ROMET

Manufacturer
PHARMAQ AS | International Nutrition Inc | Jiangsu Tianhe Pharmaceutical Co., Ltd.
Effective date
2023-07-18
Label type
VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:42:09

Label at a glance#

ProductROMET 30
Active ingredientSulfadimethoxine, Ormetoprim
Label structure11 sections

Dosage and administration

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 and handling

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

Label contents#

Full prescribing information#

CAUTION:

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

Indications

INDICATIONS & USAGE SECTION

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

SPL UNCLASSIFIED SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Caution

PRECAUTIONS SECTION

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

RESIDUE WARNING SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15331-0103-1ROMET3022.68 kg in 1 CONTAINERPowder22.685

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15331-0103ROMET 30 (SULFADIMETHOXINE AND ORMETOPRIM) POWDER [PHARMAQ AS]51 package rows20230719_67a9dc76-b404-4475-b080-cb7bf62dfc86.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15331-010315331-0103-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
Sulfadimethoxine30CPC5LDEXACTIB
OrmetoprimM3EFS94984ACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.