Friday, 18 May 2012

Equell





Dosage Form: FOR ANIMAL USE ONLY
Equell®

(ivermectin)

Paste 1.87%

Anthelmintic and Boticide

FOR ORAL USE IN HORSES ONLY


Removes worms and bots with a single dose.


Contents will treat up to 1320 lb body weight.


Net Weight: 0.225 oz (6.42 g)



INDICATIONS


Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism. Equell (ivermectin) Paste provides effective 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, T. serratus

  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, C. pateratum

  Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, C. brevicapsulatus

  Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, C. minutus

  Cylicodontophorus spp.

  Petrovinema poculatum


Small Strongyles (fourth-stage larvae)


Pinworms (adults and fourth-stage larvae)

  Oxyuris equi


Ascarids (adults and third- and fourth-stage larvae)

  Parascaris equorum


Hairworms (adults)

  Trichostrongylus axei


Large-mouth Stomach Worms (adults)

  Habronema muscae


Bots (oral and gastric stages)

  Gasterophilus spp. including G. intestinalis and G. nasalis


Lungworms (adults and fourth-stage larvae)

  Dictyocaulus arnfieldi


Intestinal Threadworms (adults)

  Strongyloides westeri


Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae


Dermatitis caused by Neck Threadworm microfilariae, Onchocerca sp.



Equell Dosage and Administration


This syringe contains sufficient paste to treat one 1320-lb horse at the recommended dose rate of 91 mcg ivermectin per lb (200 mcg/kg) of body weight. Each weight marking on the syringe plunger delivers enough paste to treat 250 lb (114 kg) of body weight.


  1. While holding plunger, turn the 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. Equell 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

Equell Paste kills important internal parasites, including bots and the arterial stages of S. vulgaris, with a single dose. Equell Paste is a potent antiparasitic agent that is neither a benzimidazole nor an organophosphate.



ANIMAL SAFETY


Equell 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.



Warnings


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 a MSDS, contact Bimeda, Inc. at 1-888-524-6332.



Precautions


Equell Paste has been formulated specifically for use in horses only. This product should not be used in other animal species as severe 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.



Store at room temperature (25°C/77°F), with excursions permitted between 15°- 30°C (59°- 86°F).



INFORMATION FOR HORSE OWNERS


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



ANADA 200-320, Approved by FDA


Manufactured by:

Virbac AH Inc.

3200 Meacham Blvd

Fort Worth, Texas 76137


Distributed by:

Bimeda, Inc.

Le Sueur, MN 56058


Equell is a Registered Trademark of Virbac SA.


November 2009


301981-01



PRINCIPAL DISPLAY PANEL - 6.42 g Syringe Carton


Equell®

(ivermectin)


Paste 1.87%


Anthelmintic and Boticide


Removes worms and bots with a single dose.


Contents will treat up to 1320 lb. body weight.


FOR ORAL USE IN HORSES ONLY


Net Weight: 0.225 oz (6.42 g)


ANADA 200-320, Approved by FDA


Bimeda










Equell 
ivermectin  paste










Product Information
Product TypeOTC ANIMAL DRUGNDC Product Code (Source)61133-7010
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ivermectin (Ivermectin)Ivermectin200 ug





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
161133-7010-11 SYRINGE In 1 CARTONNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20032001/14/2010


Labeler - Bimeda Inc (043653216)

Registrant - Virbac AH Inc (131568396)









Establishment
NameAddressID/FEIOperations
Virbac Bridgeton808558100MANUFACTURE
Revised: 01/2010Bimeda Inc



No comments:

Post a Comment