qanastek/EMEA-V3 huggingface dataset:
Infusion bag 60 ml per bag (polyolefin)
60 ml / Borża ta ’ Borża ta ’ infużjoni:
Oxyglobin 130 mg/ ml solution for infusion for dogs.
Oxyglobin 130 mg/ ml soluzzjoni għal infużjoni għall- klieb
Haemoglobin glutamer-200 (bovine) – 130 mg/ ml
Haemoglobin glutamer- 200 (bovina) – 130 mg/ ml
Oxyglobin provides oxygen carrying support to dogs improving the clinical signs of anaemia for at least 24 hours, independent of the underlying condition.
Oxyglobin jipprovdi għajnuna ta ’ ġarr ta ’ ossiġenu fil- klieb u għaldaqstant itejjeb is- sinjali kliniċi ta ’ anemija għal mill- anqas 24 siegħa indipendentement minn mard ieħor.
Do not use in animals previously treated with Oxyglobin.
Tużax fi annimali li diġa ġew ittrattati qabel b 'Oxyglobin.
Plasma volume expanders, such as Oxyglobin, are contraindicated in dogs predisposed to circulatory overload with conditions such as oliguria or anuria or advanced cardiac disease (i. e., congestive heart failure) or otherwise severely impaired cardiac function.
Sustanzi li jkabbru l- volum tal- plasma, bħalma huwa Oxyglobin huma kontra- indikati fi klieb predisposti għal tħaddim ċirkolatorju żejjed b’ kundizzjonijiet bħalma huma oligurja jew anurja jew mard avvanzat tal- qalb (i. e., falliment tal- qalb minħabba konġestjoni) jew tħaddim tal- qalb severament indebolit.
Oxyglobin is intended for single administration only.
Oxyglobin huwa ntenzjonat li jingħata darba biss.
Special precautions for use in animals
2 4. 5 Prekawzjonijiet Speċjali għall- Użu
Concomitant treatment of the cause of the anaemia should be instituted.
Prekawzjonijiet speċjali għall- użu fl- annimali Flimkien ma Oxyglobin, wieħed għandu jibda trattament, għal anemija.
The animal should not be over-hydrated prior to administration.
L- annimal ma għandux ikun idrat iżżejjed qabel l- amministrazzjoni.
Due to the plasma expanding properties of Oxyglobin, the possibility of circulatory overload and pulmonary oedaema should be considered especially when administering adjunctive intravenous fluids, particularly colloidal solutions.
Minħabba l- karatteristiċi ta ’ l - espansjoni tal- plasma ta ’ Oxyglobin, għandha titqies il- possibilità ta ’ tagħbija ċirkolatorja żejda u edema pulmonari speċjalment meta jiġu mogħtija fluwidi ġol- vini, b’ mod partikolari soluzzjonijiet ta ’ għamla kollojdjali.
Signs of circulatory overload should be carefully monitored or central venous pressure (CVP) measured (increase in CVP has been recorded in all treated dogs in which it was measured).
Sinjali ta ’ tagħbija ċirkolatorja żejda għandhom jiġu mgħassa b’ attenzjoni jew għandha tiġi mkejla l- pressjoni venuża ċentrali (CVP) (ġiet irreġistrata żjieda fil- CVP fil- klieb kollha trattati kull meta ġiet imkejjla).
Circulatory overload may be controlled by slowing the rate of administration.
It- tagħbija ċirkolatorja żejda tista ’ tiġi kkontrollata billi tiġi mnaqqsa r- rata t ’ amministrazzjoni.
2 Treatment with Oxyglobin results in a mild decrease in PCV (packed cell volume) immediately post infusion.
It- trattament bOxyglobin jirriżulta fi tnaqqis ħafif fil- PCV (volum ippakkjat taċ- ċelloli) immedjatament wara l- infużjoni.
The safety and efficacy of Oxyglobin have not been evaluated in dogs with thrombocytopenia with active bleeding, oliguria or anuria, or advanced cardiac disease.
Il- ħarsien tas- saħħa u l- effikaċja ta ’ Oxyglobin ma ġewx evalwati fuq il- klieb bi, trombositopenja akkumpanjata minn telf ta ’ demm, oligurja jew anurja, jew mard tal- qalb avvanzat.
Clinical Pathology
Patoloġija Klinika
The presence of Oxyglobin in serum may interfere with colorometric readings and result in artifactual increases or decreases in the results of serum chemistry tests depending on the dosage administered, the time since infusion, the type of analyzer and the reagents used.
Dan jiddependi fuq id- dożaġġ mogħti, il- ħin mill- infużjoni, t- tip ta ’ analizzatur u l- kimiċi wżati fl- analiżi.
(Contact the distributor for specific data.)
(Ikkuntattja d - distributur għal tagħrif speċifiku.)
No interference.
L- ebda interferenza.
Confirm that haemoglobin is measured, not calculated from red blood cell number.
Agħmel ċert li l- emoglobina tiġi mkejjla u mhux ikkalkulata min - numru ta ’ ċelloli tad- demm ħomor.
Coagulation:
Koagulazzjoni:
Prothrombin time (PT) and activated partial thromboplastin time (aPTT) can be accurately determined using methods that are mechanical, magnetic, and light scattering.
Prothrombin time (PT) u activated partial thromboplastin time (aPTT) jistgħu jiġu determinati b’ mod preċiż billi jiġu wżati metodi li huma mekkaniċi, manjetiċi u li jifirxu d- dawl.
Optical methods are not reliable for coagulation assays in the presence of Oxyglobin.
Metodi optiċi m’ humiex affidabbli għal assaġġi ta ’ koagulazzjoni fil- preżenza ta ’ Oxyglobin.
Urinalysis:
Urinaliżi:
Sediment examination is accurate.
Eżaminazzjoni tas- sediment hija preċiża.
Dipstick measurements (i. e., pH, glucose, ketones, protein) are inaccurate while gross discolouration of the urine is present.
Kejl bl- istikka (i. e., pH, glukosju, ketoni, proteina) mhuwiex preċiż, filwaqt li hemm tibdil fil- kulur totali ta ’ l- awrina.
Adverse events related to Oxyglobin and/ or the underlying disease causing anaemia have been observed.
Ġew osservati avvenimenti li għandhom x’ jaqsmu ma ’ Oxyglobin u/ jew ma ’ mard ieħor li jikkawża anemija.
Undesirable effects include mild to moderate yellow/ orange discoloration of the skin, mucous membranes, sclera, dark faeces and discoloured or turbid urine due to metabolism and/ or excretion of haemoglobin.
Effetti mhux mixtieqa jinkludu tifi ħafif għal moderat safrani/ oranġju fil- kulur tal- ġilda, fil - membrani mukużi, sklera, ħmieġ skur u awrina mdardra minħabba l- metaboliżmu u/ jew il- ħruġ ta ’ l - emoglobina.
A commonly observed undesirable effect was circulatory overload with associated clinical signs such as tachypnea, dyspnea, harsh lung sounds and pulmonary edaema.
Effett mhux mixtieq osservat b’ mod komuni kien it- tagħbija ċirkolatorja żejda b’ sinjali kliniċi assoċjati bħalma huma nifs frekwenti, qtugħ ta ’ nifs, ħsejjes ħorox mill- pulmun, u edema pulmonari.
Adverse effects commonly seen were vomiting, a loss of appetite, and fever.
Effetti oħra mhux mixtieqa li dehru frekwentement kienu remmettar, nuqqas fl- aptit u deni.
Occasionally noted adverse events were diarrhoea, cardiac arrhythmias and very rarely nystagmus.
Kultant ġew innotati każijiet ta ’ dijarea, arrittmiji kardijaċi, u rari ħafna nistagmus.
The safety of Oxyglobin for use in pregnant or lactating bitches has not been determined.
Il- ħarsien tas- saħħa ta ’ Oxyglobin għal użu fi klieb nisa tqal jew li jagħtu l- ħalib għadu ma ġiex stabbilit.
4.8 Interaction with other medicinal products and other forms of interaction
3 4. 8 Effetti fuq prodotti mediċinali oħra jew effetti oħra
The recommended dosage of Oxyglobin is 30 ml/ kg of body weight administered intravenously at a rate up to 10 ml/ kg/ hr.
Id- dożaġġ rakkommandat ta ’ Oxyglobin huwa ta ’ 30 ml/ kg tal- piż tal- annimal meta mogħti ġol- vina b’ rata sa 10 ml/ kg fis- siegħa.
Oxyglobin is intended for single administration.
Oxyglobin huwa maħsub sabiex jiġi amministrat darba biss.
In certain clinical situations, a dosage of 15-30 ml/ kg may be appropriate.
F’ ċerti sitwazzjonijiet kliniċi, dożaġġ ta ’ 15- 30 ml/ kg jista ’ jkun adattat.
The optimum dosage is based upon the degree and chronicity of the anaemia and the desired duration of the effect.
L- aħjar dożaġġ huwa bbażat fuq il- grad u l- kroniċità ta ’ l- anemija u t- tul mixtieq ta ’ l- effett tat- trattament.
(See Table A Pharmacokinetic Parameters)
Parametri Farmakokinetiċi)
Pharmacokinetic Parameters at Multiple Dose Levels after a Single Infusion of Oxyglobin
Parametri Farmakokinetiċi ta ’ Dożi Multipli wara Infużjoni Waħdanija ta ’ Oxyglobin
Duration (hours):
Konċentrazzjoni Tul ta ’ ħin (sigħat):
Cleared from
Imneħħi mill -
infusion plasma
ta ’ plasma
Oxyglobin levels over
Livelli ta ’
concentration* (g/ dl)
immedjatament wara l - infużjoni * (g/ dl)
1 g/ dl
oxyglobin ‘ l fuq minn 1 g/ dl
(days)***
(jiem) ***
range based on mean ± SD range based on estimated mean value with bounds of a 95% prediction interval range based on 5 terminal half-lives
* medda bbażata fuq medja ± SD ** medda bbażata fuq stima ta ’ valur medju b’ limiti ta ’ intervall ta ’ tbassir ta ’ 95% *** medda bbażata fuq 5 half- lives terminali
Remove overwrap prior to use.
Neħħi t- tgeżwir qabel l- użu.
Use within 24 hours.
Uża fi żmien 24 siegħa.
Oxyglobin should be administered using aseptic technique via a standard intravenous infusion set and catheter.
Oxyglobin għandu jiġi mogħti billi tintuża teknika aseptika permezz ta ’ sett ta ’ infużjoni standard fil- vina u katiter.
As with any intravenous fluid administration, Oxyglobin should be warmed to 37° C prior to administration.
Bħal f’ kull għoti ta ’ fluwidu fil- vina, Oxyglobin għandu jissaħħan sa 37°Ċ qabel l- għoti.
Do not microwave.
Tpoġġihx fil - microwave.
Do not overheat.
Issaħħnux iżżejjed.
Use of Oxyglobin does not require typing or cross – matching of the recipient ’ s blood.
L- użu ta ’ Oxyglobin ma jeħtieġx eżaminazzjoni għat- tip tad- demm jew għal tqabbil ma ’ tar- riċevitur.
Overdosage or an excessive rate of administration (i. e., > 10 ml/ kg/ hr) could result in immediate cardiopulmonary effects, in which case infusion of Oxyglobin should be discontinued immediately until signs abate.
Doża eċċessiva jew rata eċċessiva ta ’ għoti (i. e., > 10 ml/ kg/ siegħa) jista ’ jkollha effetti kardjopulmonarji immedjati, f’ liema każ l- infużjoni ta ’ Oxyglobin għandha titwaqqaf immedjatament sakemm ibattu s- sinjali.
Treatment of circulatory overload may be necessary.
Jista ’ jkun hemm bżonn ta ’ trattament għat- tagħbija ċirkolatorja żejda.
Blood substitutes, ATCvet code:
Sostituti tad- demm, Kodici ATĊ veterinarja:
5.1 Pharmacodynamic properties
4 5. 1 Kwalitajiet Farmakodinamiċi
Oxyglobin is a haemoglobin-based oxygen carrying fluid that increases plasma and total haemoglobin concentrations and thus increases arterial oxygen content.
Oxyglobin huwa fluwidu li jġorr l- ossiġenu ibbażat fuq l- emoglobina li jżid il- konċentrazzjoni fil - plasma u l- konċentrazzjonijiet totali ta ’ l- emoglobina u b’ hekk iżid il- kontenut ta ’ l- ossiġenu fl- arterji.
The plasma half-life is 30- 40 hours.
Il- ħin kemm il- plasma tieħu biex tinżel bin- nofs huwa ta ’ 30- 40 siegħa.
It is eliminated from the plasma in 5-7 days.
Huwa eliminat mill- plasma f’ 5- 7 t’ ijiem.
Metabolism and excretion:
Il- metaboliżmu u l- eliminazzjoni mill- ġisem:
Haemoglobin dissociates in plasma and is progressively incorporated in the protein pool of the organism.
L- emoglobina tinfired fil- plasma u hija progressivament inkorporata fit- taħlita ta ’ proteini ta ’ l- organiżmu.
Haeme degrades according to common pathways leading to bilirubin and bile pigments.
L- haeme tiddegrada skond rotot komuni li jwasslu għal bilirubin u pigmenti tal- bili.
A small amount of unstabilised tetrameric haemoglobin (< 5%) may be excreted through the kidneys, resulting in transient haemoglobinuria for < 4 hours.
Jista ’ jiġi eliminat mill- ġisem, ammont żgħir ta ’ emoglobina tetramerika mhux stabbilizzata (< 5%), li jirriżulta f’ emoglobinurja li tgħaddi f' inqas minn4 sigħat.
Water for injection, NaCl KCl CaC12 2H2O NaOH Sodium lactate N-acetyl-l cysteine
Modified Lactated Ringer’ s Solution li fiha l- komponenti standard: ilma għal injezzjoni, NaCl, KCl, CaC12 2H2O, NaOH, sodium lactate, N- acetyl- l cysteine.
Do not administer with other fluids or medicinal products concurrently via the same infusion set.
Tagħtix flimkien ma ’ fluwidi jew prodotti mediċinali oħra fl- istess ħin permezz ta ’ l- istess sett ta ’ infużjoni.
Do not add medications or other solutions to the bag.
Iżżidx medikazzjonijiet jew soluzzjonijiet oħra fil- borża.
Do not combine the contents of more than one bag.
Tħallatx flimkien il- kontenut ta ’ aktar minn borża waħda.
3 years Shelf-life after first opening the immediate packaging:
Żmien li l- prodott mediċinali veterinarju jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ: 3 snin Żmien li l- prodott jibqa ’ tajjeb wara li jkun tneħħa mill- ewwel ippakkjar:
Do not store above 30°C.
Taħżinx f' temperaturi ogħla minn 30°C.
Do not freeze.
Tagħmlux tiffriżax.
Use within 24 hours of removing overwrap.
Uża fi żmien 24 siegħa minn meta tneħħi t - tgeżwir ta ’ barra
A box with two (2) polyolefin infusion bags (60 ml), each within an overwrap.
Kaxxa b’ żewġ boroż ta ’ infużjoni polyolefin (60 mL), kull waħda fi mgewżra f’ inforra.
A box with two (2) polyolefin infusion bags (125 ml), each within an overwrap.
Kaxxa b’ żewġ boroż ta ’ infużjoni polyolefin (125 mL), kull waħda fi mgewżra f’ inforra.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURA TAS- SUSTANZA BIOLOĠIKA ATTIVA U SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL - LOTT
Name and address of the manufacturer of the biological active substance Biopure Corporation 39 Hurley Street Cambridge MA 02141 USA
Parnassustoren / Locatellikade 1 NL - 1076 AZ Amsterdam
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Fuq il- fuljett ta 'tagħrif tal- prodott mediċinali għandu jkun hemm l- isem u l- indirizz tal- manifattur responsabbli mill- ħruġ tal- lott konċernat >
Oxyglobin 130 mg/ ml Solution for infusion for dogs.
Oxyglobin 130 mg/ ml soluzzjoni għal infużjoni għall- klieb
Hemoglobin glutamer-200 (bovine) – 130 mg/ ml
Haemoglobin glutamer- 200 (bovina) – 130 mg/ ml
Solution for infusion
Soluzzjoni għal infużjoni.
Two single dose bags (60 ml) for intravenous infusion each within an overwrap< outer box > Overwrap containing a 60 ml infusion bag < overwrap> 60 ml infusion bag < infusion bag >
Borża ta ’ infużjoni ta ’ 60 ml.
Two single dose bags (125 ml) for intravenous infusion each within an overwrap< outer box > Overwrap containing a 125 ml infusion bag < overwrap> 125 ml infusion bag < infusion bag >
Borża ta ’ infużjoni ta ’ 125 ml.
Oxyglobin is intended for single intravenous administration by infusion.
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett
Do not microwave.
Tagħmlux fil- microwave.
Do not overheat > 37° C.
Issaħħanx iżżejjed > 37° C.
< EXP {month/year} >
< Jiskadi {xahar / sena} >
13 PACKAGE LEAFLET
FULJETT TA 'TAGĦRIF FIL- PAKKETT
Oxyglobin 130 mg/ ml Solution for infusion for dogs
13 FULJETT TA ’ TAGĦRIF FIL- PAKKETT Oxyglobin 130 mg/ ml soluzzjoni għal infużjoni għal klieb
Oxyglobin 130 mg/ ml Solution for infusion for dogs
Oxyglobin 130 mg/ ml soluzzjoni għal infużjoni għal klieb.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
3 DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA( I) U INGREDJENT( I) OĦRA
Oxyglobin provides oxygen carrying support to dogs improving the clinical signs of anaemia for at least 24 hours independent of the underlying condition.
Oxyglobin jipprovdi għajnuna ta ’ ġarr ta ’ ossiġenu fil- klieb u għaldaqstant itejjeb is- sinjali kliniċi ta ’ anemija għal mill- anqas 24 siegħa indipendentement minn mard ieħor.
During the clinical safety and efficacy study, adverse events were seen which may have been related to Oxyglobin and/ or the underlying disease causing anaemia.
Matul l- istudju dwar il- ħarsien tas- saħħa u l- effikaċja klinika, dehru effetti mhux mixtieqa li jista ’ jkollhom x’ jaqsmu ma ’ Oxyglobin u/ jew il- marda li qed tikkawża l- anemija.
Side effects which were observed included mild to moderate discolouration of the mucous membranes, sclera, and urine due to metabolism and/ or excretion of haemoglobin.
Effetti oħra li ġew osservati jinkludu t- tifi tal- kulur tal- membrani mukużi, sklera, u l- awrina minħabba l- metaboliżmu u/ jew il- ħruġ ta ’ l- emoglobina.
Effects commonly seen were vomiting, loss of appetite, fever, and circulatory overload with associated clinical signs such as tachypnea, dyspnea, harsh lung sounds, and pulmonary edaema; circulatory overload was controlled by slowing the rate of administration.
Effetti komuni li dehru kienu remmettar, nuqqas ta ’ aptit, deni, tagħbija ċirkolatorja żejda b’ sinjali kliniċi assoċjati bħal rata ta ’ nifs mgħaġġel, qtugħ ta ’ nifs, ħsejjes ħorox mill- pulmun, u edema pulmonarja; it- tagħbija ċirkolatorja żejda ġiet ikkontrollata billi ġiet imnaqqsa r - rata ta ’ infużjoni.
Occasionally noted effects were diarrhoea, discolouration of the skin, cardiac arrhythmias and very rarely nystagmus.
B’ mod okkażjonali ġew innutati effetti bħalma huma d- dijarea, tifi fil- kulur tal - ġilda, arrittmiji kardijaċi u rari ħafna nistagmus.
The recommended dosage of Oxyglobin is 30 ml/ kg of body weight administered intravenously at a rate up to 10 ml/ kg/ hr.
Id- dożaġġ rakkommandat ta ’ Oxyglobin huwa ta ’ 30 ml/ kg tal- piż tal- annimal amministrat fil- vina b’ rata sa 10 ml/ kg fis- siegħa.
The optimum dosage is based upon the degree and chronicity of the anemia and the desired duration of the effect.
L- aħjar dożaġġ huwa bbażat fuq il- grad u l- kroniċità ta ’ l- anemija u t- tul mixtieq ta ’ l- effett.
(See Table A Pharmacokinetic Parameters)
(Ara t - Tabella A Parametri Farmakokinetiċi)
Pharmacokinetic Parameters at Multiple Dose Levels after a Single Infusion of Oxyglobin
Parametri Farmakokinetiċi fil- Livelli ta ’ Dożi Multipli Wara Infużjoni Waħdanija ta ’ Oxyglobin
Immediate post
Konċentrazzjo
Duration hours):
Tul ta ’ ħin (sigħat):
infusion plasma Oxyglobin levels over
ni fil- plasma
1 g/ dL
oxyglobin ‘ l fuq minn 1 g/ dL
** range based on estimated mean value with bounds of a 95% prediction interval *** range based on 5 terminal half-lives
* medda bbażata fuq medja ± SD ** medda bbażata fuq stima ta ’ valur medju b’ limiti ta ’ interval ta ’ tbassir ta ’ 95% *** medda bbażata fuq 5 half- lives terminali
Oxyglobin should be administered using aseptic technique via a standard intravenous infusion set and catheter.
Oxyglobin għandu jiġi mogħti billi tintuża teknika aseptika permezz ta ’ sett ta ’ infużjoni standard fil- vina, u katiter.
Do not administer with other fluids or medicinal products concurrently via the same infusion set.
Tagħtihx flimkien ma ’ fluwidi jew prodotti mediċinali oħra fl- istess ħin permezz ta ’ l- istess sett ta ’ infużjoni.
Do not use after the expiry date stated on the label.
Uża fi żmien 24 siegħa minn meta tneħħi t - tgeżwir ta ’ barra Tużax wara d- data tal- iskadenza fuq it- tikketta.
Do not use in animals previously treated with Oxyglobin.
Tużahx fuq annimali li kienu ġew ittrattati darb’ oħra b ’ Oxyglobin.
Concomitant treatment of the cause of the anaemia should be instituted.
Flimkien ma Oxyglobin, wieħed għandu jibda trattament, għal anemija.
Due to the plasma expanding properties of Oxyglobin, the possibility of circulatory overload should be considered especially when administering adjunctive intravenous fluids, particularly colloidal solutions. circulatory overload should be carefully monitored or central venous pressure (CVP) CVP increases
Minħabba l- karatteristiċi ta ’ l - espansjoni tal- plasma ta ’ Oxyglobin, għandha titqies il- possibilità ta ’ tagħbija ċirkolatorja żejda u edema pulmonari speċjalment meta jiġu mogħtija fluwidi ġol- vini, b’ mod partikolari soluzzjonijiet ta ’ għamla kollojdjali.
to a clinically unacceptable level and/ or if signs of circulatory overload are observed, the infusion of Oxyglobin should be temporarily discontinued and re-instituted at a slower rate when signs abate and/ or CVP decreases.
Jekk il- CVP tiżdied għal livell klinikament mhux aċċettabbli u/ jew jekk jiġu osservati sinjali ta ’ tagħbija ċirkolatorja żejda, l- infużjoni ta ’ Oxyglobin għandha tiġi mwaqqfa temporanjament u terġa tinbeda bil- mod b’ rata aktar baxxa meta s- sinjali jbattu
Treatment with Oxyglobin results in a mild decrease in PCV (packed cell volume) immediately post infusion.
It- trattament bOxyglobin jirriżulta fi tnaqqis ħafif fil- PCV (volum ippakkjat taċ- ċelloli) immedjatament wara l- infużjoni.
The safety and efficacy of Oxyglobin have not been evaluated in dogs with, thrombocytopenia with active bleeding, oliguria or anuria, or advanced cardiac disease.
Il- ħarsien tas- saħħa u l- effikaċja ta ’ Oxyglobin ma ġewx evalwati fuq il- klieb bi, trombositopenja akkumpanjata minn telf ta ’ demm, oligurja jew anurja, jew mard tal- qalb avvanzat.
The use in such animals is not recommended.
L- użu fuq annimali bħal dawn mhuwiex rakkommandat.
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 /.
Clinical Pathology
Pataloġija klinikali
The presence of Oxyglobin in serum may interfere with colorometric readings and result in artifactual increases or decreases in the results of serum chemistry tests depending on the dosage administered, the time since infusion, the type of analyzer and the reagents used.
Il- preżenza ta ’ Oxyglobin fis- serum tista ’ tinterferixxi mal- qari kolorometriku u tista ’ tirriżulta f’ żjidiet jew tnaqqis artifattwali fir- riżultati tat- testijiet kimiċi tas- serum jiddependi fuq id - dożaġġ mogħti, il- ħin sa mill- infużjoni, it- tip ta ’ analizzatur u l- kimiċi wżati fl- analiżi.
(Contact the distributor for specific data.)
(Ikkuntattja d - distributur għal tagħrif speċifiku).
Confirm that haemoglobin is measured, not calculated from red blood cell number.
Agħmel ċert li l- emoglobina tiġi mkejjla u mhux ikkalkolata min - numru ta ’ ċelloli tad- demm ħomor.
60 ml infusion bag.
Borża ta ’ infużjoni ta ’ 60 ml.
125 ml infusion bag.
Borża ta ’ infużjoni ta ’ 125 ml.
MA Numbers
Numru ta ’ l- UE
Packaging
Ippakkjar Kontenut
Intramammary Solution
Soluzzjoni
Intramammary Use
Għal użu
Pre-filled syringe (PE)
Siringi
8 pre-filled syringes (in a cardboard box)
8 siringi
Meat and offal:
interjuri:
24 pre-filled syringes (in a cardboard box)
24 siringa
120 pre-filled syringes (in a plastic bucket)
120 siringa
PIRSUE 5 mg/ ml intramammary solution for cattle
PIRSUE 5 mg/ ml soluzzjoni intramammarja għal baqar.
Active substance(s):
Sustanza Attiva:
Pirlimycin hydrochloride equivalent to 50 mg pirlimycin per 10 ml syringe
Pirlimycin hydrochloride ekwivalenti għal 50 mg pirlimycin f’ kull siringa ta ’ 10 ml.
For a full list of excipients see Section 6.1
Għal- lista sħiħa ta ’ l- ingredjenti (mhux attivi), ara s- sezzjoni 6. 1.
Intramammary solution
Soluzzjoni intramammarja.
Cattle (lactating dairy cows)
Baqar (baqar tal- ħalib li qed jaħilbu).
For the treatment of subclinical mastitis in lactating cows due to Gram-positive cocci susceptible to pirlimycin including staphylococcal organisms such as Staphylococcus aureus, both penicillinase-positive and penicillinase-negative, and coagulase-negative staphylococci; streptococcal organisms including Streptococcus agalactiae, Streptococcus dysgalactiae and Streptococcus uberis.
Għal kura ta ’ mastite mingħajr sintomi, f’ baqar li qed jaħilbu, ikkawżata minn kokki Gram- positive li jirrispondu għall- pirlimycin, u dawn jinkludu mikrobi stafilokoċċi bħal Staphylococcus aureus, kemm l- istafilokoċċi penicillinase- positive kif ukoll penicillinase- negative u coagulase- negative; mikrobi streptokoċċi li jinkludu Streptococcus agalactiae, Streptococcus dysgalactie u Streptococcus uberis.
Resistance against pirlimycin.
Reżistenza għall- pirlimycin.
Treatment of infections due to Gram-negative bacteria such as E. coli.
Kura għal infezzjonijiet ikkawżati minn mikrobi Gram- negative bħal E. coli.
Do not treat cows with palpable udder changes due to chronic subclinical mastitis.
Tikkurax baqar li f’ driegħhom jinħass tibdil ikkawżat minn mastite kronika mingħajr sintomi.
None.
M’ hemmx.
4.5 Special precautions for use
4. 5 Prekawzjonijiet speċjali għall- Użu
Susceptibility testing of the target bacteria should be carried out prior to treatment.
Qabel tinbeda l- kura għandhom isiru testijiet tas- suxxettibilità fuq il- mikrobi iżolati.
Avoid contact with the solution.
Evita li tmiss it- taħlita.
Wash hands and any exposed skin with soap and water and remove contaminated clothing immediately after use.
Aħsel idejk u xi partijiet tal- ġilda li jistgħu jintlaqtu, b’ sapun u ilma u neħħi ħwejjeġ ikkontaminati mill- ewwel wara l- użu.
Flush eyes with water for 15 minutes immediately after exposure.
Jekk jintlaqtu l- għajnejn laħlaħ sew fil- pront bl- ilma għal ħmistax- il minuta.
Hold eyelids open to ensure complete contact with water.
Żomm l- għajnejn miftuħin biex ikun hemm kuntatt sħiħ ma ’ l- ilma.
6 Adverse reactions (frequency and seriousness)
2 4. 6 Effetti mhux mixtieqa (frekwenza u gravità)
The product is indicated for use in lactating dairy cows and can be used during pregnancy.
Il- prodott huwa indikat għall- użu f’ baqar li qed jinħalbu u jista ’ jintuża waqt it- tqala.
Cross-resistance may occur between pirlimycin and other lincosamides or macrolides.
Jista ’ jkun hemm reżistenza inkroċjata bejn il- pirlimycin u lincosamides oħra jew macrolides.
Administration: by intramammary infusion only.
Amministrazzjoni: permezz ta ’ infużjoni intramammarja biss.
Infuse one syringe (50 mg pirlimycin) into each infected quarter.
Agħti infużjoni ta ’ siringa waħda (50 mg pirlimycin) f’ kull beżżula infettata.
Treatment consists of eight infusions of one syringe every 24 hours.
Il- kura tikkonsisti fi tmien infużjonijiet ta ’ siringa waħda kull erbgħa u għoxrin siegħa.
Care must be taken not to introduce pathogens into the teat in order to reduce the risk of E. coli infections.
Għandha tingħata attenzjoni biex ma jiddaħħlux mikrobi fil- beżżula biex jitnaqqas ir- riskju ta ’ infezzjonijiet bi E. coli.
Ensure adequate cleansing of the teat (and udder - if needed) before infusion.
Kun żgur li l- beżżula tkun imnaddfa sew (u d- driegħ kollu – jekk ikun hemm bżonn) qabel issir l- infużjoni.
The following instructions should therefore be followed carefully.
It- tagħrif li ġej għandu għalhekk jiġi segwit sew.
Clean hands before handling the cow's udder.
Aħsel idejk sew qabel tmiss id- driegħ tal- baqra.
Wash the udder if it is dirty.
Aħsel id- driegħ jekk ikun maħmuġ.
Where necessary, wash teats thoroughly with warm water containing a suitable dairy cleansing agent and dry them thoroughly.
Fejn ikun hemm bżonn aħsel il- bżieżel sew b- ilma fietel li jkun fih sustanza apposta għal ħasil u ixxutthom sew.
Disinfect teat end using a suitable cleansing agent.
Iddiżinfetta t- tarf tal- beżżula b’ sustanza apposta għal ħasil.
The teat end should be cleaned until no more dirt appears on the swab.
It- tarf tal- beżżula għandu jitnaddaf sakemm ma jibqax jidher ħmieġ mal- imselħa.
Use a separate disinfectant towelette for each teat.
Uża sarvetta, li tiddiżinfetta, differenti għal kull beżżula.
Do not touch cleaned teat ends before administering the infusion substance.
Tmissx it- tarf nadif tal- beżżula qabel ma tamministra s- sustanza għal infużjoni.
Insertion:
Kif tapplika:
Remove the white end cap by pulling straight up.
Neħħi t- tapp l- abjad billi tiġbed dritt ‘ il fuq.
Gently insert the cannula into the teat canal; carefully infuse the product.
Daħħal il- kannula bil- mod fil kanal tal - beżżula; bil- mod agħti l- prodott b’ infużjoni.
Push plunger with continuous pressure gently and slowly to dispense entire contents into the gland and massage the quarter to distribute the product into the milk cistern.
Imbotta l- planġer b’ pressjoni kontinwa u bil- mod biex tgħaddi l- kontenut kollu għal ġol- glandola u mmassaġġja id- driegħ biex tferrex il- prodott ma kull fejn jinġabar il- ħalib.
Following infusion, dip all teats with a disinfectant teat dip.
Wara l- infużjoni, uża diżinfettant biex tbill il- bżieżel.
No data on overdosing are available.
M’ hemmx tagħrif dwar doża eċċesiva.
4.11 Withdrawal period(s)
4. 11 Perjodu( i) ta 'tiżmim
Meat and offal:
Laħam u interjuri:
23 days.
23 ġurnata.
Milk:
Ħalib: ħamest ijiem.
5 days.
5.
Antibacterial for intramammary use ATCvet code:
Kodiċi ATC veterinarja:
Pirlimycin hydrochloride is a semi-synthetic lincosamide antibiotic.
Pirlimycin hydrochloride huwa antibijotiku linkosamid semi- sintetiku.
The lincosamides (clindamycin, lincomycin, and pirlimycin) inhibit protein synthesis in Gram-positive and in anaerobic bacteria as well as in Mycoplasma spp.
Il- linkosamidi (clindamycin, lincomycin, u pirlimycin) jimblokkaw is- sintesi ta ’ proteini f’ mikrobi Gram- positive u anerobiċi kif ukoll fi speċi ta ’ Mycoplasma.
They work by binding to the 50S ribosomal subunit, therefore hindering the aminoacyl-tRNA binding and inhibiting the peptidyltransferase reaction, which interferes with protein synthesis within the bacteria.
Huma jaħdmu billi jeħlu mal- 50S ribosomal subunit, u b’ hekk ifixklu l- għaqda tal- aminoacyl- tRNA u jimblokkaw ir- reazzjoni tal- peptidyltransferase, li tfixkel is- sintesi ta ’ proteini fil- mikrobi.
3 Gram-positive isolates with an MIC > 2 µg/ ml are to be considered resistant.
3 Iżolati batterjoloġiċi ta ’ mikrobi Gram- positive b’ MIC > 2 mg/ ml huma meqjusa bħala reżistenti.
Enteric bacteria such as E. coli are intrinsically resistant to pirlimycin.
Mikrobi ta ’ l- imsaren bħal E. coli huma minn natura tagħhom reżistenti għal pirlimycin.
Pirlimycin has a basic pKa (8.5).
Pirlimycin għandu pKa bażiku (8. 5).
This means it will be more active in an acid environment and tends to concentrate, relative to plasma, in areas with lower pH, such as abscesses.
Dan ifisser li hu aktar attiv f’ ambjent aċiduż u jkun hemm tendenza li jikkonċentra, meta mqabbel mal- plażma, f’ postijiet li għandhom pH aktar baxx, bħal ma huma l- postijiet fejn hemm il- materja.
Pirlimycin has been shown to accumulate in polymorphonuclear cells, however, intracellular killing of Staphylococcus aureus was not demonstrated.
Pirlimycin ġie muri li jakkumula f’ ċelloli polimorfonukleari, imma ma ġiex muri li joqtol Staphylococcus aureus fiċ- ċelloli.
After intramammary infusion, mean parent concentrations in milk were 10.3 µg/ ml at 12 hours and 0.77 µg/ ml at 24 hours.
Wara infużjoni intramammarja, il- konċentrazzjonijiet medja tas- sustanza oriġinali fil- ħalib kienu ta ’ 10. 3 µg/ ml wara tnax il- siegħa u ta ’ 0. 77 µg/ ml wara erbgħa u għoxrin siegħa.
Similar concentrations were reached at 12 and 24 hours after a second infusion at a 24 hour interval.
Konċentrazzjonijiet simili intlaħqu wara tnax u erbgħa u għoxrin siegħa wara t- tieni infużjoni mgħotija wara intervall ta ’ erbgħa u għoxrin siegħa.
Of the dose infused, 10-13% is excreted in the urine, and 24-30% via the faeces; the remainder is excreted in the milk.
Mid- doża mogħtija fl- infużjoni, 10- 13% tiġi eliminata fl- urina, u 24- 30% fl - ippurgar; il- kumplament joħroġ fil- ħalib.
Anhydrous citric acid Sodium citrate Water for injection
Anhydrous citric acid Sodium citrate Ilma għal injezzjoni
6.3 Shelf life
Xejn li hu magħruf.
3 years
6. 3 Żmien ta 'kemm il- prodott idum tajjeb
Do not store above 25° C.
Taħżinx f’ temperatura ‘ il fuq minn 25°C.
Keep the syringes in the original container.
Żomm is- siringi fil- kontenitur oriġinali.
Sterile aqueous solution in 10 ml polyethylene intramammary syringes, packaged as 8 x 10 ml, 24 x 10 ml in an outer cardboard box.
Soluzzjoni sterili akweja f’ siringi intramammarji tal- polyethylene ta ’ 10 ml, ippakkjati f’ 8 x 10 ml, 24 x 10 ml f’ kaxxa tal- kartun.
Also packaged as 120 x 10 ml syringes in a plastic bucket.
Jiġu ppakkjati wkoll 120 x 10 ml siringa f’ barmil tal- plastik.
Any unused veterinary medical product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Mediċina veterinarja li ma ġietx użata jew materjal żejjed ġej minn dawn il- prodotti veterinarji, għandhom jintremew skond kif jitolbu ħtiġijiet lokali.
Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UK
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UK
29 January 2001
29 ta ’ Jannar 2001
THE MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SID/ S- SIDIEN TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL - LOTT
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SID (/ S- SIDIEN TA ’) L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
Name and address of the manufacturer responsible for batch release:
Isem u indirizz tal- manifattur responsabbli mill- ħruġ tal- lott
Rijksweg 12 2870 Puurs Belgium
Rijksweg 12 2870 Puurs Belġju
To be supplied only on veterinary prescription.
Prodott mediċinali veterinarju jingħata bir- riċetta.
Not applicable.
Ma jgħoddx
In accordance with Council Regulation (EEC) No 2377/ 90, as amended and in accordance with Article 34.4b of Regulation (EEC) No 726/ 2004 of 31 March 2004.
Skond ir- Regolament tal- Kunsill (KE) Nru 2377/ 90, kif emendat u skond l- Artikolu 34. 4b tar - Regolament (KE) Nru 726/ 2004 tal- 31 ta ’ Marzu 2004.
Pirlimycin is included in Annex I of Council Regulation (EEC) No 2377/ 90 in accordance with the following table:
Il- Kumitat għal Mediċini Veterinarji irrakkomanda li pirlimycin jiġi inkluż fl- Anness I tar- Regolament tal- Kunsill (KEE) Nru 2377/ 90 skond it- tabella li ġejja:
Pharmacologically
Sustanza( i) farmako - Residwu li jimmarka Speċje ta ’ loġikament attiva( i) l- annimal
active substance(s)
Tessuti Dispożizzjonijiet mmirati oħrajn
Muscle
Laħam
2377/ 90 for substances with an E- number2 (with the exception of preservatives listed in part C of Annex III to Council Directive 95/ 2/ EC3.).
Anhydrous citric acid (E 330) u Sodium citrate (E331) huma approvati bħala addittivi f’ prodotti tal - ikel għal konsum tal- bniedem u għalhekk jidhru fl- Anness II tar- Regolament tal- Kunsill (KEE) Nru 2377/ 90 għal sustanzi li għandhom E- number2 (ħlief preservanti li jidhru f’ Parti Ċ fl- Anness III tad - Direttiva tal- Kunsill 95/ 2/ EC3.).
1 OJ No L269 of 20.10.2000, p.
L269 ta ’ 20. 10. 2000, p.
21 2 OJ No L272 of 25.10.1996, p.
L272 ta ’ 25. 10. 1996, p.
2 3 OJ Nº L 61 of 18.3.1995, p.
L 61 ta ’ 18. 3. 1995, p.
8 x 10 ml syringes in an outer carton box 24 x 10 ml syringes in an outer carton box, including 3 package inserts 120 x 10 ml syringes in a plastic bucket, including 15 package inserts
8 siringi x 10 ml f’ kaxxa tal- kartun 24 siringi x 10 ml f’ kaxxa tal- kartun, bi tlett fuljetti ta ’ tagħrif 120 siringa x 10 ml f’ barmil tal- plastik, bi ħmistax- il fuljett ta ’ tagħrif
8 x 10 ml intramammary syringes 24 x 10 ml intramammary syringes 120 x 10 ml intramammary syringes
120 siringa intramammarja x 10 ml.
Cattle (lactating dairy cows)
Baqar (baqar tal- ħalib li qed jinħalbu).
For the treatment of subclinical mastitis in lactating cows due to Gram-positive cocci susceptible to pirlimycin including staphylococcal organisms such as Staphylococcus aureus, both penicillinase-positive and penicillinase-negative, and coagulase-negative staphylococci; streptococcal organisms including Streptococcus agalactiae, Streptococcus dysgalactiae and Streptococcus uberis.
Għal kura ta ’ mastite mingħajr sintomi, f’ baqar li qed jinħalbu, ikkawżata minn kokki Gram- positive li jirrispondu għall- pirlimycin, u dawn jinkludu mikrobi staphylokoċċi bħal Staphylococcus aureus, kemm l- istaphylokoċċi penicillinase- positive kif ukoll penicillinase- negative u coagulase- negative; mikrobi streptokoċċi li jinkludu Streptococcus agalactiae, Streptococcus dysgalactie u Streptococcus uberis.
Intramammary use.
Għal użu intramammarju.
Care must be taken not to introduce pathogens into the teat in order to reduce the risk of E. coli infections.
Għanda tingħata attenzjoni biex ma jiddaħħlux mikrobi fil- beżżula biex jitnaqqas ir- riskju ta ’ infezzjonijiet bi E. coli.
10 Insertion:
10 Kif tapplika:
Gently insert the cannula into the teat canal; carefully infuse the product.
Daħħal il- kannula bil- mod fil- kanal tal - beżżula; bil- mod agħti l- prodott b’ infużjoni.
5 days.
Ħalib: ħamest ijiem.
Keep the syringes in the outer carton.
Żomm is- siringi fil- kontenitur oriġinali.
Any unused veterinary medical product or waste materials derived from such medicinal products should be disposed of in accordance with the local requirements.
Mediċina veterinarja li ma ġietx użata jew materjal żejjed ġej minn dawn il- prodotti veterinarji, għandhom jintremew skond kif jitolbu ħtiġijiet lokali.
To be supplied only on veterinary prescription.
Prodott mediċinali veterinarju li għandu jingħata bir- riċetta.
Keep out of the reach and sight of children.
Sid ta ’ l- Awtorizzazzjoni biex il- prodott jitpoġġa fis- suq
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
11 Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UK
50 mg Pirlimycin
50 mg pirlimycin.
Intramammary use
Għal użu intramammarju.
Withdrawal period:
Laħam u interjuri:
14 PACKAGE LEAFLET PIRSUE 5 mg/ ml intramammary solution for cattle
14 FULJETT TA ’ TAGĦRIF FIL- PAKKETT PIRSUE 5 mg/ ml soluzzjoni intramammarja għal- baqar.
PIRSUE 5 mg/ ml intramammary solution for cattle
PIRSUE 5 mg/ ml soluzzjoni intramammarja għal baqar
For the treatment of subclinical mastitis in lactating cows due to Gram-positive cocci susceptible to pirlimycin including staphylococcal organisms such as Staphylococcus aureus, both penicillinase-positive and penicillinase-negative, and coagulase-negative staphylococci; streptococcal organisms including Streptococcus agalactiae, Streptococcus dysgalactiae, and Streptococcus uberis.
Għal kura ta ’ mastite mingħajr sintomi, f’ baqar li qed jinħalbu, ikkawżata minn kokki Gram- positive li jirrispondu għall- pirlimycin, u dawn jinkludu mikrobi stafilokoċċi bħal Staphylococcus aureus, kemm l- istafilokoċċi penicillinase- positive kif ukoll penicillinase- negative u coagulase- negative; mikrobi streptokoċċi li jinkludu Streptococcus agalactiae, Streptococcus dysgalactie u Streptococcus uberis.
Treatment of infections due to Gram-negative bacteria such as E. coli.
Kura għal infezzjonijiet ikkawżati minn mikrobi ta ’ l- imsaren bħal E. coli.
The treatment consists of eight infusions of one syringe every 24 hours.
Il- kura tikkonsisti fi tmien infużjonijiet ta ’ siringa waħda kull erbgħa u għoxrin siegħa.
Care must be taken not to introduce pathogens into the teat in order to reduce the risk of E. coli infections.
Għanda tingħata attenzjoni biex ma jiddaħħlux mikrobi fil- beżżula.
The following instructions should therefore be followed carefully.
It- tagħrif li ġej għandu jiġi segwit sew.
Where necessary, wash the teats thoroughly with warm water containing a suitable dairy cleansing agent and dry them thoroughly.
Fejn ikun hemm bżonn aħsel il- bżieżel sew b- ilma fietel li jkun fih sustanza apposta għal ħasil u ixxutthom sew.
Use a separate disinfectant towelette for each teat.
Uża sarvetta li tiżinfetta differenti għal kull beżżula.
Do not touch cleaned teat ends before administering the infusion substance.
Tmisx it- tarf nadif tal- beżżula qabel ma tamministra is- sustanza għal infużjoni.
Keep out of the reach and sight of children Do not store above 25° C.
Taħżinx f’ temperatura ‘ il fuq minn 25°C.
Do not use after the expiry date stated on the label and the container.
Tużax wara d- data ta ’ l- iskadenza fuq it- tiketta u fuq il- kontenitur.
Cross-resistance may occur between pirlimycin and other lincosamides or macrolides.
Jista ’ jkun hemm reżistenza inkroċjata bejn il- pirlimycin u linkosamidi oħra jew makrolidi.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY 16 Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Mediċina veterinarja li ma ġietx użata jew materjal żejjed ġej minn dawn il- prodotti veterinarji, għandhom jintremew skond kif jitolbu ħtieġijiet lokali.
Not all pack sizes may be marketed
Mhux id- daqs tal- pakketti kollha jistgħu qegħdin fis- suq
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Għal kull tagħrif dwar dan il- prodott mediċinali veterinarju, jekk jogħġbok ikkuntattja lir - rappreżentant lokali tas- Sid ta ’ l- Awtoriżżazzjoni tal- Kummerċ.
España Pfizer S. A.
17 España Pfizer S. A.
Route of administration
Mod ta ’ Amministrazzjo ni
Withdrawal period
Daqs tal - Perjodu pakkett ta ’ Tiżmim
≥ 5.9 log2 TN titre protein dO ≥ 4.2 log2 Agglutination titre Inactivated Bordetella bronchiseptica cells
Ċelloli inattivati ta ’ Bordatella bronchisept ica
Pigs (sows, gilts)
Majjala u majjala ta ’ l- ewwel
20 ml (10 doses)
20ml (10 dożi)
1 vial per cardboard box
Kunjett wieħed f’ kaxxa tal- kartun
≥ 5.9 log2 TN titre protein dO ≥ 4.2 log2 Agglutination titre Inactivated Bordetella bronchiseptica cells
≥5. 9 log2 TN tajter proteina dO ≥4. 2 log2.
Suspension for injection
Ċelloli
Pigs (sows, gilts)
Suspensjoni għal injezzjoni
Intramuscular use
Majjala u majjala ta ’ Fil- muskolu l- ewwel
50 ml (25 doses)
50ml (25 dożi)
EU/ 2/ 00/ 026/ 003 Porcilis AR-T DF
Għamla Farmaċewtika
≥ 5.9 log2 TN titre protein dO ≥ 4.2 log2 Agglutination titre Inactivated Bordetella bronchiseptica cells
Speċi li fuqhom għandu jintuża l - prodott
Suspension for injection
Mod ta ’ Amministrazzjo ni
Pigs (sows, gilts)
Perjodu ta ’ Tiżmim
Intramuscular use
EU/ 2/ 00/ 026/ 003 Porcilis AR- T DF ≥5. 9 log2
Vial (polyethylene terephthalate [PET])
Suspensjoni għal Majjala u majjala ta ’
20 ml (10 doses)
Fil- muskolu
1 vial per cardboard box
Kunjett
EU/ 2/ 00/ 026/ 004 Porcilis AR-T DF
TN tajter proteina dO ≥4. 2 log2 Tajter agglut.
≥ 5.9 log2 TN titre protein dO ≥ 4.2 log2 Agglutination titre Inactivated Bordetella bronchiseptica cells
l- ewwel
Suspension for injection
(polyethlene dożi) terephthalate [PET])
Pigs (sows, gilts)
wieħed f’ kaxxa tal- kartun
Intramuscular use
EU/ 2/ 00/ 026/ 004 Porcilis AR- T DF ≥5. 9 log2
Vial (polyethylene terephthalate [PET])
Suspensjoni għal Majjala u majjala ta ’ Fil- muskolu
50 ml (25 doses)
50ml (25 Kunje
1 vial per cardboard box
Kunjett 50ml (25 Kunjett
CVMP/ 670/ 00
Ċelloli
1/ 1
injezzjoni
©EMEA 2006
l- ewwel
What is Porcilis AR-T DF?
X’ inhu Porcilis AR- T DF?
Porcilis AR-T DF is a vaccine for use in pigs.
Porcilis AR- T DF hu tilqima għall- ħnieżer.
It is a vial containing a suspension for injection.
Jiġi bħala sospensjoni għall- injezzjoni.
Porcilis AR-T DF contains a non-toxic recombinant derivative (see ‘ How does Porcilis AR-T DF work? ’) of the Pasteurella multocida toxin and inactivated Bordetella bronchiseptica cells.
Porcilis AR- T DF fih derivattiv rekombinanti mhux tossiku (ara ‘ Kif jaħdem Porcilis AR- T DF? ’) tat- tossina tal - Pasteurella multocida.
What is Porcilis AR-T DF used for?
Għal xiex jintuża Porcilis AR- T DF?
Porcilis AR-T DF is used to reduce the clinical signs of progressive atrophic rhinitis (a disease where the nose tissues become infected and die) in piglets.
Porcilis AR- T DF jintuża fit- tnaqqis tas- sinjali kliniċi tar- rinite atrofika progressiva (marda fejn it - tessuti ta ’ l- imnieħer jiġu infettati u jmutu) fil- qżieqeż.
The vaccine is given to sows (female pigs) only.
It- tilqima tingħata lill- ħnieżer nisa biss.
Their piglets then become immunised when they drink the colostrum (first milk).
Il- frieħ tagħhom imbagħad jitlaqqmu meta jixorbu l- kolostru (il- ħalib tal- bidu).
Porcilis AR-T DF is given as a dose of 2 ml by intramuscular (into a muscle) injection to female pigs of 18 weeks of age and older.
Porcilis AR- T DF jingħata bħala doża ta ’ 2 ml b’ injezzjoni fil- muskolu lil ħnieżer nisa ta ’ 18- il ġimgħa jew iktar.
The vaccine is given just behind the ear.
It- tilqima tingħata eżatt wara l- widna.
The first injection should be given 6 weeks before the expected date of farrowing (giving birth to the piglets).
L- ewwel injezzjoni għandha tingħata 6 ġimgħat qabel id- data mistennija għat- tifrigħ (it- twellid tal- frieħ).
The first dose is followed by a second injection 4 weeks later.
L- ewwel doża tiġi segwita bit- tieni injezzjoni 4 ġimgħat wara.
To maintain the immunity, a single injection of one dose should be carried out 2 – 4 weeks before each subsequent farrowing.
Biex tinżamm l- immunità, għandha tingħata injezzjoni waħda bejn ġimagħtejn u 4 ġimgħat wara kull tifrigħ ta ’ wara.
How does Porcilis AR-T DF work?
Kif jaħdem Porcilis AR- T DF?
Progressive atrophic rhinitis is caused by toxins from the bacteria Pasteurella multocida.
Ir- rinite atrofika progressiva tiġi kkawżata b’ tossini mill- batterju Pasteurella multocida.
Porcilis AR-T DF contains a non-toxic recombinant derivative (see later) of the Pasteurella multocida toxin and also inactivated Bordetella bronchiseptica bacterial cells.
Porcilis AR- T DF ikun fih derivattiv rekombinanti mhux tossiku (ara iktar ’ l isfel) ta ’ Pasteurella multocida u wkoll taċ- ċelloli batteriċi ta ’ Bordetella bronchiseptica.
This bacterium is often present with Pasteurella multocida and makes the disease worse.
Dan il- batterju ħafna drabi jkun preżenti ma ’ Pasteurella multocida u jagħmel il- marda agħar.
When the sow is injected, this small exposure helps the pig’ s immune system to recognise and attack the bacteria.
Meta l- ħanżira tiġi injettata, il- fatt li tkun esposta b’ dan il- mod jgħin lis- sistema immunitarja tagħraf u tattakka l- batterji.
When exposed to any of these bacteria later in life, the pig will either not become infected or have a much less serious infection.
Meta jiġu esposti għal dawn il - batterji iktar tard fil- ħajja, il- ħnieżer jew ma jiġux infettati jew ikollhom infezzjoni ħafna inqas serja.
This immunity is passed onto the sow’ s piglets through her colostrum.
Din l- immunità tgħaddi għand il- frieħ tal- ħanżira mill- kolostru tagħha.
An active ingredient of Porcilis AR-T DF, Pasteurella multocida toxin, is produced by a method known as ‘ recombinant technology’.
Wieħed mill- ingredjenti attivi f’ Porcilis AR- T DF, it- tossina ta ’ Pasteurella multocida, jiġi prodott b’ metodu magħruf bħala ‘ teknoloġija rekombinanti ’.
The Pasteurella multocida toxin is made by a bacterium cell that has received a gene (DNA), which makes it able to produce Pasteurella multocida toxoid, a genetically modified form of toxin which has adequate immunogenic activity and which is free from the toxic properties.
It- tossina ta ’ Pasteurella multocida hi magħmula mit- tossojde ta ’ Pasteurella multocida, forma modifikata ġenetikament tat- tossina li jkollha attività immunoġenika adegwata u li ma jkolliex karatteristiċi tossiċi.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 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 the effectiveness of Porcilis AR-T DF been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 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 ġiet studjata l- effikaċja ta ’ Porcilis AR- T DF?
Porcilis AR-T DF has been studied in sows, where it was compared with another vaccine for progressive atrophic rhinitis.
Porcilis AR- T DF ġie studjat fi ħnieżer nisa, fejn tqabbel ma ’ tilqima oħra għar- rinite atrofika progressiva.
In this study, blood was taken from piglets in each litter born from each sow, and tested for antibodies to Pasteurella multocida toxin and Bordetella bronchiseptica.
F’ dan l- istudju, ittieħed demm mill- frieħ tal- ħnieżer f’ kull boton li jitwieled minn kull ħanżira, u dan ġie ttestjat għall- antikorpi għat- tossina ta ’ Pasteurella multocida u ta ’ Bordetella bronchiseptica.
The length of time that Porcilis AR-T DF is effective has also been studied.
Ġie studjat ukoll kemm jibqa ’ effettiv Porcilis AR- T DF.
The main measure of effectiveness was the amount of antibodies to Bordetella bronchiseptica and also to Pasteurella multocida toxin.
Il- mezz ewlieni tal- kejl ta ’ l- effikaċja kien l - ammont ta ’ antikorpi għal Bordetella bronchiseptica u wkoll għat- tossina ta ’ Pasteurella multocida.
What benefit has Porcilis AR-T DF shown during the studies?
X’ benefiċċji wera Porcilis AR- T DF waqt l- istudji li ġew imwettqa?
The trials showed good protection against the clinical signs of progressive atrophic rhinitis.
L- istudji wrew protezzjoni tajba kontra s- sinjali kliniċi tar- rinite atrofika progressiva.