PASTOBOV

Main information

  • Trade name:
  • PASTOBOV
  • Pharmaceutical form:
  • Suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PASTOBOV
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Pasteurella
  • Therapeutic area:
  • Cattle

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0101/001
  • Authorization date:
  • 25-01-2012
  • EU code:
  • FR/V/0101/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

June2007

SUMMARYOFPRODUCTCHARACTERISTICS

June2007

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PASTOBOV

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Mannheimiahaemolytica*typeA1antigen:leucotoxinminimumof............................68ELISA.U**

*Mannheimia haemolyticawasformerlycalledPasteurella haemolytica

**1ELISA.U:q.s.toobtainaMannheimiahaemolyticaantibodytitreof1ELISAunitinmiceaftertwo

administrationsofvaccine

Adjuvant(s):

Aluminium(ashydroxide)......................................................................................................4.2mg

Excipient(s):

Thiomersal............................................................................................................................0.2mg

Excipient.........................................................................................................q.s.p.1doseof2ml

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Suspensionforinjection–Milkybeige

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle.

4.2 Indicationsforuse,specifyingthetargetspecies

ActiveimmunisationofcattletoreduceclinicalsignsandlesionsofMannheimiahaemolytica*A1

inducedrespiratorydisease.

4.3 Contraindications

None

4.4 Specialwarnings

None

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Shakewellbeforeuse.

Applyusualasepticprocedures

Vaccinateonlyhealthyanimals

Applyusualproceduresforthehandlingoftheanimals.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Inthecaseofaccidentalself-injection,seekmedicaladviceimmediatelyandshowthepackageinsert

orthelabeltothephysician.

4..6Adversereactions(frequencyandseriousness)

Vaccinationbythesubcutaneousrouteisfollowedbyalimited2-5cmlocalreaction(oedema

developingasanodule)thatregresseswithin3weeks.Vaccinationbytheintramuscularroutecan

causeatransient,diffuseoedemaandslightlocalreactionupto5cmdiameterthatregresseswithin1-

2weeks.Aftersubcutaneousandintramuscularinjectiongranulomasupto5cmdiametermayoccur.

Vaccination(bythesubcutaneousorintramuscularroute)maysometimesinduceslight(1°C)transient

(24-72hours)hyperthermiaandalsohypersensitivityreactions.

4.7 Useduringpregnancy,lactationorlay

Pregnancy:Canbeusedduringpregnancy.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noinformationisavailableonthesafetyandefficacyfromtheconcurrentuseofthisvaccinewithany

other.Itisthereforerecommendedthatnoothervaccinesshouldbeadministeredwithin14daysbefore

oraftervaccinationwiththeproduct.

4.9 Amountstobeadministeredandadministrationroute

Intramuscularorsubcutaneousroute.

Injectone2-mldoseaccordingtothefollowingschedule:

- Primaryvaccinationpreferablybeforetheriskperiod

Firstinjection:attheminimumageof4weeks.

Secondinjection:21-28dayslater.

- Boostervaccinationinjectionpreferablybeforeeachriskperiod:

oneinjectionnolaterthanoneyearafterthepreviousvaccination.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Vaccinationwithadoubledosebythesubcutaneousrouteisfollowedbyalimited2-5cmlocalreaction

(oedemadevelopingasanodule)thatregresseswithin3weeks.Vaccinationwithadoubledosebythe

intramuscularroutecancauseatransient,diffuseoedemaandslightlocalreactionupto5cmdiameter

thatregresseswithin1-2weeks.Aftersubcutaneousandintramuscularinjectiongranulomasupto5

cmdiametermayoccur.Forbothsubcutaneousorintramuscularroute,slight(1°C)transient(24-72

hours)hyperthermiacouldbeobserved.

4.11Withdrawalperiod(s)

Zerodays.

5. IMMUNOLOGICALPROPERTIES

Adjuvanted,inactivatedvaccineagainstMannheimiahaemolytica*A1respiratoryinfectionsofcattle.

ThevaccineinducesanimmuneresponseagainstMannheimiahaemolytica*A1demonstratedby

challengeandbythepresenceofantibodiesagainsttheMannheimiahaemolytica*capsularand

leucotoxinantigens.Boostervaccinationresultsinananamnesticresponseintheantibodiesagainst

Mannheimiahaemolytica*capsularandleucotoxinantigens.

*Mannheimia haemolyticawasformerlycalledPasteurella haemolytica

ATCvetcode:QI02AB04

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Aluminiumhydroxide

Thiomersal

Salts

Waterforinjection

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

6.3 Shelflife

Shelflife:18months

Anyopenbottleshouldbeusedwithinoneworkingday.

6.4.Specialprecautionsforstorage

Storeandtransportbetween+2°Cand+8°C,protectedfromlight.Donotfreeze.

6.5 Natureandcompositionofimmediatepackaging

TypeIglassbottle

Butylelastomerclosure.

Aluminiumcap

Boxof1dose-glassbottle.

Boxof5dose-glassbottle.

Boxof10dose-glassbottle.

Boxof10glassbottlesof1dose.

Boxof50glassbottlesof1dose.

Boxof100glassbottlesof1dose.

Boxof10glassbottlesof5doses.

Boxof10glassbottlesof10doses.

Notallpacksizesmaybemarketed

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

7. MARKETINGAUTHORISATIONHOLDER

GERMANY

MERIALGmbH

AmSöldnermoos6,85399HALLBERGMOOS

Germany

(49)81195930

(49)8119593101

FRANCE,FINLANDandAUSTRIA

MERIAL

29,avenueTonyGarnier,69007LYON

France

(33)472723000

(33)472723069

THENETHERLANDS

MERIALBV

Kleermakerstraat10,1991JLVelserbroek

TheNetherlands

(31)23520.10.80

(31)23520.10.88

ITALY

MERIALITALIASPA

Milanofiori,Strada6,PalazzoE/5,20090Assago(MI)

Italy

(39)02577661

(39)0257766301

IRELANDandUNITED-KINGDOM

MERIALANIMALHEALTHLTD

POBox327,SandringhamHouse,HarlowBusinessPark,HARLOWEssexCM195TG

United-Kingdom

(44)1279775858

(44)1279775888

SPAIN

MERIALLABORATORIOSSA

c/Tarragona,161-LocalesD/E,08014BARCELONA

Spain

(34)932928383

(34)932928389

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Firstauthorisation:15/09/1995

Renewaloftheauthorisation:2003

Renewaloftheauthorisation:2007

10. DATEOFREVISIONOFTHETEXT

June2007

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Conditionofsupply: subjecttomedicalprescription

June2007

LABELLINGANDPACKAGELEAFLET

A.LABELLING

June2007

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Boxof1bottleof1dose

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Pastobov

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Mannheimiahaemolytica*typeA1antigen:leucotoxinminimumof..............................68ELISA.U

Thiomersal............................................................................................................................0.2mg

Aluminium(ashydroxide)......................................................................................................4.2mg

Excipientq.s.1doseof2ml

*MannheimiahaemolyticawasformerlycalledPAsteurellahaemolytica.

3. PHARMACEUTICALFORM

Suspensionforinjection

4. PACKAGESIZE

2-mlbottle,1dose

5. TARGETSPECIES

Cattle

6. INDICATION(S)

ActiveimmunisationofcattletoreduceclinicalsignsandlesionsofMannheimiahaemolytica*A1

inducedrespiratorydisease.

7. METHODANDROUTE(S)OFADMINISTRATION

Intramuscularorsubcutaneousroute.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Zerodays

9. SPECIALWARNING(S),IFNECESSARY

10. EXPIRYDATE

Exp.:

Anyopenbottleshouldbeusedwithinoneworkingday.

11. SPECIALSTORAGECONDITIONS

Storeandtransportbetween+2°Cand+8°C,protectedfromlight.Donotfreeze.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch:

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Boxof1bottleof5doses

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Pastobov

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Mannheimiahaemolytica*typeA1antigen:leucotoxinminimumof..............................68ELISA.U

Thiomersal............................................................................................................................0.2mg

Aluminium(ashydroxide)......................................................................................................4.2mg

Excipientq.s.1doseof2ml

*MannheimiahaemolyticawasformerlycalledPasteurellahaemolytica.

3. PHARMACEUTICALFORM

Suspensionforinjection

4. PACKAGESIZE

10-mlbottle,5doses

5. TARGETSPECIES

Cattle

6. INDICATION(S)

ActiveimmunisationofcattletoreduceclinicalsignsandlesionsofMannheimiahaemolytica*A1

inducedrespiratorydisease.

7. METHODANDROUTE(S)OFADMINISTRATION

Intramuscularorsubcutaneousroute.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Zerodays

9. SPECIALWARNING(S),IFNECESSARY

10. EXPIRYDATE

Exp.:

Anyopenbottleshouldbeusedwithinoneworkingday.

11. SPECIALSTORAGECONDITIONS

Storeandtransportbetween+2°Cand+8°C,protectedfromlight.Donotfreeze.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly

Tobesuppliedonlyonveterinaryprescription

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch:

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Boxof1bottleof10doses

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Pastobov

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Mannheimiahaemolytica*typeA1antigen:leucotoxinminimumof..............................68ELISA.U

Thiomersal............................................................................................................................0.2mg

Aluminium(ashydroxide)......................................................................................................4.2mg

Excipientq.s.1doseof2ml

*MannheimiahaemolyticawasformerlycalledPasteurellahaemolytica.

3. PHARMACEUTICALFORM

Suspensionforinjection

4. PACKAGESIZE

20-mlbottle,10doses

5. TARGETSPECIES

Cattle

6. INDICATION(S)

ActiveimmunisationofcattletoreduceclinicalsignsandlesionsofMannheimiahaemolytica*A1

inducedrespiratorydisease.

7. METHODANDROUTE(S)OFADMINISTRATION

Intramuscularorsubcutaneousroute.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Zerodays

9. SPECIALWARNING(S),IFNECESSARY

10. EXPIRYDATE

Exp.:

Anyopenbottleshouldbeusedwithinoneworkingday.

11. SPECIALSTORAGECONDITIONS

Storeandtransportbetween+2°Cand+8°C,protectedfromlight.Donotfreeze.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly

Tobesuppliedonlyonveterinaryprescription

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch:

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Boxof10bottlesof1dose

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Pastobov

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Mannheimiahaemolytica*typeA1antigen:leucotoxinminimumof..............................68ELISA.U

Thiomersal............................................................................................................................0.2mg

Aluminium(ashydroxide)......................................................................................................4.2mg

Excipientq.s.1doseof2ml

* Mannheimia haemolyticawasformerlycalledPasteurella haemolytica.

3. PHARMACEUTICALFORM

Suspensionforinjection

4. PACKAGESIZE

10bottlesof2ml,10x1dose

5. TARGETSPECIES

Cattle

6. INDICATION(S)

ActiveimmunisationofcattletoreduceclinicalsignsandlesionsofMannheimiahaemolytica*A1

inducedrespiratorydisease.

7. METHODANDROUTE(S)OFADMINISTRATION

Intramuscularorsubcutaneousroute.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Zerodays

9. SPECIALWARNING(S),IFNECESSARY

10. EXPIRYDATE

Exp.:

Anyopenbottleshouldbeusedwithinoneworkingday.

11. SPECIALSTORAGECONDITIONS

Storeandtransportbetween+2°Cand+8°C,protectedfromlight.Donotfreeze

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly

Tobesuppliedonlyonveterinaryprescription

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch:

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Boxof10bottlesof5doses

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Pastobov

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Mannheimiahaemolytica*typeA1antigen:leucotoxinminimumof..............................68ELISA.U

Thiomersal............................................................................................................................0.2mg

Aluminium(ashydroxide)......................................................................................................4.2mg

Excipientq.s.1doseof2ml

* Mannheimia haemolyticawasformerlycalledPasteurella haemolytica.

3. PHARMACEUTICALFORM

Suspensionforinjection

4. PACKAGESIZE

10bottlesof10ml,10x5doses

5. TARGETSPECIES

Cattle

6. INDICATION(S)

ActiveimmunisationofcattletoreduceclinicalsignsandlesionsofMannheimiahaemolytica*A1

inducedrespiratorydisease.

7. METHODANDROUTE(S)OFADMINISTRATION

Intramuscularorsubcutaneousroute.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Zerodays

9. SPECIALWARNING(S),IFNECESSARY

10. EXPIRYDATE

Exp.:

Anyopenbottleshouldbeusedwithinoneworkingday.

11. SPECIALSTORAGECONDITIONS

Storeandtransportbetween+2°Cand+8°C,protectedfromlight.Donotfreeze.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly

Tobesuppliedonlyonveterinaryprescription

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch:

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Boxof10bottlesof10doses

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Pastobov

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Mannheimiahaemolytica*typeA1antigen:leucotoxinminimumof..............................68ELISA.U

Thiomersal............................................................................................................................0.2mg

Aluminium(ashydroxide)......................................................................................................4.2mg

Excipientq.s.1doseof2ml

* Mannheimia haemolyticawasformerlycalledPasteurella haemolytica.

3. PHARMACEUTICALFORM

Suspensionforinjection

4. PACKAGESIZE

10bottlesof20ml,10x10doses

5. TARGETSPECIES

Cattle

6. INDICATION(S)

ActiveimmunisationofcattletoreduceclinicalsignsandlesionsofMannheimiahaemolytica*A1

inducedrespiratorydisease.

7. METHODANDROUTE(S)OFADMINISTRATION

Intramuscularorsubcutaneousroute.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Zerodays

9. SPECIALWARNING(S),IFNECESSARY

10. EXPIRYDATE

Exp.:

Anyopenbottleshouldbeusedwithinoneworkingday.

11. SPECIALSTORAGECONDITIONS

Storeandtransportbetween+2°Cand+8°C,protectedfromlight.Donotfreeze.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly

Tobesuppliedonlyonveterinaryprescription

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch:

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Boxof50bottlesof1dose

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Pastobov

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Mannheimiahaemolytica*typeA1antigen:leucotoxinminimumof..............................68ELISA.U

Thiomersal............................................................................................................................0.2mg

Aluminium(ashydroxide)......................................................................................................4.2mg

Excipientq.s.1doseof2ml

* Mannheimia haemolyticawasformerlycalledPasteurella haemolytica.

3. PHARMACEUTICALFORM

Suspensionforinjection

4. PACKAGESIZE

50bottlesof2ml,50x1dose

5. TARGETSPECIES

Cattle

6. INDICATION(S)

ActiveimmunisationofcattletoreduceclinicalsignsandlesionsofMannheimiahaemolytica*A1

inducedrespiratorydisease.

7. METHODANDROUTE(S)OFADMINISTRATION

Intramuscularorsubcutaneousroute.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Zerodays

9. SPECIALWARNING(S),IFNECESSARY

10. EXPIRYDATE

Exp.:

Anyopenbottleshouldbeusedwithinoneworkingday.

11. SPECIALSTORAGECONDITIONS

Storeandtransportbetween+2°Cand+8°C,protectedfromlight.Donotfreeze

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly

Tobesuppliedonlyonveterinaryprescription

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch:

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Boxof100bottlesof1dose

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Pastobov

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Mannheimiahaemolytica*typeA1antigen:leucotoxinminimumof..............................68ELISA.U

Thiomersal............................................................................................................................0.2mg

Aluminium(ashydroxide)......................................................................................................4.2mg

Excipientq.s.1doseof2ml

* Mannheimia haemolytica wasformerlycalledPasteurella haemolytica.

3. PHARMACEUTICALFORM

Suspensionforinjection

4. PACKAGESIZE

100bottlesof2ml,100x1dose

5. TARGETSPECIES

Cattle

6. INDICATION(S)

ActiveimmunisationofcattletoreduceclinicalsignsandlesionsofMannheimiahaemolytica*A1

inducedrespiratorydisease.

7. METHODANDROUTE(S)OFADMINISTRATION

Intramuscularorsubcutaneousroute.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Zerodays

9. SPECIALWARNING(S),IFNECESSARY

June2007

10. EXPIRYDATE

Exp.:

Anyopenbottleshouldbeusedwithinoneworkingday.

11. SPECIALSTORAGECONDITIONS

Storeandtransportbetween+2°Cand+8°C,protectedfromlight.Donotfreeze.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly

Tobesuppliedonlyonveterinaryprescription

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch:

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

Bottleof1dose

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Pastobov

SuspensionforInjection

Cattle

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

MannheimiahaemolyticatypeA1antigen:leucotoxin

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

2-mlbottle,1dose

4. ROUTE(S)OFADMINISTRATION

Intramuscularorsubcutaneousroute.

5. WITHDRAWALPERIOD

Zerodays

6. BATCHNUMBER

Batch

7. EXPIRYDATE

Exp.:

Anyopenbottleshouldbeusedwithinoneworkingday.

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

Bottleof5doses

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Pastobov

SuspensionforInjection

Cattle

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

MannheimiahaemolyticatypeA1antigen:leucotoxin

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

10-mlbottle,5doses

4. ROUTE(S)OFADMINISTRATION

Intramuscularorsubcutaneousroute.

5. WITHDRAWALPERIOD

Zerodays

6. BATCHNUMBER

Batch

7. EXPIRYDATE

Exp.:

Anyopenbottleshouldbeusedwithinoneworkingday.

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

Bottleof10doses

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Pastobov

SuspensionforInjection

Cattle

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

MannheimiahaemolyticatypeA1antigen:leucotoxin

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

20-mlbottle,10doses

4. ROUTE(S)OFADMINISTRATION

Intramuscularorsubcutaneousroute.

5. WITHDRAWALPERIOD

Zerodays

6. BATCHNUMBER

Batch

7. EXPIRYDATE

Exp.:

Anyopenbottleshouldbeusedwithinoneworkingday.

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

June2007

B.PACKAGELEAFLET

June2007

PACKAGELEAFLET

Pastobov

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

Manufacturerforthebatchrelease:

MERIALLaboratoiredePortedesAlpes,99ruedel'aviation,69800SAINT-PRIEST,France

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Pastobov

Suspensionforinjection–Milkybeige

Cattle

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Activesubstance:

Mannheimiahaemolytica*typeA1antigen:leucotoxinminimumof...............................68ELISA.U

*Mannheimia haemolyticawasformerlycalledPasteurella haemolytica

Adjuvant(s):

Aluminium(ashydroxide)......................................................................................................4.2mg

Thiomersal............................................................................................................................0.2mg

Excipient(s):

Excipient.........................................................................................................q.s.p.1doseof2ml

4. INDICATION(S)

ActiveimmunisationofcattletoreduceclinicalsignsandlesionsofMannheimiahaemolyticainduced

respiratorydisease.

5. CONTRAINDICATIONS

None.

6. ADVERSEREACTIONS

Vaccinationbythesubcutaneousrouteisfollowedbyalimited2-5cmlocalreaction(oedema

developingasanodule)thatregresseswithin3weeks.

Vaccinationbytheintramuscularroutecancauseatransient,diffuseoedemaandslightlocalreaction

upto5cmdiameterthatregresseswithin1-2weeks.

Aftersubcutaneousandintramuscularinjectiongranulomasupto5cmdiametermayoccur.

Vaccination(bythesubcutaneousorintramuscularroute)maysometimesinduceslight(1°C)transient

(24-72hours)hyperthermiaandalsohypersensitivityreactions.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

June2007

7. TARGETSPECIES

Cattle

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Intramuscularorsubcutaneousroute.

Injectone2-mldoseaccordingtothefollowingschedule:

-Primaryvaccinationpreferablybeforetheriskperiod.

Firstinjection:attheminimumageof4weeks.

Secondinjection:21-28dayslater.

-Boostervaccinationinjectionpreferablybeforeeachriskperiod.

Oneinjectionnolaterthanoneyearafterthepreviousvaccination.

9. ADVICEONCORRECTADMINISTRATION

Shakepriortouse.

Applyusualasepticprocedures.

Vaccinateonlyhealthyanimals.

Applyusualproceduresforthehandlingoftheanimals.

10. WITHDRAWALPERIOD

Zerodays

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Storeandtransportbetween2°Cand8°C,protectedfromlight.Donotfreeze.

Anyopenbottleshouldbeusedwithinoneworkingday.

Donotuseaftertheexpirydatestatedonthebottle.

12. SPECIALWARNING(S)

Specialprecautionsforanimals:

Pregnancy:Canbeusedduringpregnancy.

Noinformationisavailableonthesafetyandefficacyfromtheconcurrentuseofthisvaccinewith

anyother.Itisthereforerecommendedthatnoothervaccinesshouldbeadministeredwithin14

daysbeforeoraftervaccinationwiththeproduct.

Vaccinationwithadoubledosebythesubcutaneousrouteisfollowedbyalimited2-5cmlocal

reaction(oedemadevelopingasanodule)thatregresseswithin3weeks.Vaccinationwithadouble

dosebytheintramuscularroutecancauseatransient,diffuseoedemaandslightlocalreactionup

to5cmdiameterthatregresseswithin1-2weeks.Aftersubcutaneousandintramuscularinjection

granulomasupto5cmdiametermayoccur.Forbothsubcutaneousandintramuscularroute,slight

(1°C)transient(24-72hours)hyperthermiacouldbeobserved.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Inthecaseofaccidentalself-injection,seekmedicaladviceimmediatelyandshowthepackage

insertorthelabeltothephysician.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIAL,IFANY

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

June2007

15. OTHERINFORMATION

Adjuvanted,inactivatedvaccineagainstMannheimiahaemolytica*A1respiratoryinfectionsof

cattle.

Boxof1dose-glassbottle.

Boxof5dose-glassbottle.

Boxof10dose-glassbottle.

Boxof10glassbottlesof1dose.

Boxof50glassbottlesof1dose.

Boxof100glassbottlesof1dose.

Boxof10glassbottlesof5doses.

Boxof10glassbottlesof10doses.

Notallpacksizesmaybemarketed.

3-10-2018

Koning met minister De Jonge op werkbezoek in het kader van kwaliteit verpleeghuiszorg

Koning met minister De Jonge op werkbezoek in het kader van kwaliteit verpleeghuiszorg

Zijne Majesteit de Koning heeft woensdag 3 oktober 2018 samen met vicepremier en minister De Jonge van Volksgezondheid, Welzijn en Sport (VWS) een werkbezoek gebracht aan het Sint Elisabeth Verpleeg- en Gasthuis (EVG) in Amersfoort. Dit verpleeghuis is onderdeel van zorgorganisatie Beweging 3.0 en biedt zorg aan oudere mensen met dementie. Tijdens het werkbezoek stond centraal hoe een zorgorganisatie een kwaliteitsachterstand kan ombuigen naar kwalitatief goede zorg.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

27-6-2018

Dafiro HCT (Novartis Europharm Limited)

Dafiro HCT (Novartis Europharm Limited)

Dafiro HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4084 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1160/T/68

Europe -DG Health and Food Safety

6-6-2018

Prolia (Amgen Europe B.V.)

Prolia (Amgen Europe B.V.)

Prolia (Active substance: denosumab) - Centralised - 2-Monthly update - Commission Decision (2018) 3685 of Wed, 06 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1120/II/68

Europe -DG Health and Food Safety