Friday 2 September 2016

Bimectin Paste




Generic Name: ivermectin paste

Dosage Form: FOR ANIMAL USE ONLY

INDICATIONS:  Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.  Bimectin (ivermectin) Paste provides effective treatment and control of the following parasites in horses.  Large Strongyles (adults)- Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus and Craterostomum acuticaudatum; Small Strongyles(adults, including those resistant to some benzimidazole class compounds)- Coronocyclus spp. including C. coronatus, C. labiatus and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp.; Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus and Petrovinema poculatum; Small Strongyles - Fourth-stage larvae; Pinworms (adults and fourth-stage larvae)- Oxyuris equi, Ascarids (adults, third-stage and fourth-stage larvae)- Parascaris equorum; Hairworms (adults)- Trichostrogylus acei, Large-mouth Stomach Worms (adults)- Habronema muscae, Bots (oral and gastric stages)- Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults ad fourth-stage larvae)- Dictyocaulus arnfieldi, Intestinal Threadworms(adults)- Strongyloids westeri, Summer Sorescaused by Habronema and Draschia spp.  cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.



DOSAGE AND ADMINISTRATION:  This syringe contains sufficient paste to treat one 1250 lb horse at the recommended dose rate of 91mcg invermectin per lb (200 mcg/kg) body weight.  Each weight marking on the syringe plunger delivers enough paste to treat 250 lb body weight.


(1)  While holding plunger, turn knurled ring on the plunger 1/4 turn to the left and slide it so the side nearest the barrel is at the prescribed weight marking.  (2)  Lock the ring in place by making a 1/4 turn to the right.  (3)  Make sure that the horse's mouth contains no feed.  (4)  Remove the cover from the tip of the syringe.  (5)  Insert the syringe tip into the horse's mouth at the space between the teeth.  (6)  Depress the plunger as far as it will go, depositing paste on the back of the tongue.  (7) Immediately raise the horse's head for a few seconds after dosing.


PARASITE CONTROL PROGRAM:  All horses should be included in a regular parasite control program with particular attention being paid to mares, foals and yearlings.  Foals should be treated initially at 6 to 8 weeks of age, and routine treatment repeated as appropriate.  Consult your veterinarian for a control program to meet your specific needs.  Bimectin (ivermectin) Paste effectively controls gastrointestinal nematodes and bots of horses.  Regular treatment will reduce the chances of verminous arteritis caused by Strongylus vulgaris.





PRODUCT ADVANTAGES:  Broad-spectrum Control - Bimectin (ivermectin) Paste kills important internal parasites, including bots and the arterial stages of S. vulgaris, with a singe dose.  Bimectin (ivermectin) Paste is a potent antiparasitic agent that is neither a benzimidazole nor an organophosphate.



ANIMAL SAFETY:  Bimectin (ivermectin) Paste may be used in horses of all ages, including mares at any stage of pregnancy.  Stallions may be treated without adversely affecting their fertility.



WARNING:  Do not use in horses intended for human consumption.


Not for use in humans.  Keep this and all drugs out of reach of children.  Refrain from smoking and eating when handling.  Wash hands after use.  Avoid contact with eyes.  The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information.  To report adverse reactions in users, to obtain more information or to obtain MSDS, contact Bimeda, Inc. at 1-888-524-6332.



Bimectin (ivermectin) Paste hs been formulated specifically for use in horses only.  This product should not be used in other animal species adverse reactions, including fatalities in dogs, may result.



Environmental Safety:  Ivermectin and excreted ivermectin residues may adversely affect aquatic organisms.  Do not contaminate ground or surface water.  Dispose of the syringe in an approved landfill or by incineration.



INFORMATION FOR HORSE OWNERS:  Swelling and itching reactions after treatment with Bimectin (ivermectin) Paste have occurred in horses carrying heavy infections of neck threadworms (Onchocerca sp. microfilariae).  These reactions were most likely the result of microfilariae dying in large numbers.  Symptomatic treatment ma be advisable.  Consult our veterinarian should an such reactions occur.  Healing of summer sores involving extensive tissue changes may require other appropriate therapy in conjunction with treatment with Bimectin (ivermectin) Paste.  Reinfection, and measures for its prevention, should also be considered.  Consult our veterinarian if the condition does not improve.



STORAGE INFORMATION:  Store at 68deg.F-77deg. F (20deg.-25deg.C).  Excursions between 59deg.F-86deg.F (15deg.C-30deg.C) are permitted.


TAKE TIME


OBSERVE LABEL DIRECTIONS



For Oral Use In Horses Only


Bimectin


(ivermectin)


Paste


1.87%


Anthelmintic and Boticide  


Net Wt. 0.21 oz (6.08 g)


Removes worms and bots with a single dose.


Contents will treat up to 1250 lb body weight


ANADA# 200-326, Approved by FDA


Bimeda


Apple Flavored










BIMECTIN 
ivermectin  paste










Product Information
Product TypeOTC ANIMAL DRUGNDC Product Code (Source)61133-6012
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ivermectin (Ivermectin)Ivermectin91 ug  in 6.08 g





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      


















Packaging
#NDCPackage DescriptionMultilevel Packaging
161133-6012-16.08 g In 1 SYRINGE, PLASTICNone
261133-6012-06.08 g In 1 POUCHNone
361133-6012-26.08 g In 1 CARTONNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20032601/19/2005


Labeler - Bimeda, Inc. Division of CrossVetpharm Group (043653216)

Registrant - Bimeda, Inc. Division of CrossVetpharm Group (043653216)









Establishment
NameAddressID/FEIOperations
Bimeda-MTC Animal Health, Division of Cross Vetpharm Group256232216manufacture
Revised: 05/2010Bimeda, Inc. Division of CrossVetpharm Group



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