Label: ROMET 30- sulfadimethoxine and ormetoprim powder

  • Category: VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated July 18, 2023

If you are a consumer or patient please visit this version.

  • 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.

  • 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

    image description

  • INGREDIENTS AND APPEARANCE
    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