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What is Included on the Label?
A label is a display of written, printed, or graphic information attached to the container of a drug. Let’s use the antimicrobial product called NuflorⓇ as an example. Click on each number or heading below to learn more:
1. Prescription Status
The ‘Pr’ symbol indicates that this drug is a prescription drug. To access this drug, a veterinary prescription is required. In Ontario, provided you have a valid prescription, you are only allowed to purchase prescription veterinary drugs from a veterinarian, pharmacist, or, if mixed into a feed, from a feed mill. Drugs that are available over the counter will not have this symbol.
2. Product Name
This is the product or brand name that is used by the manufacturer to identify and market the drug. It is registered with the government and may be a registered trademark (™ or Ⓡ) of the manufacturer.
3. Active Ingredient
The active ingredient is the generic name of the drug and describes the part of the product that is responsible for performing the action claimed on the label. The label shows how much of the ingredient is in the product and the concentration (strength). In the case of NuflorⓇ, the active ingredient responsible for killing bacteria is the antimicrobial florfenicol at a concentration of 300 mg/mL.
4. Drug Identification Number
This number is assigned by the federal government to indicate that the drug has passed regulatory tests and can be used as approved on the label. If the product does not have a DIN number, it should not be used in animals.
5. Product Description
The description will contain information on the color and viscosity of the solution, as well as the ingredients found in each milliliter of the drug.
Nuflor’s description reads: “NUFLORⓇ is a light yellow to straw colored, slightly viscous solution. Each millilitre contains 300 mg florfenicol, 250 mg N-methyl-2-pyrorolidone, polyethylene glycol 300 q.s. 1.0 mL and 150 mg propylene glycol as a preservative.”
6. Indications for Use
This portion of the label contains information on what disease(s) the product should be used to treat and specific bacteria it is effective against. The indications component of the label will also provide information on what species (e.g. cattle, swine, poultry, horses) and class (lactating, gestating, weaned) of animal this drug is approved for.
NUFLORⓇ’s label reads: “CATTLE: For the treatment of bovine respiratory disease complex, also called shipping fever, associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni (Haemophilus somnus) and for the reduction of morbidity associated with bovine respiratory disease (BRD) in feedlot calves, caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni (Haemophilus somnus), during the first 28 days in the feedlot, when administered at the time of arrival. Also for the treatment of bovine interdigital phlegmon (foot rot, interdigital necrobacillosis, infectious pododermatitis) associated with Fuso bacterium necrophorum and Bacteroides melaninogenicus and for the treatment of infectious bovine keratoconjuctivitis (IBK, pinkeye) caused by Moraxella bovis. SWINE: NUFLORⓇ Injectable Solution is indicated for the treatment of swine respiratory diseases associated with Actinobacillus pleuropneumoniae and Pasturella multocida.”
7. Dosage and Administration
Information will be provided on the route (e.g. intramuscular, oral, intravenous) by which the drug should be administered, the dosage (milligrams per kilogram of body weight), and amount injected per site.
NUFLORⓇ’s label reads: “CATTLE: NUFLORⓇ Injectable Solution should be administered to cattle either by a single subcutaneous injection at a dose rate of 40 mg/kg body weight (6 mL/45 kg); or by intramuscular injection at a dose of 20 mg/kg body weight (3 mL/45 kg), a total of two doses with a 48 hour interval should be given. For feedlot calves at high risk of developing BRD, only the subcutaneous route (SC) of administration (40 mg/kg, once on arrival in the feedlot) is recommended. Do not inject more than 10 mL into a single site. SWINE: NUFLORⓇ Injectable Solution should be administered by intramuscular injection at a dose rate of 15 mg/kg body weight (2.25 mL/45 kg). A second dose should be administered 48 hours later. Do not inject more than 5 mL into a single site. The injection should only be given in the neck.
Clinical improvement should be evident in most treated subjects within 24 hours of initiation of treatment. If a positive response is not noted within 72 hours of initiation of treatment, the diagnosis should be reevaluated.”
8. Warnings and Withdrawal Times
This portion of the label will provide information on species and classes of animals in which drug cannot be used, as well as when the drug cannot be used. It will also provide the withdrawal time for the drug. Drug withdrawal time is the time required for the drug to clear from the animal’s system to prevent a violative residue. Food animals and their products must not be used for food within this time following treatment.
NUFLORⓇ’s label reads: CATTLE: Treated animals must not be slaughtered for use in food for at least 36 days after the latest intramuscular treatment or for at least 55 days after the latest subcutaneous treatment with this drug. Not for use in dairy cows 20 months of age or older. Not for use in veal calves. The withdrawal period has not been established in pre-ruminating calves. To limit the potential development of antimicrobial resistance, NUFLORⓇ should only be used as an arrival treatment in feedlot calves when BRD has been diagnosed and calves are at high risk of developing BRD. SWINE: Treated pigs must not be slaughtered for use in food for at least 15 days after the latest treatment with this drug. Note: to reduce the possibility of excess trim at the site of injection, do not slaughter swine for at least 21 days after the latest treatment with this drug. Keep out of reach of children.”
The caution section describes the side effects that the drug may have in treated animals. Following treatment it is important to monitor the animal for side effects, and when present, discontinue therapy.
NUFLORⓇ’s label reads: “Transient diarrhea or transient inappetence may occur with the use of this drug. Appetite and stool will usually return to normal within a few days of the end of the treatment period. In swine, peri-anal inflammation and/or rectal eversion may be observed in more than 50% of treated animals. These effects should resolve completely within one week. Not for use in breeding cattle or breeding swine. The effects of florfenicol on bovine or porcine reproductive performance, pregnancy, and lactation have not been assessed.”
10. Storage Conditions
This section provides information on how you should store the drugs. It includes information on required storage temperatures (e.g. room temperature, refrigeration), as well as exposure to light.
NUFLORⓇ’s label reads: “Product should be stored between 2° and 25°C (36° and 77°F).”