ALTRESYN 4 mg/ml oral solution

Main information

  • Trade name:
  • ALTRESYN 4 mg/ml oral solution
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ALTRESYN 4 mg/ml oral solution
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Altrenogest
  • Therapeutic area:
  • Pigs Females

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0198/001
  • Authorization date:
  • 23-02-2012
  • EU code:
  • FR/V/0198/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ALTRESYN4mg/mloralsolution

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlcontains:

Activesubstance:

Altrenogest...........................................................................................4.00mg

Excipients:

Butylhydroxyanisole(E320)...................................................................0.07mg

Butylhydroxytoluène(E321)..................................................................0.07mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Oralsolution.

Clear,paleyellow,odourlesssolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigs(sexuallymaturegilts).

4.2 Indicationsforuse,specifyingthetargetspecies

Forthesynchronisationofoestrusinsexuallymaturegilts.

4.3 Contra-indications

Donotadministertoanimalssufferingfromuterineinfection.

Donotadministertomaleanimals.

Seesection4.7.

4.4 Specialwarningsforeachtargetspecies

None.

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4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Addtheveterinarymedicinalproducttothefeedimmediatelybeforefeeding.Discardanyuneaten

medicatedfeed

Touseonlyinsexuallymaturegiltswhohadalreadypresentedoneoestrus.

Partconsumedfeedmustbesafelydisposedofandnotgiventoanyotheranimal.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Directcontactwiththeskinshouldbeavoided.Personalprotectiveclothing(glovesandoveralls)mustbe

wornwhenhandlingtheproduct.

Porousglovesmayletthisproductpassthroughtotheskin.Iftheproductmakescontactwiththeskin

underneaththeglove,occlusivematerialssuchaslatexorrubberinglovesmayenhancetranscutaneous

absorptionoftheproduct.

Accidentalspillageontheskinoreyesshouldbewashedoffimmediatelywithplentyofwater.

Washhandsaftertreatmentandbeforemeals.

Pregnantwomenandwomenofchildbearingageshouldavoidcontactwiththeproductorshouldexercise

extremecautionwhenhandlingthisproduct.

Peoplesufferingfromprogesteronedependenttumours(knownorsuspected)orfromthromboembolic

disordersshouldnotusetheproduct.

Over-exposureeffects:Accidentalabsorptioncouldleadtodisruptionofthemenstrualcycle,uterineor

abdominalcramping,increasedordecreaseduterinebleeding,prolongationofpregnancyorheadache.

Directcontactwiththeskinshouldthereforebeavoided.

Incaseofover-exposure,seekmedicaladvice.

4.6 Adversereactions(frequencyandseriousness)

Ensurethecorrectdoseisadministereddailyasunder-dosingcanleadtotheformationofcysticfollicles.

4.7 Useduringpregnancy,lactationorlay

Donotuseinpregnantorlactatinganimals.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Fororaluseasatop-dressing.

20mgaltrenogest/animal,i.e.5mlperanimalonceadayfor18consecutivedays.

For540and1080mlpresentations:

TheproductshouldbeadministeredwiththeAltresyndoseronly.

Toprimethedoser:

- putthebottleinanhorizontalposition,thenozzleofthedoserdirectedup-wards

- slowlypressthetriggeruntiladroppearlsatthetipofthenozzle.

Then,thedoserdelivers5mldoseforeachcompleteactivationofthetrigger.Fortheregularadministration

holdthevialverticallyupside-down.Thedosershouldremainonthebottleforthewholeproductin-use

period,andthelocksystemshouldbeusedforanystoragebetweentreatments.

Forthe360mlpresentation:

Pressandreleasethemeteringpumptodeliverone5mldose.Donotshakebeforeusetoavoidmixingthe

solutionwiththenitrogenincludedinthepressurisedcontainer.

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Animalsshouldbesegregatedanddosedindividually.Addtheproductasatopdressingtothefeed.Addto

thesurfaceofthefeedimmediatelybeforefeeding.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noneknown.

4.11Withdrawalperiods

Meatandoffal:9days.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Sexhormonesandmodulatorsofthegenitalsystem.

ATCvetcode:QG03DX90.

5.1 Pharmacodynamicproperties

Altrenogestisasyntheticprogestagenbelongingtothe19-nor-testosteronefamily.Thisprogestagenis

activebyoralroute.Altrenogestactsbydecreasingplasmaconcentrationsofendogenousgonadotrophin

hormones(LHandFSH).Lowgonadotrophinconcentrationsinducetheregressionoflargefollicles

(>5mm)anddonotallowthegrowthoffolliclesgreaterthan3mm,leadingthentoanabsenceofœstrus

andovulationduringtreatment.TheendoftreatmentisfollowedbyaregularincreaseinLHplasma

concentrationallowingfolliculargrowthandmaturation.Then,animalsreturntoheatinasynchronisedway.

5.2 Pharmacokineticparticulars

Altrenogestisrapidlyabsorbedfollowingoraladministration,withpeakplasmaconcentrationsbeing

reachedbetween1and4hoursaftertreatment.Altrenogestismainlymetabolisedintheliverandeliminated

bybiliaryexcretion.Halflifeofeliminationisestimatedtobearound14hours.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Butylhydroxyanisole(E320)

Butylhydroxytoluène(E321)

Soyabeanoil

Nitrogen

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelf-lifeafterfirstopeningtheimmediatepackaging(for540and1080mlpresentations):2months.

4/4 Dokument1

6.4.Specialprecautionsforstorage

360mlpressurizedcontainer:Protectfromsunlightanddonotexposetotemperaturesexceeding50°C.Do

notpierceorburn,evenafteruse.

540and1080ml:nospecialprecautionsforstorage.

6.5 Natureandcompositionofimmediatepackaging

Natureof360mlcontainer:

"Pressurisedaluminiumcontainerwithameteringpump."

Natureof540and1080mlcontainers:

Aluminiumcontainerclosedwithapolyethyleneplugandapolypropylenescrewcap.

Packagesize:

Cartonof1containerof360ml

Cartonof3containersof360ml

540mlcontainer

1080mlcontainer

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwastematerials

derivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproducts

shouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

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Philippe Reignault appointed Director of the Plant Health Laboratory and Director of Plant Health at ANSES

Philippe Reignault appointed Director of the Plant Health Laboratory and Director of Plant Health at ANSES

On 4 June, Philippe Reignault was appointed Director of the ANSES Plant Health Laboratory and will also take over from Charles Manceau as Director of Plant Health, with effect from July. Professor of Plant Biology and Diseases at the Littoral Côte d'Opale University since 2010 and Chair of ANSES's Expert Committee on Plant Health since 2012, he will now be responsible for overall coordination of ANSES's scientific work in plant health and protection.

France - Agence Nationale du Médicament Vétérinaire

31-5-2018

LFIT Anatomic CoCr V40 Femoral Heads

LFIT Anatomic CoCr V40 Femoral Heads

Hazard alert - potential for components to separate

Therapeutic Goods Administration - Australia

29-5-2018

TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out of Sequence Capsules

TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out of Sequence Capsules

Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules. As a result of this packaging error, oral contraceptive capsules, that are taken out of sequence, may place the user at risk for contraceptive failure and unintended pregnancy. The reversing of the order may not be apparent to either new users or previous ...

FDA - U.S. Food and Drug Administration

26-5-2018

Shadow Holdings, LLC Issues Voluntary Nationwide Recall of X-Jow and Acne Shave products due to Possible Bacterial Contamination

Shadow Holdings, LLC Issues Voluntary Nationwide Recall of X-Jow and Acne Shave products due to Possible Bacterial Contamination

Shadow Holdings is voluntarily recalling all lots, within expiry, of Herb-X Solutions X-Jow Pain Gel, and United Exchange Acne Shave Moisturizer, Acne Shave Shave Cream with Acne Shield, and Acne Shave Shave Kit to the retail level. The products may be contaminated with bacteria.

FDA - U.S. Food and Drug Administration

25-5-2018

Link Product Solutions Limited recalls Summer Time TM Puffer Balls

Link Product Solutions Limited recalls Summer Time TM Puffer Balls

These toys do not meet the Canadian safety requirements for toys. Some of the soft, stretchy parts of the toys can stretch to extreme lengths, posing a strangulation hazard to children.

Health Canada

24-5-2018

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

The FDA has approved Semintra (telmisartan oral solution), the first FDA-approved animal drug to control systemic hypertension in cats. Semintra is an oral solution administered either directly into the cat’s mouth or on top of a small amount of food.

FDA - U.S. Food and Drug Administration

23-5-2018

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit

OTC oral health products containing benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed. FDA is asking companies to stop selling these products for such use and requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.

FDA - U.S. Food and Drug Administration

23-5-2018

Oral Over-the-Counter Benzocaine Products: Drug Safety Communication  - Risk of Serious and Potentially Fatal Blood Disorder

Oral Over-the-Counter Benzocaine Products: Drug Safety Communication - Risk of Serious and Potentially Fatal Blood Disorder

Oral over-the-counter benzocaine products should not be used to treat infants and children younger than 2 years and should only be used in adults and children 2 years and older if they contain certain warnings on the drug label.

FDA - U.S. Food and Drug Administration

22-5-2018

Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics

Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics

FDA is taking safety actions regarding over-the-counter benzocaine oral drug products and prescription local anesthetics.

FDA - U.S. Food and Drug Administration

19-4-2018

Certain Kratom-Containing Powder Products by Viable Solutions: Recall -Possible Salmonella Contamination

Certain Kratom-Containing Powder Products by Viable Solutions: Recall -Possible Salmonella Contamination

Viable Solutions of Nampa, ID has initiated a recall of certain Kratom-containing powder products, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result...

FDA - U.S. Food and Drug Administration

20-3-2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

First-generation oral sedating antihistamines – use in children, Suvorexant (Belsomra) – next day effects, Desvenlafaxine (Pristiq) recommended dose, Miconazole and potential interaction with warfarin

Therapeutic Goods Administration - Australia

21-8-2018

Always use contact lens solution, not water, to clean and store your lenses!  #OnePairTakeCare  https://go.usa.gov/xUs89 pic.twitter.com/Jm50z0UFVu

Always use contact lens solution, not water, to clean and store your lenses! #OnePairTakeCare https://go.usa.gov/xUs89 pic.twitter.com/Jm50z0UFVu

Always use contact lens solution, not water, to clean and store your lenses! #OnePairTakeCare https://go.usa.gov/xUs89  pic.twitter.com/Jm50z0UFVu

FDA - U.S. Food and Drug Administration

27-7-2018

EU/3/09/645 (Camurus AB)

EU/3/09/645 (Camurus AB)

EU/3/09/645 (Active substance: Octreotide chloride (lipid depot solution)) - Transfer of orphan designation - Commission Decision (2018)5047 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/09/T/03

Europe -DG Health and Food Safety

19-7-2018

HES (hydroxyethyl starch)

HES (hydroxyethyl starch)

HES (hydroxyethyl starch) (Active substance: hydroxyethyl starch (HES), solutions for infusion) - Community Referrals - Art 107i - Commission Decision (2018)4832 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-107i/1457

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

29-5-2018

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Active substance: Ambroxol hydrochloride) - Orphan designation - Commission Decision (2018)3384 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/236/17

Europe -DG Health and Food Safety

29-5-2018

EU/3/09/645 (Novartis Europharm Limited)

EU/3/09/645 (Novartis Europharm Limited)

EU/3/09/645 (Active substance: Octreotide chloride (lipid depot solution)) - Transfer of orphan designation - Commission Decision (2018)3397 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/09/T/02

Europe -DG Health and Food Safety

2-5-2018

Agenda:  Agenda - Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) Joint Big Data Task Force meeting: identifying solutions for big data challenges

Agenda: Agenda - Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) Joint Big Data Task Force meeting: identifying solutions for big data challenges

Big data workshop: regulatory solutions for big data challenges

Europe - EMA - European Medicines Agency