment only.
Għat- trattament tal- annimali biss.
To be supplied only on veterinary prescription.
Jingħata biss fuq riċetta veterinarja.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
L- ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ, U L - ISEM U L- INDIRIZZ TAS- SID TAL - AWTORIZZAZJONI TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L- KONSENJA TMUR FIS- SUQ FL- EEA, JEKK HUWA DIFFERENTI
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Wim de Korverstraat 35 5831 AN Boxmeer The Netherlands
MARKETING AUTHORISATION NUMBER(S)
NUMRU TAL- AWTORIZZAZJONI GĦALL- KUMMERĊ FIR- REĠISTRU TAL - KOMUNITA
MA number.
numru MA
17.
11/ 17 17.
Batch number.
lott
10/ 15 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
12/ 17 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ZGĦAR
Blister of 30 tablets
Strixxa ta 30 pillola
INCURIN 1 mg tablet
Incurin pilloli ta ’ milligramma
NAME OF THE MARKETING AUTHORISATION HOLDER
L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL - KUMMERĊ:
(Month / year)
{xahar/ sena}
Batch number.
Lott {numru}
For animal treatment only.
Għat- Trattament ta ’ l- Annimali biss.
11/ 15 B.
13/ 17 B.
PACKAGE INSERT
FULJETT TA 'TAGĦRIF
12/ 15 Package leaflet Incurin 1 mg tablet
14/ 17 Fuljett ta ’ tagħrif Incurin pillola ta’ milligramma
NAME AND ADDRESS OF THE MARKETING AUTHORSATION HOLDER AND OF THE MANUFACTURING AUTORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
L- ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZJONI TAL- KUMMERĊ, U L - ISEM U L- INDIRIZZ TAS- SID TA ’ L - AWTORIZZAZJONI TAL- MANIFATTURA RESPONSABBLI, JEKK HUWA DIFFERENTI
Marketing authorisation holder
Tas- sid ta’ l- awtorizzazjoni tal- kummerċ
Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Intervet International B. V Wim De Korverstraat 35 5831 AN Boxmeer Olanda
Manufacturer for the batch release
Manifattur responsabli mil- lott
Organon Kloosterstraat 6 5349 AB Oss The Netherlands
Organon Kloosterstraat 35 5831 AN Boxmeer Olanda
INCURIN 1 mg tablet Estriol
Pilloli Incurin ta ’ milligramma
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
DIKJARAZZJONI TAS- SUSTANZA ATTIVA U SUSTANZI OĦRA
Active substance: estriol 1 mg/ tablet Round single-scored tablets.
Sustanza attiva: Estriol 1mg / pillola Pinnoli tondi b’ sinjal wieħed fin nofs.
Incurin is indicated for the treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in female dogs.
Trattament ta ’ inkontinenza dipendenti fuq l- ormoni fi klieb femminili, minħabba sfinkter li m’ għadux tajjeb.
The use of Incurin is contraindicated during pregnancy and in animals younger than 1 year.
L- użu tal- Incurin ma għandux jintuża waqt it- tqala jew f’ annimali ta’ anqas minn sena.
Mild, oestrogenic effects such as swollen vulva, swollen teats and/ or attractivity for males have been observed at the high dose of 2 mg.
Effetti ħfief estroġeniċi, bħal vulva u sider minfuħ, namra żejda u remettar ġew osservati fl- ogħla doża ta 2 mg kull kelb.
Further, in some dogs, symptoms of nausea were observed.
Sintomi ta ’ dardir ġew osservati
13/ 15 In rare cases vaginal bleeding occurred.
15/ 17 f’ xi klieb.
In very rare cases development of alopecia has also been observed.
F’ każi rari, ġieli kien hemm telf ta ’ demm mill- vaġina.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Jekk tinnota x’ effett gravi mhux mixtieq jew x’ effetti oħra mhux imsemmija f’ dan il fuljett, informa lil veterinarju.
TARGET SPECIES
SPEĊI GĦAL X' HIEX HUWA NDIKAT
Dog.
Klieb
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
DOŻA GĦAL KULL SPEĊI u l- metodu ta ’ amministrazzjoni
Incurin is intended for once daily oral administration.
Incurin jingħata mill- ħalq darba kuljum.
The dose has to be fixed for each dog on an individual basis.
Ir- relazzjoni bejn doża finali effettiva u l- piż tal- kelba għadu ma ġiex stabbilit u għalhekk id - doża trid tiġi determinata individwalment għal kull kelba.
The following dosing schedule is advised: start treatment with 1 tablet every day.
Din l- iskema ta ’ dożaġġi hija rakkomandata: ibda t- trattament b’ pillola waħda (milligramma ta ’ estriol) kuljum.
If treatment is successful lower the dose to half a tablet a day.
Jekk it - trattament jaħdem naqqas id- doża bin- nofs.
If treatment is not successful increase the dose to 2 tablets a day.
Jekk it- trattament ma jaħdimx, żid id- doża ghal 2 pinnoli f’ salt kuljum.
Some dogs do not need daily treatment; treatment every other day may be tried once the effective daily dose has been established.
Xi klieb ma jkollhomx bżonn trattament ta ’ kuljum; tista ’ tipprova titratta ġurnata iva u ġurnata le, ladarba d- doża effettiva tkun ġiet stabbilita.
ADVICE ON CORRECT ADMINISTRATION
PARIRI DWAR AMMIINISTRAZZJONI KORETTA
SPECIAL STORAGE CONDITIONS
TAGĦRIF SPEĊJALI DWAR KIF GĦANDU JINĦAZEN
Do not use after the expiry date which is stated on the label.
Taħżinx f' temperaturi ogħla minn 30°Ċ Ma għandux jintuża wara d- data ta’ l- iskadenza indikata fuq it- tiketta.
High doses of oestrogen may have a tumor-promoting effect in target organs with oestrogen receptors (mammary glands).
Dożi għolja ta ’ estroġeni, jistgħu jikkawżaw tumuri f’ organi li jaħdmu fuqhom l- estroġeni (bħal fis- sider).
In case of overdose typcial oestrogen effects may occur.
F’ kazi ta ’ dożi eċċessivi se jkun hemm effetti tipiċi estroġeniċi.
These effects are reversible after lowering the dose.
Dawn l- effetti huma riversibbli meta d - doża titnaqqas
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TAL- MEDIĊINA MHUX UŻATA JEW MATERJAL TA ’ SKART IEĦOR DERIVAT MILL- UŻU TAL- PRODOTT JEKK IKUN HEMM.
Ask your veterinary surgeon how to dispose of medicines no longer required.
Saqsi lil veterinarju dwar kif tarmi mediċini li ma għadx hemm bżonnhom.
These measures should help to protect the environment.
Dawn il- miżuri għandhom jgħinu fil- ħarsien tal- ambjent.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
DATA META ĠIE APPROVAT L- AĦĦAR IL- FULJETT INFORMATTIV FIL- PAKKETT
Each push-through strip contains 30 tablets.
Kull strixxa fiha 30 pillola.
Each strip is packed in a carton box.
Kull strixxa hija ppakjata f’ kaxxa tal- kartun.
Oestriol is a short-acting natural oestrogen.
Estriol huwa estroġenu naturali li jaħdem għal żmien qasir.
Upon oral administration a steady state is reached after the second treatment day and no accumulation occurs after multiple dosing.
Għandu effett tajjeb fuq inkontinenza fi klieb femminili li jbatu minn din l- kundizzjoni. Il- mediċina tilħaq konċentrazzjoni stabbli fid- demm wara t- tieni ġurnata ta’ trattament li ma takkumulax wara dożi ripetuti.
Because of its short acting action, oestriol does not induce bone marrow suppression in the dog.
Minnħabba li - estriol jaħdem farmakoloġikament għal żmien qasir ma jikkawżax tnaqqis fl- attivita tal- mudullun tal- ghadam fil - klieb.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Għal kull tip ta’ informazzjoni fuq dan il- prodott veterinarju, agħmel kuntatt mar - rappreżentat lokali tas Sid tal- Awtorizzazzjoni tal Kummerċ..
15/ 15
17/ 17
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 magħmula mill- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) abbażi tad- dokumentazzjoni pprovduta, wasslet għar- rakkomandazzjonijiet dwar il- kundizzjonijiet ta ’ l- użu.
This document cannot replace a face-to-face discussion with your veterinarian.
Dan id- dokument ma jistax jieħu post diskussjoni wiċċ imb’ wiċċ mal- veterinarju tiegħek.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Jekk teħtieġ iktar informazzjoni dwar il- kundizzjoni medika jew dwar it - trattament ta ’ l- 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 iktar informazzjoni abbażi tar- rakkomandazzjonijiet tal- CVMP, aqra d- Diskussjoni Xjentifika (parti wkoll mill- EPAR).
What is Ingelvac CircoFLEX?
X’ inhu CircoFLEX?
Ingelvac CircoFLEX is a vaccine for use in pigs, which is available as a suspension for injection.
Ingelvac CircoFLEX huwa vaċċin għall- użu fil- ħnieżer, li jiġi bħala sospensjoni għall - injezzjoni.
It contains a protein (antigen) from the porcine circovirus type 2 virus (PCV2).
Fih proteina (antiġene) miċ- ċirkovajrus tal- ħnieżer tat- tip 2 (PCV2).
The vaccine does not contain any live PCV2 and the antigen cannot replicate in the animal.
Il- vaċċin ma fihx PCV2 ħaj u l- antiġene ma jistax jimmultiplika fl- annimal.
What is Ingelvac CircoFLEX used for?
Għalxiex jintuża CircoFLEX?
Ingelvac CircoFLEX is used to vaccinate pigs from two weeks of age against PCV2 infection.
Ingelvac CircoFLEX jintuża għat- tilqim tal- majjali ta ’ ġimagħtejn jew iktar għal kontra l - infezzjoni PCV2.
This helps to reduce deaths, signs of disease such as weight loss, and damage to lymphoid tissue associated with this infection.
Dan jgħin fit- tnaqqis tal- mortalità, sinjali tal- mard bħal telf fil- piż, u ħsara fit- tessuti linfojdi assoċjata ma ’ din l- infezzjoni.
It can also reduce shedding of the virus from the nose, the level of the virus in the blood and lymphoid tissue, and the duration of blood infection (viraemia) with the virus.
Jista ’ jnaqqas ukoll it- tnixxija tal- virus mill - imnieħer, il- livell tal- vajrus fid- demm u t- tessut linfojde, kif ukoll il- perjodu kemm iddum l - infezzjoni tad- demm mill- vajrus (viremija).
The vaccine is given by injection into a muscle.
Il- vaċċin jista ’ jingħata b’ injezzjoni f’ muskolu.
Onset of protection against PCV2 occurs from as early as two weeks after the injection and lasts for at least 17 weeks.
Il- protezzjoni kontra l- PCV2 sseħħ sa minn ġimagħtejn wara l- injezzjoni u ddum ta ’ l- anqas 17- il ġimgħa.
How does Ingelvac CircoFLEX work?
Kif jintuża CircoFLEX?
Porcine circovirus type 2 (PCV2) is known to cause a wide variety of clinical signs and syndromes in pigs, some of which may be caused by PCV2 in combination with other agents.
Iċ- ċirkovajrus tal- ħnieżer tat- tip 2 (PCV2) huwa magħruf li jikkawża varjetà kbira ta ’ sinjali u sindromi kliniċi fil- ħnieżer, li wħud minnhom jistgħu jkunu kkawżati mill- PCV2 flimkien ma ’ sustanzi oħra.
PCV2 associated infections may include symptoms such as weight loss or failure to grow, enlarged lymph nodes, difficulty breathing, diarrhoea, pale skin and jaundice (yellowing of the skin).
L- infezzjonjiet ikkawżati mill- PCV2 jistgħu jinkludu sintomi bħal telf fil- piż jew in- nuqqas tal- kobor, linfonodi minfuħa, tbatija biex wieħed jieħu n- nifs, dijarrea, ġilda bajdnija u suffejra (ġilda safranija).
Ingelvac CircoFLEX is a vaccine.
Ingelvac CircoFLEX huwa vaċċin.
Ingelvac CircoFLEX contains small amounts of a protein from PCV2.
Ingelvac CircoFLEX fih ammont żgħir ta ’ proteina mill- PCV2.
When a pig is given the vaccine, the pig’ s immune system recognises the protein as ‘ foreign’ and reacts by building up an active immune response.
Meta ħanżir jingħata l- vaċċin, is- sistema immunitarja tal- ħanżir tagħraf lill- proteina bħala waħda ‘ barranija ’ u tirreaġixxi billi jibda rispons immunitarju attiv.
In the future, the immune system will be able to react against the virus more quickly when it is exposed to the virus.
Fil- futur, is- sistema immunitarja tkun tista ’ tirreaġixxi kontra l- vajrus iktar malajr meta tkun esposta għall- vajrus.
This active immune response will help to protect the pig against the disease caused by this virus.
Dan ir- rispons immunitarju attiv jgħin fil- protezzjoni tal- ħanżir kontra l- marda kkawżata minn dan il- vajrus.
Reproduction is authorised provided the source is acknowledged How has Ingelvac CircoFLEX been studied?
Reproduction is authorised provided the source is acknowledged Kif ġie studjat CircoFLEX?
Ingelvac CircoFLEX has been studied in a number of trials involving pigs of various breeds.
Ingelvac CircoFLEX ġie studjat f’ għadd ta ’ studji bis- sehem ta ’ ħnieżer ta ’ diversi razez.
These studies have been performed under laboratory as well as under typical European farming conditions.
Dawn l- istudji saru f’ kundizzjonijiet tal- laboratorju u f' kundizzjonijiet ta 'trobbija tal- bhejjem tipikament preżenti fl- Ewropa.
The main measure of effectiveness was the rate of weight gain in the vaccinated pigs, but the studies also looked at other parameters including symptoms, the level of PCV2 in the blood and the number of runts.
Il- mezz ewlieni tal- kejl ta ’ l- effikaċja kien ir- rata ta ’ żieda fil - piż fil- ħnieżer imlaqqma, iżda l- istudji ħarsu wkoll lejn il- parametri inkluż is- sintomi, il- livell tal- PCV2 fid- demm u l- għadd ta 'eżemplari li jkunu iżgħar mid- daqs normali (runts).
What benefit has Ingelvac CircoFLEX shown during the studies?
X’ inhu l- benefiċċju ta ’ CircoFLEX li ntwera f’ dawn l- istudji?
The trials showed that vaccination of pigs with Ingelvac CircoFLEX reduced weight loss in the piglets.
L- istudji wrew li t- tilqim tal- ħnieżer b’ Ingelvac CircoFLEX naqqas it- telf ta ’ piż fid- driefeġ.
It also reduced the levels of PCV2 in the blood, symptoms of PCV2 infection, the number of runts and death rates.
Naqqas ukoll il- livelli tal- PCV2 fid- demm, is- sintomi ta ’ l- infezzjoni tal- PCV2, l- għadd ta 'eżemplari li jkunu iżgħar mid- daqs normali u r- rata tal- mortalità.
What is the risk associated with Ingelvac CircoFLEX?
X’ inhu r- riskju assoċjat ma ’ CircoFLEX?
Ingelvac CircoFLEX can cause a mild, temporary increase in body temperature, usually on the day of vaccination.
Ingelvac CircoFLEX jista ’ jikkawża żieda ħafifa u temporanja fit- temperatura tal- ġisem, ġeneralment fil- jum tat- tilqima.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
X’ inhuma l- prekawzjonjiet għall- persuna li tagħti l- mediċina jew tiġi f’ kuntatt ma ’ l- annimal?
There are no special precautions for the person who gives Ingelvac CircoFLEX or comes into contact with the animal.
M’ hemmx prekawzjonijiet speċjali għall- persuna li tagħti Ingelvac CircoFLEX jew li tiġi f’ kuntatt ma ’ l- annimal.
What is the time allowed before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Kemm irid jgħaddi ħin qabel ma l- animal ikun jista ’ jinqatel u l- laħam tiegħu jintuża għall - konsum mill- bniedem (perjodu ta 'rtirar)?
The withdrawal period is zero days.
Il- perjodu ta ’ rtirar huwa ta ’ 0 ġranet.
Why has Ingelvac CircoFLEX been approved?
Għaliex ġie approvat CircoFLEX?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Ingelvac CircoFLEX exceed the risks for the active immunisation of pigs, over the age of two weeks, against PCV2, and recommended that Ingelvac CircoFLEX be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinajru (CVMP) ikkonkluda li l- benefiċċji ta ’ Ingelvac CircoFLEX jegħlbu lir- riskji għat- tilqima attiva tal- ħnieżer ta ’ iktar minn ġimagħtejn, kontra l- PCV2, u rrakkomanda li Ingelvac CircoFLEX 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 jista ’ jinstab fil- modulu 6 ta ’ dan l - EPAR.
Other information about Ingelvac CircoFLEX:
Informazzjoni oħra dwar Ingelvac CircoFLEX:
The European Commission granted a marketing authorisation valid throughout the European Union for Ingelvac CircoFLEX to Boehringer Ingelheim Vetmedica GmbH on 13 February 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Ingelvac CircoFLEX lil Boehringer Ingelheim Vetmedica GmbH fit- 13 ta ’ Frar 2008.
Information on the prescription status of this product may be found on the outer package.
Informazzjoni dwar l- istatus tal- preskrizzjoni ta ’ dan il- prodott tista ’ tinstab fuq l - imballaġġ estern.
This summary was last updated on 13 February 2008.
Dan is- sommarju ġie aġġornat l- aħħar fit- 13 ta ’ Frar 2008.
EU - Number
Numru ta ’ l- UE
Target Species
Speċi li fuqhom għandu jintuża l- prodott
Withdrawal period
Perjodu ta ’ tiżmim
Porcine circovirus type 2 ORF2 protein Minimum RP 1.0, Maximum RP 3.75
ORF2 proteina
Suspension for injection
Suspensjoni
Bottle (HDPE)
Flixkun
1 bottle
1 flixkun
Ingelvac CircoFLEX suspension for injection for pigs
Ingelvac CircoFLEX suspensjoni għall- injezzjoni għal qżieqeż
Each dose of 1 ml of inactivated vaccine contains:
Kull doża ta ’ 1 ml ta ’ tilqima diżattivata fiha:
Porcine circovirus type 2 ORF2 protein: minimum RP* 1.0 maximum RP* 3.75 * Relative Potency (ELISA test) by comparison with a reference vaccine
circovirus tal- qżieqeż ta ’ tip 2 ORF2 proteina: minimu RP * 1. 0 massimu RP * 3. 75 * potenza relattiva (test ELISA) permezz ta ’ paragun ma ’ tilqima ta ’ referenza
Adjuvant:
Sustanti mhux attivi:
Pigs (from 2 weeks of age)
Qżieqeż (mill- età ta ’ ġimagħtejn)
4.2 Indications for use, specifying the target species
4. 2 Indikazzjonijiet għall- użu tal- prodott li jispeċifikaw l- ispeċi li fuqhom se jintuża l- prodott.
For active immunisation of pigs over the age of 2 weeks against Porcine Circovirus Type 2 (PCV2) to reduce mortality, clinical signs - including weight loss - and lesions in lymphoid tissues associated with PCV2 related disease (PCVD).
Għal tilqima ilqima attiva ta ’ qżieqeż fuq l- età ta ’ ġimagħtejn kontra Circovirus tal- Qżieqeż ta ’ Tip 2 (PCV2) biex titnaqqas il- mortalità, sinjali kliniċi - li jinkludu telf ta ’ piż – u leżjonijiet f’ tessuti limfojde assoċjati ma ’ mard marbut ma ’ PCV2 (PCVD).
In addition, vaccination has been shown to reduce PCV2 nasal shedding, viral load in blood and lymphoid tissues, and duration of viraemia.
Flimkien ma ’ dan, intwera li t- tilqima tnaqqas it- tneħħija ta ’ twaqqigħ nażali PCV2, it- tagħbija virali fid- demm u fit- tessuti limfodje, u t- tul ta ’ żmien kemm iddum il- viraemia.
Onset of protection occurs as early as 2 weeks post vaccination and lasts for at least 17 weeks.
Il- protezzjoni tibda sseħħ minn kmieni sa minn ġimagħtejn wara t- tilqima u ddum għal mill- inqas 17- il ġimgħa.
Only healthy animals should be vaccinated.
Annimali b’ saħħithom biss għandhom ikunu mlaqqma.
A mild and transient hyperthermia very commonly occurs on the day of vaccination.
Ipertermija ħafifa u temporanja jseħħu b’ mod komuni ħafna fil- jum tat- tilqima.
Do not use during pregnancy and lactation.
Tużahx fit- tqala u fi żmien il- ħalib.
No information is available on the compatibility of this vaccine with any other.
L- ebda informazzjoni dwar il- kompatibilità ta ’ din it- tilqima ma ’ xi tilqima oħra mhi disponibbli.
Therefore the safety and efficacy of this product when used with any other (either when used on the same day or at different times) has not been demonstrated.
Għalhekk is- sigurtà u l- effikaċja ta ’ dan il- prodott meta jintuża ma ’ kwalunkwe tilqima oħra (sew meta jintuża fl- istess jum jew fi żmien differenti) ma ntwerietx.
Single intramuscular injection of one dose (1 ml), irrespective of body weight.
Injezzjoni waħda ġol- muskoli ta ’ doża waħda (1 ml), irrispettivament mill- piż tal- ġisem.
Use vaccination devices according to the manufacturer's instruction.
Użu t- tagħmir tat- tilqim skond l- istruzzjonijiet tal- manifattur.
Avoid multiple broaching.
Evita titqib multiplu.
Following the administration of a 4-fold overdose of vaccine no adverse reactions other than those described under section 4.6. have been observed.
Wara l- għoti ta ’ doża eċċessiva ta ’ 4 darbiet aktar tat- tilqima, l- ebda reazzjonijiet avversi minbarra dawk deskritti taħt sezzjoni 4. 6. ma kienu osservati.
4.11 Withdrawal period
4. 11 Perjodu ta ’ tiżmim
Inactivated Porcine circovirus vaccine
Tilqima diżattivata ta ’ circovirus tal- qżieqeż
ATC vet code:
Kodici ATĊ veterinarja:
This vaccine is designed to stimulate the development of an active immune response to Porcine circovirus type 2.
Din it- tilqima hi maħsuba biex tistimula l- iżvilupp ta ’ rispons immuni attiv għal circovirus tal- qżieqeż ta ’ tip 2.
Sodium chloride Water for injection
Sodium chloride Ilma għall- injezzjonijiet
3 6.2 Incompatibilities
6. 3 Żmien ta ’ kemm il- prodott idum tajjeb
Do not mix with any other vaccine or immunological product.
Żmien li l- prodott mediċinali veterinarju jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ:
6.3 Shelf life
15- il xahar.
Use immediately after opening.
Uża immedjatament wara li tiftħu.
Store and transport refrigerated (2 °C – 8 °C).
Aħżen u ttrasporta ġo friġġ (2 C – 8 C).
High density polyethylene bottles of 10 ml, 50 ml, 100 ml or 250 ml with a chlorobutyl stopper and lacquered aluminium seal.
Fliexken ta ’ densità qawwija tal- polyethylene ta ’ 10 ml, 50 ml, 100 ml jew 250 ml b’ tapp tal- chlorobutyl u siġill aluminju lacquered.
Each bottle is packed individually in a cardboard box.
Kull flixkun hu ppakkjat individwalment fil- kaxxa tal- kartun.
Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/ Rhein Germany
Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/ Rhein Il- Ġermanja
The import, sale supply and/ or use of Ingelvac CircoFLEX is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
L- importazzjoni, bejgħ, provvista u/ jew l- użu ta 'Ingelvac CircoFLEX huwa pprojbit jew jista ’ jkun ipprojbit f' ċerti Stati Membri jew ġo parti mit- Territorju tagħhom minħabba l- politika nazzjonali tagħhom dwar is- saħħa ta ’ l- annimali.
Any person intending to import, sell, supply and/ or use Ingelvac CircoFLEX must consult the relevant Member State's competent authority on the current vaccination policies prior to the import, sale, supply and/ or use.
Kull persuna li turi l- intenzjoni li timporta, tbiegħ, tipprovdi u/ jew tuża Ingelvac CircoFLEX għandha tikkonsulta ma ’ l- Awtorità Kompetenti ta ’ l- Istat Membru dwar il- programmi ta 'tilqim kurrenti qabel timporta, tbiegħ, tipprovdi u/ jew tuża.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinsab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA (/ BIJOLOĠIĊI) ATTIVA( I) U S- SID/ SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL- PROVVISTA 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
Name and address of the manufacturer(s) of the biological active substance(s) Boehringer Ingelheim Vetmedica Inc.
Isem u indirizz tal- manifattur( i) tas- sustanza( i) bijoloġika( ċi) attiva( i) Boehringer Ingelheim Vetmedica Inc.
Joseph, Missouri, 64506 U. S. A.
Joseph, Missouri, 64506 L- ISTATI UNITI TA ’ L- AMERIKA
Name and address of the manufacturer(s) responsible for batch release Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/ Rhein GERMANY
Isem u indirizz tal- manifattur( i) responsabbli mill- ħruġ tal- lott Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/ Rhein IL- ĠERMANJA
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Id- detentur ta ’ din l- awtorizzazzjoni għat- tqegħid fis- suq għandu jinforma lill- Kummissjoni Ewropea dwar il- pjanijiet kummerċjali għall- prodott mediċinali awtorizzat minn din id- deċiżjoni.
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
a) l- għotja tal- prodott mediċinali veterinarju lill- annimali tinterferixxi ma ’ l- implimentazzjoni ta ’ programmi nazzjonali għad- dijanjosi, il- kontroll u l- eradikazzjoni tal- mard ta ’ l- annimali, jew tikkawża diffikultajiet fiċ- ċertifikazzjoni ta ’ l- assenza tal- kontaminazzjoni f’ annimali ħajjin jew fl- ikel jew prodotti oħrajn akkwistati minn annimali ttrattati;
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
b) il- marda li għaliha l- prodott mediċinali veterinarju huwa intiż li jagħti immunità hija ġeneralment assenti mit- territorju..
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV
Sodium chloride is included in Annex II of Council Regulation (EEC) No 2377/ 90 in accordance with the following table:
2377/ 90 skond it - tabella li ġejja:
All food-producing species
Carbomer hu kkunsidrat li mhuwiex
Carbomer is considered not within the scope of Council Regulation (EEC) No.
fl- ambitu tar- Regolament tal- Kunsill (KEE) Nru.
LABELLING AND PACKAGE LEAFLET
TIKKETTA U L- FULJETT TA ’ TAGĦRIF FIL- PAKKETT
9 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
9 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
{10 ml; 50 ml, 100 ml, 250 ml cardboard box}
{10 ml, 50 ml, 100 ml, 250 ml kaxxa tal- kartun}
Each dose of inactivated vaccine contains:
Kull doża ta ’ tilqima diżattivata fiha:
Porcine circovirus type 2 ORF2 protein Carbomer
Circovirus tal- qżieqeż ta ’ tip 2 ORF2 proteina Carbomer
10 ml (10 doses) 50 ml (50 doses) 100 ml (100 doses) 250 ml (250 doses)
10 ml (10 dożi) 50 ml (50 doża) 100 ml (100 doża) 250 ml (250 doża)