ROMET 30- sulfadimethoxine and ormetoprim powder 
PHARMAQ AS

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ROMET 30

Sulfadimethoxine & Ormetoprim
Type A Medicated Article
For freshwater-reared salmonids (trout and salmon) and catfish

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.

For use in manufacturing medicated feeds only

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.

Labels for feeds containing Romet® 30 must contain appropriate indications, limitations and warnings as well as required feed ingredient information

Approved by FDA under NADA # 125-933

Marketed by

PHARMAQ

part of Zoetis

PHARMAQ AS

Skogmo Industriomrade

N-7863 Overhalla

Norway


US-4-6001 Net wt 50 LB (22.68 kg)

Take Time

Observe Label Directions

Made in USA

Package Label

image description

ROMET  30
sulfadimethoxine and ormetoprim powder
Product Information
Product TypeVFD TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:15331-0103
Route of AdministrationOral
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sulfadimethoxine (UNII: 30CPC5LDEX) (SULFADIMETHOXINE - UNII:30CPC5LDEX) Sulfadimethoxine113.5 g  in 0.45 kg
Ormetoprim (UNII: M3EFS94984) (ORMETOPRIM - UNII:M3EFS94984) Ormetoprim22.7 g  in 0.45 kg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15331-0103-122.68 kg in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA12593311/26/1984
Labeler - PHARMAQ AS (730355380)
Establishment
NameAddressID/FEIBusiness Operations
International Nutrition Inc968200175manufacture
Establishment
NameAddressID/FEIBusiness Operations
Jiangsu Tianhe Pharmaceutical Co., Ltd.421144690api manufacture

Revised: 7/2023
Document Id: 66aaaaf4-52f0-4d70-a60e-86466a252bc6
Set id: 67a9dc76-b404-4475-b080-cb7bf62dfc86
Version: 5
Effective Time: 20230718
 
PHARMAQ AS