Veteglan

Main information

  • Trade name:
  • Veteglan
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Veteglan
    Portugal
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • cloprostenol
  • Therapeutic area:
  • Cattle, Horses, Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • PT/V/0100/001
  • Authorization date:
  • 24-10-2007
  • EU code:
  • PT/V/0100/001
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Laboratorios Calier VETEGLAN0.075 mg/ml, Solutionforinjection

Part1B–SmPC, LabelandPackageInsert

PackageLeaflet

Theproposedwordingforthe package leafletto be included withthis medicinalproductis

includedon the followingpages.

Laboratorios Calier VETEGLAN0.075 mg/ml, Solutionforinjection

Part1B–SmPC, LabelandPackageInsert

PACKAGELEAFLET

VETEGLAN

0.075mg/ml Solution forinjection

d-Cloprostenol (sodiumsalt)

ForCows, sowsandmares

1. NAME ANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

ANDOFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLE

FOR BATCHRELEASE, IFDIFFERENT

Marketingauthorisation holderand manufacturer:

CALIERPORTUGAL,S.A.

CentroEmpresarialSintra-EstorilII,Edif.C

SINTRA

PORTUGAL

Manufacturer:

LABORATORIOSCALIER,S.A.

C/Barcelonès,26(PladeRamassà)

LESFRANQUESESDELVALLÈS,(Barcelona)SPAIN

KERNPHARMA S.L.

Pol. Ind. Colon II, c/Venus72

08228Terrasa

BarcelonaSPAIN

2. NAME OFTHEVETERINARYMEDICINALPRODUCT

VETEGLAN0.075 mg/mlSolutionforinjection forcows, sows and mares

3. STATEMENTOFTHEACTIVESUBSTANCE(S) ANDOTHERINGREDIENT(S)

Each mlcontains:

Active subtance

d-Cloprostenol......................................................................................0.075 mg

equivalentto d-Cloprostenolsodiumsalt……………...…………….… 0.079 mg

Excipient:

Chlorocresol...........................................................................................1.000 mg

Excipients q.f……………………………………………..……………1.000 ml

Laboratorios Calier VETEGLAN0.075 mg/ml, Solutionforinjection

Part1B–SmPC, LabelandPackageInsert

4. INDICATION(S)

Cows

Induction andsynchronisation ofoestrus

Induction ofparturition

Ovariandysfunctionduetopersistentcorpusluteum:postpartumanoestrus,silentheat,

irregularandanovulatorycycles, persistentcorpusluteum, lutealcysts;

Pyometra, endometritis;

Interruption ofpregnancy(firststage ofgestation)includingfoetalmummification;

Post-puerperiumuterine dysfunctions, delayed uterineinvolution;

Therapyassociatedtothetreatmentoffollicularcysts(10-14daysafteradministrationof

GnRHorhCG)

Sows

Induction ofparturition

Mares

Induction ofparturition

Induction ofoestrus

5. CONTRAINDICATIONS

Donotuseinpregnantanimalsunlessitisdesirabletoinduceparturitionorinterruptionof

pregnancyandtoanimalswithspasticdysfunctionsofthegastrointestinaltract/orrespiratory

system.

Do notuse in caseofhypersensitivityto the active substanceortoanyofthe excipients

6. ADVERSEREACTIONS

Occurrenceofanaerobicinfectionislikelyifanaerobicbacteriapenetratethetissueoftheinjection

site.Thisappliesespeciallytointramuscularinjectionandinparticulartocows.Typicallocal

reactionsduetoanaerobicinfectionareswellingandcrepitusattheinjectionsite. Whenusedfor

inductionofparturitionanddependingonthemomentoftreatmentrelativetothedateof

conception, increase ofplacentalretentionratecan occur.

Ifyou notice anyserious effects orothereffects notmentionedinthis leaflet, pleaseinformyour

veterinarysurgeon

7. TARGETSPECIES

Bovines(cows), porcines (sows)andequines (mares).

8. DOSAGEFOR EACHSPECIES, ROUTE(S) ANDMETHODOF

ADMINISTRATION

VETEGLANshouldbeonlyadministeredbyintramuscularroute.

Cows:2 mlVETEGLAN/animal(150 µgp.a. /animal)

Inductionofoestrus(alsoincowsshowingweakorsilentheat):AdministerVETEGLANafter

determination ofthe presenceofa functionalcorpusluteum(6 th

to 18 th

dayofcycle). Heatusually

Laboratorios Calier VETEGLAN0.075 mg/ml, Solutionforinjection

Part1B–SmPC, LabelandPackageInsert

appearswithin48-60hours.Proceedtoinsemination72-96haftertreatment.Ifthereisnosign

ofoestrus,thetreatmentmaybe repeated11 days afterthefirstinjection.

Inductionofparturition:administerVETEGLANafterthe270 th dayofgestation.Parturition

usuallytakesplace within30-60 hours aftertreatment.

Synchronisationofoestrus:administerVETEGLANtwice(withinanintervalof11days).

Proceed with inseminations72h and96 h afterthesecond injection.

Ovariandysfunction:administerVETEGLANafterdeterminationofpresenceofthecorpus

luteum.Then,proceedtoinseminateatthefirstoestrusafterinjection.Ifoestrusdoesnottake

place,conductafurthergynaecologicalexamination,andrepeattheinjection11daysafterthe

firstadministration. Insemination mustalways becarried out72-96 hours afterinjection.

Endometritis,pyometra:administeronedoseofVETEGLAN.Ifnecessary,repeatthetreatment

after10 days.

Mummifiedfoetus:AdministeronedoseofVETEGLAN.Expulsionofthefoetusisobserved

within 3-4 days afteradministration oftheproduct.

Interruption ofpregnancy:administerVETEGLANinthefirsthalfofpregnancy.

Post-puerperiumuterinedysfunctions:administer1mlofVETEGLANand,ifnecessary,carry

outone ortwo furthertreatments (withinan intervalof24 hours).

Therapyassociatedtothetreatmentoffollicularcysts:administerVETEGLAN10-14daysafter

verifyingthe positive responseto treatmentwith GnRHorHCG.

Sows:1mlVETEGLAN/animal(75µgp.a./animal)

Inductionoffarrowing:AdministerVETEGLANfromthe112 th dayofpregnancy.Inaround70%of

theanimals,parturitionoccurs19-30hoursaftertreatment.

Mares:1mlVETEGLAN/animal(75µgp.a./ml)

Inductionofoestrus:administerVETEGLANpreferablyafterverifyingthepresenceofacorpus

luteum.

Inductionofparturition:administerVETEGLANfromthe320 th dayofgestation,mostanimalsare

expectedtorespondwithinfewhoursfollowinginjection.

9. ADVICEONCORRECTADMINISTRATION

Specialprecautionsforusein animals:

Injectionincontaminatedskinareasshouldbeavoided.Theinjectionsitemustbethoroughly

cleaned and disinfected before administrationofthe product.

Specialprecautionsto be taken bytheperson administeringtheproductto animals:

VETEGLANcan be absorbed through theskin. Avoidmucousmembranecontactorinhalation.

In caseofcontactwithskin, rinseimmediatelywith waterand soap.

PFG2 

cancausebronchospamsinhumans.Incaseofrespiratorydisturbancesduetoinhalation

oraccidentalinjection, seekmedicaladvice immediately

Pregnantwomen should handlethe productwithextreme precaution

Laboratorios Calier VETEGLAN0.075 mg/ml, Solutionforinjection

Part1B–SmPC, LabelandPackageInsert

10. WITHDRAWALPERIOD

Bovines:meat:0day;milk:0day

Porcines:meat:1day

Equines:donotadministertohorseswhosemeatisintendedforhumanconsumption

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren

Donotstoreabove25ºC

Do notuse afterthe expirydatestated onthe carton and the vial

Shelf-life afterfirstopeningthe container:28 days

12. SPECIALWARNING(S)

Donotadministertohorseswhosemeatisintendedforhumanconsumption

Do notadministerto pregnantanimals unlessitis desirable toinduce parturition orinterruption of

pregnancy.

Donotadministerthetreatmenttogetherwithnon-steroidalanti-inflammatorydrugssincethey

inhibitendogenous prostaglandinsynthesis.

13. SPECIALPRECAUTIONS FORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS, IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchmedicinal

productsshould bedisposed ofin accordance with advicefromlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWAS LASTAPPROVED

September/2007

15. OTHERINFORMATION

Notallpacksizesmaybe marketed

12-12-2018

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Moonstruck Chocolate Company of Portland, Oregon is recalling 600/4 oz. bags of Sea Salt Caramels Tumbled In Milk Chocolate, because it may contain undeclared hazelnuts. People who have an allergy or severe sensitivity to hazelnuts run the risk of a serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

7-12-2018

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Published on: Thu, 06 Dec 2018 The present scientific opinion deals with the assessment of the bioavailability of magnesium, from the proposed nutrient source, magnesium citrate malate (MgCM), when added for nutritional purposes to food supplements. MgCM is a mixed salt consisting of magnesium cations and citrate and malate anions, and with a magnesium content of 12–15%. MgCM is proposed to be used in food supplements that are intended to provide up to 300–540 mg/day magnesium. The data provided demonst...

Europe - EFSA - European Food Safety Authority Publications

1-12-2018

Tres Hermanos Bakery Issues Allergy Alert on Undeclared Milk in Telera and Bolillo Breads

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Tres Hermanos Bakery of Wyoming, MI is recalling its white Telera and Bolillo Mexican salt breads because they may contain undeclared milk. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

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Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

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Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Pest categorisation of Popillia japonica

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Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

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Europe - EFSA - European Food Safety Authority Publications

9-11-2018

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Europe - EFSA - European Food Safety Authority Publications

5-11-2018

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France - Agence Nationale du Médicament Vétérinaire

2-11-2018

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FDA - U.S. Food and Drug Administration

2-11-2018

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FDA - U.S. Food and Drug Administration

29-10-2018

Maribel’s Sweets Inc. Allergy Alert on Undeclared Milk Allergens in Chocolate Bars

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FDA - U.S. Food and Drug Administration

10-10-2018

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FDA - U.S. Food and Drug Administration

9-10-2018

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Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

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Europe - EFSA - European Food Safety Authority Publications

8-9-2018

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FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

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FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

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FDA - U.S. Food and Drug Administration

31-8-2018

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

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FDA - U.S. Food and Drug Administration

29-8-2018

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

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FDA - U.S. Food and Drug Administration

22-8-2018

King Bio Issues Voluntary Nationwide Recall of It’s Kids and Infant Products Due to Potential Microbial Contamination

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FDA - U.S. Food and Drug Administration

15-8-2018

Salt & Straw Voluntarily Recalls Certain Lots of Chocolate Gooey Brownie Ice Cream Pints Due to Possible Undeclared Peanuts

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FDA - U.S. Food and Drug Administration

8-8-2018

Enforcement Report for the Week of August 08, 2018

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FDA - U.S. Food and Drug Administration

31-7-2018

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

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FDA - U.S. Food and Drug Administration

18-7-2018

Sodium glucose co-transporter 2 inhibitors

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Therapeutic Goods Administration - Australia

28-11-2018

PHEBURANE (Eurocept International BV)

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Europe -DG Health and Food Safety

21-11-2018

EU/3/08/556 (Vertex Pharmaceuticals (Ireland) Limited)

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Europe -DG Health and Food Safety

8-10-2018

Palonosetron Hospira (Pfizer Europe MA EEIG)

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Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

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Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

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Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan Pharma (Mylan S.A.S.)

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Pregabalin Mylan Pharma (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 6097 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3962/T/08

Europe -DG Health and Food Safety

7-9-2018

 European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency, London, UK, From: 08-Jun-2018, To: 08-Jun-2018

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Europe - EMA - European Medicines Agency

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

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Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

8-8-2018

GONAL-f (Merck Europe B.V.)

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GONAL-f (Active substance: Follitropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5445 of Wed, 08 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/71/T/140

Europe -DG Health and Food Safety

3-8-2018

Sodium oxybate

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Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

Europe -DG Health and Food Safety

11-7-2018

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Active substance: Alendronate Sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4518 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/619/T/42

Europe -DG Health and Food Safety

10-7-2018

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Active substance: Alendronate sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4477 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/759/T/39

Europe -DG Health and Food Safety

10-7-2018

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Active substance: Sodium phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)4483 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Withdrawn application:  Prohippur, sodium benzoate, Initial authorisation

Withdrawn application: Prohippur, sodium benzoate, Initial authorisation

Europe - EMA - European Medicines Agency

19-6-2018

Xyrem (UCB Pharma S.A.)

Xyrem (UCB Pharma S.A.)

Xyrem (Active substance: Sodium oxybate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3912 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/593/T/74

Europe -DG Health and Food Safety