DOLAGIS dogs tablet 50 mg

Main information

  • Trade name:
  • DOLAGIS dogs tablet 50 mg
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DOLAGIS dogs tablet 50 mg
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • carprofen
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0172/001
  • Authorization date:
  • 06-01-2010
  • EU code:
  • FR/V/0172/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

VeterinaryMedicinalProduct

DOLAGIS50mgtabletsfordogs

PARTIB

SUMMARYOFPRODUCTCHARACTERISTICS

PharmaceuticalForm

Tablet

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

DOLAGIS50mgtabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Onetabletcontains:

Carprofen...................................................................50mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Clover-shapedscoredbeigetablet

Thetabletcanbedividedintofourequalparts.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Inthedog:

Reductionofinflammationandpaincausedbymusculo-skeletaldisordersanddegenerative

jointdisease.

Asafollow-uptoparenteralanalgesiainthemanagementofpost-operativepain.

4.3 Contraindications

Donotuseinpregnantandlactatingbitches.

Donotuseindogsagedlessthan4monthsintheabsenceofspecificdata.

Donotuseincats.

Donotuseindogs,sufferingfromcardiac,hepaticorrenaldisease,whenthereisa

possibilityofgastrointestinalulcerationorbleedingorwherethereisevidenceofblood

dyscrasia.

Donotuseincaseofhypersensitivitytotheactivesubstance,tootherNSAIDsandtoanyof

theexcipients.

4.4Specialwarningsforeachtargetspecies

Seesections4.3and4.5.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Useindogslessthan6weeksofage,orinageddogs,mayinvolveadditionalrisk.Ifsucha

usecannotbeavoided,dogsmayrequireareduceddosageandcarefulclinical

management.

Avoiduseinanydehydrated,hypovolaemicorhypotensivedog,asthereisapotentialriskof

increasedrenaltoxicity.

Concurrentadministrationofpotentialnephrotoxicdrugsshouldbeavoided.

NSAIDscancauseinhibitionofphagocytosisandhenceinthetreatmentofinflammatory

conditionsassociatedwithbacterialinfection,appropriateconcurrentantimicrobialtherapy

shouldbeinstigated.

AswithotherNSAIDs,photodermatitisduringtreatmentwithcarprofenhasbeenobservedin

laboratoryanimalsandinhumans.Theseskinreactionshaveneverbeenobservedindogs.

DonotadministerotherNSAIDsconcurrentlyorwithin24hoursofeachother.Some

NSAIDsmaybehighlyboundtoplasmaproteinsandcompetewithotherhighlybounddrugs,

whichcanleadtotoxiceffects.

Duetothegoodpalatabilityofthetablet,theyshouldbestoredinasafeplaceoutofthe

reachofanimals.Intakeofdoseexceedingtherecommendednumberoftabletsmayleadto

severeadverseeffects.Ifthisisthecase,seekveterinaryassistanceimmediately.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthepackage

leaflettothephysician.

Washhandsafterhandlingtheproduct.

4.6Adversereactions(frequencyandseriousness)

TypicalundesirableeffectsassociatedwithNSAIDs,suchasvomiting,softfaeces/diarrhea,

faecaloccultblood,lossofappetiteandlethargyhavebeenreported.Theseadverse

reactionsgenerallyoccurwithinthefirsttreatmentweekandareinmostcasestransientand

disappearfollowingterminationofthetreatmentbutinveryrarecasesmaybeseriousor

fatal.

Ifadversereactionsoccur,useoftheproductshouldbestoppedandtheadviceofa

veterinarianshouldbesought.

AswithotherNSAIDsthereisariskofrarerenaloridiosyncratichepaticadverseevents.

4.7Useduringpregnancyandlactation

Studiesinlaboratoryspecies(ratandrabbit)haveshownevidenceoffoetotoxiceffectsof

carprofenatdosesclosetothetherapeuticdose.Thesafetyoftheveterinarymedicinal

producthasnotbeenestablishedduringpregnancyandlactation.Donotuseinpregnantor

lactatingbitches.

Forbreedinganimals,donotuseduringreproductionperiod.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Carprofenishighlyboundtoplasmaproteinsandcompetewithotherhighlybounddrugs,

whichcanincreasetheirrespectivetoxiceffects.

DonotusethisveterinarymedicinaldrugconcurrentlywithotherNSAIDsorwith

glucocorticoids.

Concurrentadministrationofpotentiallynephrotoxicdrugs(e.g.aminogylcosideantibiotics)

shouldbeavoided.

Refersalsotosection4.5

4.9 Amountstobeadministeredandadministrationroute

Fororaladministration.

4mgcarprofenperkgbodyweightperday.

Aninitialdoseof4mgcarprofenperkgbodyweightperdaygivenasasingledailydose.The

analgesiceffectfromeachdosepersistsforatleast12hours.

Thedailydosemaybereduced,subjecttoclinicalresponse.

Durationoftreatmentwillbedependantupontheresponseseen.Longtermtreatmentshould

beunderregularveterinarysupervision.

Toextendanalgesicandanti-inflammatorycoverpost-operativelyparenteralpre-operative

treatmentwithaninjectablecarprofenmaybefollowedwithcarprofentabletsat4mg/kg/dayfor

5days.

Donotexceedthestateddose.

Thebreakabilitymethodisthefollowing:Putthetabletonaplainsurface,withitsscoredside

facingthesurface(convexfaceup).

Withthetipofforefinger,exertaslightverticalpressureonthemiddleofthetablettobreakit

initswidthintohalves.Inordertoobtainquarters,thenexertaslightpressureonthemiddle

ofonehalfwithforefingertobreakitinitslength.

Thetabletisdivisibleandcanbeusedasfollows:

Numberoftabletsperday Dogweight(kg)

¼ >3 - <6

½ ≥6 - <9

¾ ≥9 - <12.5

1 ≥12.5 - <15.5

1¼ ≥15.5 - <18.5

1½ ≥18.5 - <21.5

1¾ ≥21.5 - <25

2 ≥25 - <28

2¼ ≥28 - <31

2½ ≥31 - <34

2¾ ≥34 - <37

3 ≥37 - <40

3¼ ≥40 - <43

3½ ≥43 - <45

Thetabletsareflavoured,andareacceptedbydogs,buttheymaybeadministereddirectly

inthemouthofthedogoraddedtofoodifnecessary.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Bibliographicdatareportthatcarprofeniswelltoleratedindogsattwicetherecommended

dosagefor42days.

Dosesupto3timestherecommendeddosearereportedtobewithoutadverseeffects.

Thereisnospecificantidotetocarprofenbutgeneralsupportivetherapyasappliedtoclinical

overdosewithNSAIDsshouldbeapplied.

4.11 Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

ATCvetcode:QM01AE91

Pharmacotherapeuticgroup:Anti-inflammatoryandanti-rheumaticproducts,nonsteroidal,

propionicacidderivatives

5.1Pharmacodynamicproperties

Carprofenisanon-steroidalanti-inflammatorydrug(NSAID),ofthe2-arylpropionicacid

classandpossessesanti-inflammatory,analgesicandantipyreticactivities.

Themechanismofactionofcarprofen,isnotwellknown.However,itwasshownthatthe

inhibitionofthecyclo-oxygenaseenzymebycarprofenisrelativelyweakatthe

recommandeddosage.Moreover,itwasshownthatcarprofendoesn’tinhibitthegeneration

ofthromboxane(TX)B2indogclottingbloodandneitherprostaglandin(PG)E2nor12-

hydroxyeicosatetraenoicacid(HETE)ininflammatoryexudateareinhibited.Thissuggests

themechanismofactionofcarprofenisnottheinhibitionoftheeicosanoids.Someauthors

suggestedanactivityofcarprofenononeornumerousinflammatoymediatorsnotyet

identifiedbutnoclinicalevidencecouldbeshown.

Carprofenexistsintwoenantiomericforms,R(-)-carprofenandS(+)-carprofenandthe

racemicformistheonemarketed.LaboratoryanimalstudiessuggestthattheS(+)

enantiomerpossessesgreateranti-inflammatorypotency.

Ulcerogenicpotentialofcarprofenhasbeenshownintherodentsbutnotinthedogs.

5.2 Pharmacokineticparticulars

Afterasingleoraladministrationof4mgofcarprofenperkgofbodyweightindog,thetime

toobtainamaximumplasmaticconcentrationof23µg/mlisabout2hours.Theoral

bioavailabilityismorethan90%ofthetotaldose.Carprofenismorethan98%boundto

plasmaproteinsanditsvolumeofdistributionislow.

Carprofenisexcretedinthebilewith70%ofanintra-venousdoseofcarprofenbeing

eliminatedinthefaeces,mainlyastheglucuronideconjugate.Carprofenundergoesan

enantioselectiveenterohepaticcycleindog,withonlytheS(+)enantiomerbeingsignificantly

recycled.TheplasmaticclearanceoftheS(+)carprofenisabouttwicethatoftheR(-)

carprofen.ThebiliaryclearanceofS(+)carprofenseemstobesubjecttostereoselectivitytoo

asitisaboutthreetimeshigherthanthatofR(-)carprofen.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Pigliverflavour

Yeast,

Croscarmellosesodium,

Copovidone,

Magnesiumstearate,

Anhydrouscolloidalsilica,

Microcrystallinecellulose,

Lactosemonohydrate.

6.2Incompatibilities

None

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:72hours

6.4.Specialprecautionsforstorage

Donotstoreabove30°C.

Protectfromlight

Dividedtabletsshouldbestoredintheblisterpack.Anydividedtabletportionsremaining

after72hoursshouldbediscarded.

6.5Natureandcompositionofimmediatepackaging

Blistercomplex:PVDC-PVC/Aluminiumheatsealedblisterswith10tablets/blister.

Cardboardboxwith2blistersof10tablets

Cardboardboxwith10blistersof10tablets

Cardboardboxwith20blistersof10tablets

Cardboardboxwith30blistersof10tablets

Cardboardboxwith40blistersof10tablets

Cardboardboxwith50blistersof10tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

LaboratoiresSOGEVAL

200AvenuedeMayenne-BP2227-

53022LAVALCEDEX9

FRANCE

Tel:33243495151

Fax:33243539700

E-mail:sogeval@sogeval.fr

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10. DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Tobecompletedinaccordancewithnationalrequirements

11-12-2018

THAN YOU tablets

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THAN YOU tablets pose a serious risk to your health and should not be taken.

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30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

29-10-2018

Big Penis U.S.A tablets

Big Penis U.S.A tablets

Big Penis U.S.A tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

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

8-10-2018

Glyceryl trinitrate tablets (Anginine and Lycinate)

Glyceryl trinitrate tablets (Anginine and Lycinate)

Update 3 - continuing medicine shortage

Therapeutic Goods Administration - Australia

28-9-2018

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see pic...

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

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

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

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

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

FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles

FDA - U.S. Food and Drug Administration

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

22-8-2018

Germany Niubian tablets

Germany Niubian tablets

Germany Niubian tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

22-8-2018

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industr...

FDA - U.S. Food and Drug Administration

18-8-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

FDA - U.S. Food and Drug Administration

15-8-2018

G Female Oral Tablets

G Female Oral Tablets

G Female Oral Tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

9-8-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

3-8-2018

Scientific guideline:  Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

3-8-2018

Scientific guideline:  Agomelatine tablet 25 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Agomelatine tablet 25 mg product-specific bioequivalence guidance, adopted

Agomelatine tablet 25 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

25-7-2018

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., is recalling dry whey powder packaged in 50-pound and 25-kg bags that were produced at the cooperative’s Blair, Wis., dry whey plant from May 1-5, 2018; May 24-29, 2018; June 2-5, 2018; and June 7-14, 2018 due to the potential to be contaminated with Salmonella. This is a precautionary recall. All products shipped to the marketplace tested negative for Salmonella.

FDA - U.S. Food and Drug Administration

24-7-2018

FDA Advises Vets of Percorten™-V Shortage and Alternative Drug Option for Treatment of Canine Addison’s Disease

FDA Advises Vets of Percorten™-V Shortage and Alternative Drug Option for Treatment of Canine Addison’s Disease

FDA is aware of a shortage of Percorten™-V (desoxycorticosterone pivalate injectable suspension), which is approved for use as replacement therapy for mineralocorticoid deficit in dogs with primary adrenocortical insufficiency, more commonly known as Addison’s Disease.

FDA - U.S. Food and Drug Administration

23-7-2018

FDA Awards Grants to Fund Studies for Drugs for Minor Uses/Minor Species

FDA Awards Grants to Fund Studies for Drugs for Minor Uses/Minor Species

FDA has awarded five grants totaling $650,000 to provide funding for studies to support the approval or conditional approval of three different products, including a cancer drug for dogs.

FDA - U.S. Food and Drug Administration

18-7-2018

FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs

FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs

FDA has approved NexGard (afoxolaner), a chewable tablet administered once monthly to dogs, for the prevention of Borrelia burgdorferi (B. burgdorferi) infections by killing Black-legged ticks (Ixodes scapularis), which carry the bacterium.

FDA - U.S. Food and Drug Administration

17-7-2018

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

FDA - U.S. Food and Drug Administration

17-7-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking wat...

FDA - U.S. Food and Drug Administration

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

12-7-2018

FDA Investigating Potential Connection Between Diet and Cases of Canine Heart Disease

FDA Investigating Potential Connection Between Diet and Cases of Canine Heart Disease

FDA is alerting pet owners and veterinary professionals about reports of canine dilated cardiomyopathy (DCM) in dogs eating certain pet foods containing peas, lentils, other legume seeds, or potatoes as main ingredients.

FDA - U.S. Food and Drug Administration

29-6-2018

UPDATE: FDA Animal Drug Safety Communication: FDA continues to warn about risk of accidental overdosing of dogs with the noise aversion drug Sileo

UPDATE: FDA Animal Drug Safety Communication: FDA continues to warn about risk of accidental overdosing of dogs with the noise aversion drug Sileo

FDA is alerting dog owners and veterinarians about the risk of accidental overdose to dogs treated with the drug Sileo, a prescription gel that is given to dogs by mouth to treat noise aversion.

FDA - U.S. Food and Drug Administration

28-6-2018

Need for Seal tablets

Need for Seal tablets

Need for Seal tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

19-9-2018

Targretin (Eisai GmbH)

Targretin (Eisai GmbH)

Targretin (Active substance: bexarotene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6098 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/326/T/50

Europe -DG Health and Food Safety