Thursday, 23 August 2012

Equistrength




Generic Name: pyrantel pamoate paste

Dosage Form: FOR ANIMAL USE ONLY

Equistrength Paste (pyrantel pamoate) is a pale yellow to buff paste containing 43.9% w/w pyrantel pamoate in an inert vehicle.  Each syringe contains 3.6 grams pyrantel base in 23.6 grams paste.  Each milliliter contains 171 grams pyrantel base as pyrantel pamoate.


READ DIRECTIONS CAREFULLY BEFORE USING THIS PRODUCT.


COMPOSITION:  Pyrantel pamoate is a compound belonging to a family classified chemically as tetrahydropyrimidines.  It is a yellow, water-insoluble crystalline salt of the tetrahydropyrimidine base and pamoic acid containing 34.7% base activity.


The chemical structure and name are given below:


Chemical Name:


(E)-1,4,5,6-tetrahydro-1-methyl-2-[2-(2-thienyl)-vinyl]-pyrimidine 4,4' methylenebis [3-hydroxy-2 naphtholate] (1:1)



INDICATIONS:  For the removal and control of mature infections of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small strongyles; pinworms (Oxyuris equi); and large roundworms (Pasascaris equorum) in horses and ponies.


Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.





DOSAGE AND TREATMENT:  Equistrength Paste (pyrantel pamoate) is to be administered as a single oral dose of 3 milligrams pyrantel base per pound of body weight.  The syringe has four weight mark increments.  Each weight mark indicates the recommended dose for 300 pounds of body weight.


Dosage


Body Weight Range                                    Quantity                                          mg Pyrantel Base


up to 300 lb                                                1/4 syringe                                      900 mg


301 to 600 lb                                              1/2 syringe                                      1800 mg


601 to 900 lb                                              3/4 syringe                                      2700 mg


901 to 1200 lb                                            1 full syringe                                    3600 mg


NOTE:  Position ring-gauge over appropriate mark on plunger.


For maximum control of parasitism, it is recommended that foals (2-8 months of age) be dosed every 4 weeks.  To minimize the potential source of infection that the mare may pose to the foal, the mare should be treated 1 month prior to anticipated foaling date followed by re-treatment 10 days to 2 weeks after birth of foal.  Horses and ponies over 8 months of age should be routinely dosed every 6 weeks.  It is recommended that severely debilitated animals not be treated with this preparation.


ADMINISTRATION:   After removing the cap, the paste should be deposited on the dorsum of the tongue.  Introduce the nozzle end of the syringe at the corner of the mouth.  Direct the syringe backwards and depress the plunger to deposit the paste on the tongue.  Given in this manner, it is unlikely that rejection of the paste will occur.  Raising the horse's head sometimes assists in the swallowing process.  When only part of the paste has been used, replace the cap on the syringe nozzle.



EFFICACY:  Critical (worm count) studies in horses demonstrated that pyrantel pamoate administered at the recommended dosage was efficacious against mature infections of Strongylus vulgaris (>90%), S. edentatus (69%), S. equinus (>90%), Oxyuris equi (81%), Parascaris equorum (>90%), and small strongyles (>90%).



RESIDUE WARNING:  Not intended for use in horses intended for human consumption.



RECOMMENDED STORAGE:  Store at controlled room temperature 15 degrees - 30 degrees C (59 degrees - 86 degrees F).



Equistrength


(pyrantel pamoate)


PASTE


Equine Anthelmintic


FOR ORAL USE ONLY.


FOR ANIMAL USE ONLY.


KEEP OUT OF REACH OF CHILDREN.


ANADA 200-350, Approved by FDA


APPLE FLAVORED










Equistrength 
pyrantel pamoate  paste










Product Information
Product TypeOTC ANIMAL DRUGNDC Product Code (Source)46066-570
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrantel Pamoate (Pyrantel)Pyrantel Pamoate3.6 g  in 23.6 g





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      


















Packaging
#NDCPackage DescriptionMultilevel Packaging
146066-570-0123.6 g In 1 POUCHNone
246066-570-0223.6 g In 1 SYRINGE, PLASTICNone
346066-570-0323.6 g In 1 CARTONNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20035003/25/2003


Labeler - Aspen Veterinary Resources (627265361)

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









Establishment
NameAddressID/FEIOperations
Bimeda-MTC Animal Health256232216manufacture
Revised: 10/2010Aspen Veterinary Resources



No comments:

Post a Comment