Hipragumboro GM97

Main information

  • Trade name:
  • Hipragumboro GM97
  • Pharmaceutical form:
  • Oral suspension
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Hipragumboro GM97
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Avian infectious bursal disease virus vaccine (Gumboro disease)
  • Therapeutic area:
  • Chicken Broilers

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0191/001
  • Authorization date:
  • 20-05-2011
  • EU code:
  • UK/V/0191/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:May2011

AN:00040/2011

Page1of7

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT.

HIPRAGUMBORO-G97.

2. QUALITATIVEANDQUANTITATIVECOMPOSITION.

Compositionperdose:

Activesubstance:

-LiveInfectiousBursalDiseaseVirus,strainGM97:10 2

-10 3

EID

(embryoinfectivedose50%).

Excipientsandadjuvantswhereknowledgeofthisisessentialfor

thesafeadministrationofthemedicinalproduct:

None.

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM.

Lyophilisatefororalsuspension.

Appearance:reddishtablet.

4. CLINICALPARTICULARS.

4.1.Targetspecies.

Species:Chickens.

Category:Broilers.

4.2.Indicationsforuse,specifyingthetargetspecies.

Foractiveimmunisationofbroilerswithinsignificantlevelsofmaternally

derivedantibodies(ELISAof500orbelow)toreducemortality,clinical

signsandbursallesionsofGumborodisease.Suchbirdscanbe

vaccinatedfromonedayofage.Theonsetofimmunityis14dayspost

vaccinationandtheduration43dayspostvaccination.

4.3.Contraindications.

Donotvaccinatesickbirds.

Donotuseininfectedflocksshowingclinicalsigns.

Revised:May2011

AN:00040/2011

Page2of7

Sincenostudiestodemonstratethesafetyofthisvaccinewhenitis

administeredtolayersandbreedershavebeencarriedout,itsuseisnot

recommendedforthesecategoriesofthetargetspecies(seesection

4.7).

4.4.Specialwarningsforeachtargetspecies.

Useonlyinflockswithlowlevelsofmaternalantibodies(meanELISA

titres

500).Theoptimumdayofvaccinationofbroilerswithmaternal

antibodiesiscalculatedaccordingtotheKouwenhoven’sformula(see

section4.9.posology).

Duetoitsresidualpathogenicitytothebursathevaccineshouldbeused

onlyinareascontaminatedwithvvIBDV,exceptforinfectedflocks

showingclinicalsigns.

Seesection4.3.

4.5.Specialprecautionsforuse.

i.Specialprecautionsforuseinanimals

-Donotusewaterwithchlorineordisinfectantstoreconstitutethe

vaccine.

-Thevaccinestrainspreadstounvaccinatedchickens.

-Appropriateveterinaryandhusbandrymeasuresshouldbetakento

avoidspreadtosusceptiblespecies.

ii.Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals.

-Washanddisinfecthandsandequipmentafteruse.

-Inthecaseofaccidentalingestion,contactwiththeeyes,orspillage

ontotheskinseekmedicaladviceimmediatelyandshowthepackage

leafletorthelabeltothephysician.

4.6.Adversereactions(frequencyandseriousness).

Theadministrationofasingledosecauseslymphocytedepletioninthe

bursaofFabricius(in50-75%ofthefollicles).Lymphocyterepopulation

isobservedfrom14dayspostvaccinationonwards,at28dayspost

vaccinationthereisstillsomedepletionremaining(5-25%offollicles).

Thislymphocytedepletiondoesnotresultinanimmunosuppressive

effect.

4.7.Useduringpregnancy,lactationorlay.

Revised:May2011

AN:00040/2011

Page3of7

Donotuseinlayersandbreeders(seesection4.3).

Revised:May2011

AN:00040/2011

Page4of7

4.8.Interactionwithothermedicinalproductsandotherformsof

interaction.

Noinformationisavailableonthecompatibilityofthisvaccinewithany

other.Thereforethesafetyandefficacyofthisproductwhenusedwith

anyother(eitherwhenusedonthesamedayordifferenttimes)hasnot

beendemonstrated.

4.9.Amountstobeadministeredandadministrationroute.

Breakthevacuuminsidethevialbyinoculationof10mlofdrinkingwater

withoutchlorineordisinfectants.Shakegentlyuntilcomplete

resuspensionofthefreeze-driedpowderbeforeadministration.

Posology:

Serologicallynegativebirdscanbevaccinatedfromonedayofage.The

optimumageforvaccinationmaybecalculatedusingthelevelof

maternalantibodyinthechicksatdayold(Kouwenhoven’sformula)by

testingatleast18birds(preferably24)oftheflockaccordingtothe

followingtable.Allbirdsshouldbegivenasinglevaccinationonly.

MEANELISATITREAT1DAY

OFAGE OPTIMUMAGEFOR

VACCINATION(DAYS)

≤500 1

≤750 2-3

≤1000 4

≤1250 5-6

≤1500 7

≤2000 9

≤2500 11

≤3000 12-13

≤3500 14

≤4000 15-16

≤4500 17

≤5000 18

≤5500 19

≤6000 20

Methodofadministration:

Thevolumeofwaterforreconstitutiondependsontheageofthebirds

andthemanagementpractice.Generally,2litresofwaterper1,000

broilersforeverydayofageareneeded.Hence,1,00014daybroilers

wouldneed28litresofwatertoreconstitutethe1,000dosesofvaccine.

Ifthebirdshavehigherorlowerwaterrequirements,adjustthevolumes

accordingly.

Revised:May2011

AN:00040/2011

Page5of7

Thewayinwhichthisvaccineisadministerediscritical.Thefollowing

managementconsiderationshavebeenfoundtoimprovethevaccine

intake:

Watershouldbewithheldfor1-2hoursbeforevaccinationtoensurethat

allreconstitutedvaccineisconsumedwithin1-2hours.

Forbelldrinkers:goroundthehouseemptyingandcleaningthedrinkers

duringthewaterwithholdingperiod.Mixupthevaccineaccordingtothe

recommendationsandattheendofthewaterwithholdingperiodgo

roundallthedrinkersandfillthemwithwatercontainingvaccine.

Fornippledrinkers:aconsiderableamountofresidualwatermayremain

inthelinesafterthewaterwithholdingperiod.Itisrecommendedtodrain

thelinesandloadthemwithwaterwhichcontainsvaccinebefore

allowingthebirdstohaveaccesstothenipples.Mixupthevaccineand

applytothetank.Calculatethevolumethatisleftinthetankbelowthe

outletvalveandbesuretotakethisvolumeofwaterintoaccountwhen

calculatingthenumberofdosestobeadded.

Alwaysmakesurethatthereisfoodavailablewhenvaccinating(birds

willnotdrinkiftheyhavenofoodtoeat).Turnonmainswaterwhenallthe

watercontainingvaccinehasbeenconsumed.

4.10.Overdose(symptoms,emergencyprocedures,antidotes),if

necessary.

Theadministrationofa10folddosecauseslymphocytedepletioninthe

bursaofFabricius(inapproximately75%offollicles).Lymphocyte

repopulationisobservedfromday14onwardsandbyday28post

vaccinationlessthan25%offolliclesareaffected.

4.11.Withdrawalperiod.

Zerodays.

5. IMMUNOLOGICALPROPERTIES.

TostimulateactiveimmunityagainstInfectiousBursalDisease

(Gumborodisease)Virus.

ThevaccinestrainGM97inducesalesionscoreof1.7tothebursaof

Fabriciusobserved28daysafteradministrationof10maximumdoses.

ATCvetcode:QI01AD09

6. PHARMACEUTICALPARTICULARS.

6.1. Listofexcipients

-Disodiumphosphatedodecahydrate

-Potassiumdihydrogenphosphate

-Gelatin

Revised:May2011

AN:00040/2011

Page6of7

-Povidone30

-Sodiumchloride

-Potassiumchloride

-Monosodiumglutamate

-Sucrose

-Waterforinjections

6.2.Incompatibilities.

Donotmixwithanyothervaccineorimmunologicalproduct.

6.3.Shelf-life.

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:24

months.

Shelflifeafterdiluitionorreconstitutionaccordingtodirections:1hour.

6.4.Specialprecautionsforstorage.

Storeandtransportrefrigerated(2ºC-8ºC).

Protectfromlight.

6.5.Natureandcompositionofimmediatepackaging.

TypeIglassvials(EuropeanPharmacopoeia)of10mlcontaining1,000

dosesand5,000dosesofthefreeze-driedvaccine,TypeIbromobutyl

rubberstoppers(EuropeanPharmacopoeia)andaluminiumcaps.

PackSizes:

Packwith1vialof1000doses

Packwith1vialof5000doses

Packwith10vialsof1000doses

Packwith10vialsof5000doses

Notallpacksizesmaybemarketed.

6.6.Specialprecautionsforthedisposalofunusedveterinary

medicinalproductorwastematerialsderivedfromtheuseofsuch

products.

Disposeofwastematerialsbyboiling,incinerationorimmersioninan

appropriatedisinfectantapprovedforusebythecompetentauthorities.

Revised:May2011

AN:00040/2011

Page7of7

7. NAMEORCORPORATENAMEANDADDRESSORREGISTERED

PLACEOFBUSINESSOFTHEMARKETINGAUTHORISATION

HOLDER.

LABORATORIOSHIPRA,SA.

Avda.LaSelva,135.

17170-AMER(Girona)Spain.

8. MARKETINGAUTHORISATIONNUMBER

Vm 17533/4002

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION:

26.07.2002(UK)/26.11.2008

10. DATEOFREVISIONOFTHETEXT:

May2011

CONDITIONSOFSUPPLY/LEGALCATEGORY:

Tobesuppliedonlyonveterinaryprescription.

13-12-2018

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

Published on: Wed, 12 Dec 2018 This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of zoonoses monitoring activities carried out in 2017 in 37 European countries (28 Member States (MS) and nine non-MS). Campylobacteriosis was the commonest reported zoonosis and its EU trend for confirmed human cases increasing since 2008 stabilised during 2013–2017. The decreasing EU trend for confirmed human salmonellosis cases since 2008 end...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

FDA approves new treatment for patients with acute myeloid leukemia

FDA approves new treatment for patients with acute myeloid leukemia

The FDA approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy.

FDA - U.S. Food and Drug Administration

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Livestock Health and Food Chain Risk Assessment

Livestock Health and Food Chain Risk Assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EUFORA fellowship programme ‘Livestock Health and Food Chain Risk Assessment’ was proposed by the Animal and Plant Health Agency (APHA), a British governmental institution responsible for safeguarding animal and plant health in the UK. The working programme, which was organised into four different modules, covered a wide range of aspects related to risk assessment including identification of emerging risks, risk prioritisation methods, scanning surveilla...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

18-7-2018

Orphan designation:  Recombinant humanised anti-human interleukin-1 beta monoclonal antibody,  for the: Treatment of Behçet’s disease

Orphan designation: Recombinant humanised anti-human interleukin-1 beta monoclonal antibody, for the: Treatment of Behçet’s disease

On 1 October 2010, orphan designation (EU/3/10/796) was granted by the European Commission to XOMA Ireland Ltd, Ireland, for recombinant humanised anti-human interleukin-1 beta monoclonal antibody for the treatment of Behçet’s disease.

Europe - EMA - European Medicines Agency

15-5-2018

Watch out for ticks with the return of warmer weather!

Watch out for ticks with the return of warmer weather!

The return of warmer weather is particularly conducive to walks in natural surroundings, including woods and forests, as well as activities in the garden. It is therefore a good time to recall the precautions to take in order to avoid tick bites – also unfortunately in season. Especially active in the spring and autumn, ticks remain the most common vectors of pathogens responsible for infectious diseases in Europe. A single bite is enough to transmit the Lyme disease bacterium, the main tick-borne diseas...

France - Agence Nationale du Médicament Vétérinaire

13-9-2018

 European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, From: 03-Dec-2018, To: 03-Dec-2018

European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, From: 03-Dec-2018, To: 03-Dec-2018

This workshop on the development of medicines for chronic non-infectious liver diseases, including primary biliary cholangitis, primary sclerosing cholangitis and nonalcoholic steatohepatitis, provides a platform for discussion on appropriate endpoints including validation of surrogate endpoints/biomarkers, suitable study populations, potentially adequate trial designs and the specific challenges with paediatric medicine development. The workshop will support the drafting of a reflection paper on regul...

Europe - EMA - European Medicines Agency

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

30-7-2018

Zalmoxis (MolMed S.p.A.)

Zalmoxis (MolMed S.p.A.)

Zalmoxis (Active substance: Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (?LNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)) - Centralised - Renewal - Commission Decision (2018)5118 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2801/R/10

Europe -DG Health and Food Safety

19-6-2018

Aftovaxpur Doe (Merial)

Aftovaxpur Doe (Merial)

Aftovaxpur Doe (Active substance: purified, inactivated foot-and-mouth disease virus strains O1 Manisa, O1 BFS, O Taiwan 3/97, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia 1 Shamir, SAT2 Saudi Arabia) - Centralised - Renewal - Commission Decision (2018)3891 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2292/R/8

Europe -DG Health and Food Safety