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Animal NDC 15331-0103-1 Romet 30

Sulfadimethoxine And Ormetoprim

Animal Product Information

Field Name Field Value
Animal NDC Code 15331-0103-1
Proprietary Name Romet 30 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Sulfadimethoxine And Ormetoprim What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Pharmaq As
Product Type Vfd Type A Medicated Article Animal Drug
Usage Information
    For control of furunculosis in freshwater-reared salmonids (trout and salmon) caused by Aeromonas salmonicida and of enteric septicemia of catfish caused by Edwardsiella ictaluri strains susceptible to the sulfadimethoxine and ormetoprim combination.
Active Ingredient(s)
  • Ormetoprim
  • Sulfadimethoxine
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA125933 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Romet 30 Images

Romet 30 Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Caution:



Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian


Active Drug Ingredients



Sulfadidemthoxine 113.5 grams per pound (25%) ormetoprim 22.7 grams per pound (5%) in a carrier suitable for incorporation in feeds.


Indications



For control of furunculosis in freshwater-reared salmonids (trout and salmon) caused by Aeromonas salmonicida and of enteric septicemia of catfish caused by Edwardsiella ictaluri strains susceptible to the sulfadimethoxine and ormetoprim combination.


Preparation Of Medicated Feeds



Establish the weight of fish to be treated and calculate the amount of feed needed per day according to fish size and water temperature.  Calculate the amount of Romet® 30 required for medicating the feed at the rate of 16.7 g of Romet®30 per 100 kg (7.6 g of Romet® 30/100 lbs) of fish body weight per day.

Medication of feed before pelletizing or extruding

Thoroughly mix the calculated amount of Romet® 30 into the mash feed prior to pelletizing or extruding.  Refer to the dosage table below for recommended levels of use.

Feed Intake of Fish as

Percent (%) of Body Weight 

Lbs of Romet® 30

per Ton of Feed

 1 33.30
 2 16.70
 3 11.10
 4 8.33
 5 6.66
 6 5.55

Medication of feed after pelletizing

Prepare a liquid slurry by suspending Romet® 30 in a 5% gelatin solution.  Coat the pelleted fish feed with the slurry, which should be constantly agitated to ensure uniform suspension of the Romet® 30 during addition.  As a general rule, 10 gallons of gelatin solution is required to coat 2000 lb (1T) of pellets.  The coated pellets be allowed to dry prior to bagging.  Do NOT top dress pellets with Romet® 30 in a vegetable or fish oil suspension.


Use/Feeding Directions



Administer medicated feed daily for five consecutive days to provide approximately 50 mg of active ingredients per kg (23 mg/lb) of live body of fish per day.


Storage



Store dry in closed bag at or below 25° C (77° F), excursions permitted to 37° C (99° F)


Caution



If fish show no improvement within 2 to 3 days, or if signs of disease reappear after termination of treatment, reevaluate management practices, diagnosis of outbreak and establish susceptibility of the bacterial isolate(s) to the drug.


Warning



Withdraw 42 days in freshwater-reared salmonids (trout and salmon) and 3 days in catfish before slaughter or release as stocker fish.


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.