Pigzin Premix

Main information

  • Trade name:
  • Pigzin Premix
  • Pharmaceutical form:
  • Premix for medicated feed
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Pigzin Premix
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • zinc oxide
  • Therapeutic area:
  • Pigs Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0487/001
  • Authorization date:
  • 13-12-2012
  • EU code:
  • UK/V/0487/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:May2013

AN:00905/2012

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PigzinPremix,100% w

Premixformedicatedfeedingstuff

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Qualitativecomposition

ZincOxide

Forfulllistofexcipientsseesection

6.1 Quantitativecomposition

100% w

/

w

3. PHARMACEUTICALFORM

Premixformedicatedfeedingstuff

Asoft,whiteorfaintlyyellowishwhiteamorphouspowder.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigsupto10weeksofage

4.2 Indicationsforuse,specifyingthetargetspecies

Forthetreatmentandcontrolofdiarrhoeainpigs

4.3 Contraindications

Noneknown

4.4 Specialwarningsforeachtargetspecies

Noneknown

4.5 Specialprecautionsforuse

i.Specialprecautionsforuseinanimals

Noneknown

ii.Specialprecautionsforthepersonadministeringtheveterinary

medicinalproducttoanimals

Revised:May2013

AN:00905/2012

Weareitheradisposablehalf-maskrespiratorconformingto

EuropeanStandardEN149oranon-disposablerespiratorto

EuropeanStandardEN140withafiltertoEN143whenmixingor

handlingthefeed.

Avoidcontactwiththeskinbywearingprotectiveclothing,including

impermeablegloves.Incaseofaccidentalskincontact,washthe

exposedskinwithsoapandwater.

Avoidcontactwiththeeyesbywearingprotectivegogglesorsafety

glasses.Incaseofaccidentaleyecontactirrigatethoroughlywith

largequantitiesofwater.

Contaminatedclothingshouldberemovedandwashedbefore

beingreused.

Incaseofaccidentalingestion,drinkplentyofwaterandseek

medicalattention.

Washhandsafteruse.

iii.

Otherprecautions

Noneknown

4.6 Adversereactions(frequencyandseriousness)

Noneknown

4.7 Useduringpregnancy,lactationorlay

Notapplicable

4.8 Interactionwithothermedicinalproductsandotherformsof

interaction

Noneknown

4.9 Amount(s)tobeadministeredandadministrationroute

Fororaladministrationonly

Forincorporationintodryfeedataregistered/licensedmill.Formore

information:

IntheUKrefertoVMGNNo3,GuidanceforRetailers,

Revised:May2013

AN:00905/2012

InIrelandseekadvicefromtheDepartmentofAgriculture,Food

andtheMarine.

Administer2900-3100mg/kgPigzinPremix(whichprovides2320-2489

mg/kgelementalzinc)sothattheamountofzincalreadypresentinthe

feed(naturallyoccurringzincplusaddednutritionalzinc)istakenaccount

oftoensurethatthefinalfeedcontains2500mg/kgofelementalzinc.

Toensureadequatedistributionoftheproductinthefinalfeeditis

recommendedthatitbepremixedwithasuitablequantityoffeed

ingredientsbeforeblendingintothefinalfeed.Thefinalfeedshouldbe

fedastheonlyfeedforupto14days.

4.10 Overdose(symptoms,emergencyprocedures,antidotes),if

necessary

Noknownproblems.

4.11 Withdrawalperiod(s)

Animalsmustnotbeslaughteredforhumanconsumptionduring

treatment.Animalsmaybeslaughteredforhumanconsumptiononlyafter

28daysaftertheendoftreatment.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:

Anti-diarrhoeal

ATCVetCode:QA07XA91

5.1 Pharmacodynamicproperties

Themodeofactionofzincoxideinthetreatmentandcontrolofdiarrhoea

hasnotbeendetermined.Ithasbeenshowntohaveafavourableeffect

onthegutmicroflorabyhelpingtopreventthereductionindiversityof

microflorathatoccurredintheintestinesofcontrolpigsduringthesecond

weekafterweaning.

5.2 Pharmacokineticproperties

Absorption –Zincisanessentialtraceelementforlivestockrequiredfor

themaintenanceofdailybodilyfunction.Zincoxideisknowntobe

relativelypoorlyabsorbedandtherapeuticlevelshaveincreasedblood

levelsbyafactoroftwo.

Distribution –Therapeuticlevelsofzincoxidefedforfourweeksafter

weaninghavebeenshowntoincreasezinclevelsintheliverandkidney

Revised:May2013

AN:00905/2012

ofpigsbyafactorofapproximatelyfiveandtworespectively.No

increasesinmusclelevelswerenoted.

Biotransformation –Zincisatraceelementessentialfordailymetabolism

inthebody.Sincetherapeuticlevelsarepoorlyabsorbed,itisbelieved

thatmostisvoidedunchangedinthefaeces.

Elimination –Mostzincfromzincoxideisexcretedwithoutabsorption.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

None

6.2 Incompatibilities

Noneknown

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:2

Years.

Shelflifeafterincorporationintomealorpelletedfeed:3Months

6.4 Specialprecautionsforstorage

Storeinacleandryplace.Donotstoreabove25°C

Storeintightlyclosedoriginalcontainer.

Storeawayfromfood,drinkandanimalfeedingstuffs

Closethebagsecurelyafteruse.

Theshelflifeafterincorporationintofeedisthreemonths.

6.5 Natureandcompositionofimmediatepackaging

Three-plypapersackscontaining25kgofasoft,whiteoryellowishwhite

amorphouspowder.

Sacksarefilledviaasidevalve,whichistuckedinandgluedtoforma

closure.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts,if

appropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfrom

suchveterinarymedicinalproductsshouldbedisposedofinaccordance

withlocalrequirements.

Revised:May2013

AN:00905/2012

7. MARKETINGAUTHORISATIONHOLDER

DSMNutritionalProducts(UK)Limited

DelvesRoad

HeanorGateIndustrialEstate

Heanor

Derbyshire

DE757SG

8. MARKETINGAUTHORISATIONNUMBER

Vm19108/4000

9. DATEOFFIRSTAUTHORISATION

05May2000

10. DATEOFREVISIONOFTHETEXT

May2013

Approved: 17/05/2013

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Therapeutic Goods Administration - Australia

21-11-2018

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Active substance: Propagermanium) - Orphan designation - Commission Decision (2018)7810 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/103/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

22-10-2018

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Active substance: mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) - Centralised - Yearly update - Commission Decision (2018)6972 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

NexoBrid (MediWound Germany GmbH)

NexoBrid (MediWound Germany GmbH)

NexoBrid (Active substance: Concentrate of proteolytic enzymes enriched in bromelain) - PSUSA - Modification - Commission Decision (2018)6460 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10028/201712

Europe -DG Health and Food Safety

19-9-2018

Kadcyla (Roche Registration GmbH)

Kadcyla (Roche Registration GmbH)

Kadcyla (Active substance: Trastuzumab emtansine) - Centralised - Renewal - Commission Decision (2018)6100 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2389/R/39

Europe -DG Health and Food Safety

6-9-2018

 Trisenox (arsenic trioxide) supply shortage

Trisenox (arsenic trioxide) supply shortage

Europe - EMA - European Medicines Agency

23-8-2018

 Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Europe - EMA - European Medicines Agency

27-7-2018

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (Active substance: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA) - Transfer of orphan designation - Commission Decision (2018)5033 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/009/12/T/01

Europe -DG Health and Food Safety

27-6-2018

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Active substance: pantoprazole) - PSUSA - Modification - Commission Decision (2018)4105 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1100/PSUSA/2285/201708

Europe -DG Health and Food Safety

12-6-2018

EU/3/17/1956 (Sangamo Therapeutics UK LTD)

EU/3/17/1956 (Sangamo Therapeutics UK LTD)

EU/3/17/1956 (Active substance: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human iduronate 2-sulfatase gene) - Transfer of orphan designation - Commission Decision (2018)3811 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/168/17/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/17/1955 (Sangamo Therapeutics UK LTD)

EU/3/17/1955 (Sangamo Therapeutics UK LTD)

EU/3/17/1955 (Active substance: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human alpha L-iduronidase gene) - Transfer of orphan designation - Commission Decision (2018)3810 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/167/17/T/01

Europe -DG Health and Food Safety

6-6-2018

Agenda:  Agenda for the 100th meeting of the Management Board

Agenda: Agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

5-6-2018

Agenda:  Draft agenda for the 100th meeting of the Management Board

Agenda: Draft agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

24-5-2018

Tybost (Gilead Sciences International Limited)

Tybost (Gilead Sciences International Limited)

Tybost (Active substance: cobicistat) - PSUSA - Modification - Commission Decision (2018)3255 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10081/201708

Europe -DG Health and Food Safety

24-5-2018

Stribild (Gilead Sciences International Limited)

Stribild (Gilead Sciences International Limited)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - PSUSA - Modification - Commission Decision (2018)3277 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/PSUSA/10082/201708

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Active substance: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid) - Transfer of orphan designation - Commission Decision (2018)3149 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/14/T/01

Europe -DG Health and Food Safety

16-5-2018

Bravecto Plus (Intervet International B.V.)

Bravecto Plus (Intervet International B.V.)

Bravecto Plus (Active substance: fluralaner / moxidectin) - Centralised - Authorisation - Commission Decision (2018)3019 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4440

Europe -DG Health and Food Safety

3-5-2018

Trisenox (Teva B.V.)

Trisenox (Teva B.V.)

Trisenox (Active substance: Arsenic trioxide) - Centralised - Yearly update - Commission Decision (2018)2778 of Thu, 03 May 2018

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (Active substance: Adeno-associated viral vector serotype 9 encoding miRNA against human superoxide dismutase 1) - Orphan designation - Commission Decision (2018)2404 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/254/17

Europe -DG Health and Food Safety