...the provisions of this regulation in respect of a supplier label and a material safety data sheet do not apply where the controlled product is an ...drug or food within the meaning of the Food and Drug Act (Canada). (section 2.(2)b.)

Products regulated under the Food and Drug Act will have approved labeling and/or package inserts.  The information below is the approved label information from these labels.  This information is provided for informational purposes only and does not imply  that they are Syndel products or available from Syndel.

AQUAFLOR®
Schering-Plough
Feed Medication
Florfenicol 50% Medicated Premix
DIN: 02231742
Active Ingredient(s): Each kg of AQUAFLOR® Premix contains 500 g (50%) of florfenicol in a palatable base.
Indications: For the treatment of furunculosis caused by susceptible strains of Aeromonas salmonicida in salmon.
Pharmacology: AQUAFLOR®, a synthetic broad spectrum antibiotic which inhibits bacteria by interfering with protein synthesis, is active in vitro against a number of important bacterial pathogens of salmon including: Aeromonas salmonicida, Vibrio salmonicida, Vibrio anguillarum and Yersinia ruckeri. AQUAFLOR® is rapidly absorbed from the intestine of salmon when administered in medicated feed. It is excreted mainly in the urine and bile.
Dosage and Administration: Mix in unmedicated feed prior to pelleting, or use to surface coat pelleted feed. Feed mixture should deliver 10 mg florfenicol/kg body weight. Administer for 10 consecutive days. See Table for recommended AQUAFLOR® feed inclusion rate.
Recommended AQUAFLOR® Inclusion Rates for Preparation of Medicated Feed:

For surface coating at the farm premises: Using a cement mixer or equivalent equipment, mix thoroughly the contents of one 25 kg bag of unmedicated fish feed with the amount of AQUAFLOR® calculated based on feeding rate (for example; at a feeding rate of 1% of body weight, 50 grams of AQUAFLOR® should be added per 25 kg bag of feed). Then add approximately 1 litre of an edible fish or vegetable oil and mix together for several minutes more to ensure uniform coating.
Withdrawal Time: Treated fish must not he harvested for use in food, or released as stocker fish, for at least 12 days after the latest treatment with this drug.
Precaution(s): Store in a dry place between 2°-30°C. Use premix within 12 months of opening pouch. Use medicated feed not more than 6 months after manufacture. Keep separate from other feeds.
Warning(s): Treated fish must not he harvested for use in food, or released as stocker fish, for at least 12 days after the latest treatment with this drug. Do not use in fish maintained at water temperatures <5°C. Avoid inhalation of dust and contact with skin and eyes. Wear protective clothing (mask and gloves). Wash hands after handling.
Keep this and all medication out of the reach of children.
For veterinary use only.
Presentation: AQUAFLOR® is provided in individual 2 kg sealed laminated foil pouches.
Disclaimer: Every effort has been made to ensure the accuracy of the information published. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the product label or package insert. Compendium Code No.: 2400092

TERRAMYCIN-AQUA*
Phibro Animal Health
Oxytetracycline-Oral
Fish and lobster premix
DIN: 00607657
Active Ingredient(s): Each kg contains:

Indications:
Salmonids: For the treatment of ulcer disease caused by Haemophilus piscium, furunculosis caused by Aeromonas salmonicida, columnaris disease caused by Chondrococcus (Flexibacter) columnaris, coldwater disease caused by Cytophaga psychrophila and enteric redmouth disease caused by Yersinia ruckeri in salmon and trout.
Lobsters: For the prevention and treatment of gaffkemia (red tail) caused by Aerococcus viridans in lobsters (Homarus spp.) held in lobster cars or pounds.
Dosage and Administration: Mixing Directions:
Salmonids: Thoroughly mix TERRAMYCIN-AQUA* with complete fish feed in quantities that will depend upon the fish feeding rate to be used as per the table below, to obtain a medicated feed that will provide 75 mg of oxytetracycline hydrochloride per kg of fish per day. The medicated feeds can be prepared in the form of meal or pellets.

Lobsters: Thoroughly mix 5 kg of TERRAMYCIN-AQUA* with 995 kg of complete lobster feed to obtain a medicated feed with an oxytetracycline hydrochloride concentration of 0.22% (2,200 mg/kg). The medicated feed can be prepared in the form of meal or pellets.
Feeding Directions:
Salmonids: The medicated feeds are to be fed as the sole ration for 10 consecutive days. If mortality is not reduced by the fifth day of treatment, the diagnosis should be re-evaluated.
Lobsters: Feed as the sole ration for five (5) consecutive days following the introduction of each new batch of lobsters into a confinement area. Feed to appetite at approximately 1 kg of medicated ration per 450 kg of lobsters per day.
Withdrawal Time: Salmonids: Treated fish must not be liberated or slaughtered for use in food for at least 40 days (when the water temperature is 10°C or higher), or 80 days (when the water temperature is below 10°C) after the last treatment with this drug.
Lobsters: Treated lobsters must not be marketed for use in food for at least 30 days after the last treatment with this drug.
Precaution(s): Store at room temperature.
Caution(s):
1. In fish and lobster feeds having a high ash content, ions of Ca, Fe, Cu and Zn may bind with oxytetracycline retarding its absorption from the gut.
2. Do not use in feeds containing the pellet-binding agent bentonite.
Warning(s):
Salmonids: Treated fish must not be liberated or slaughtered for use in food for at least 40 days (when the water temperature is 10°C or higher), or 80 days (when the water temperature is below 10°C) after the last treatment with this drug.
Lobsters: Treated lobsters must not be marketed for use in food for at least 30 days after the last treatment with this drug.
Presentation: 25 kg paper bags.
*Registered trade-mark of Pfizer Products Inc.;
Pfizer Canada Inc. licensee.
Disclaimer: Every effort has been made to ensure the accuracy of the information published. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the product label or package insert. Compendium Code No.: 2109040

TRIBRISSEN® 40% POWDER
Pr
Schering-Plough
Feed Medication
Trimethoprim and sulfadiazine powder - Antibacterial
DIN: 01934031
Active Ingredient(s): Each kg contains:

Indications: For the treatment of disease in salmon caused by Vibrio anguillarum.
Dosage and Administration: 30 mg combined active ingredients (75 mg powder) per kg of body weight of fish per day. The treatment should be continued for a period of 7-10 days.
The following inclusion rates will provide the recommended dose:

TRIBRISSEN® 40% Powder is intended solely for administration in feed. It may be incorporated into the feed at the time of manufacture or mixed with the manufactured feed prior to feeding.
To add TRIBRISSEN® 40% Powder to the already manufactured feed pellets, edible oil should first be added to the day's ration at the rate of 1 L per 25 kg of pellets in a mixer. The calculated dose of TRIBRISSEN® 40% Powder (7.5 g per 100 kg of fish if using a feed rate of 1% body weight) is then sprinkled into the mixer while mixing so as to adhere to the surface of the pellets.
Withdrawal Time: Treated fish must not be harvested for use in food or released as stocker fish for at least 80 days after the last treatment with the drug.
Precaution(s): Store in the original container in a dry place. Protect from light. Reclose partly used containers.
Warning(s): Treated fish must not be harvested for use in food or released as stocker fish for at least 80 days after the last treatment with the drug.
Presentation: 20 kg metal drum.
Disclaimer: Every effort has been made to ensure the accuracy of the information published. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the product label or package insert. Compendium Code No.: 2400057

ROMET®-30
Pr
Pharmaq AS
Feed Medication
Antibacterial medicated premix
DIN: 00797162
Active Ingredient(s): Each kg contains:

*Indicated as percent (%) of body weight.
Medication of feed after pelletizing: Prepare a liquid slurry by suspending the premix in edible vegetable oil or a 5% gelatin solution. Coat the pelleted fish feed with the slurry, which should be constantly agitated to ensure uniform suspension of the premix during addition. As a general rule, 1 L of vegetable oil or gelatin solution is required to coat 25 kg of pellets.
For example: To medicate 3,000 kg of fish for one (1) day with a 3% body weight feed intake, mix 153 g of premix with 4 L of vegetable oil to prepare a slurry to be used for coating 90 kg of pellets. The pellets may be placed in a cement mixer (if 25 kg or more is to be coated) or spread on plastic or a smooth concrete surface for the coating process.
The pellets should be mixed constantly, but gently, while the slurry is being slowly added to ensure even distribution without undue pellet breakage. The coated pellets are then spread out and allowed to air dry for several hours. Rebag the coated pellets and store them under proper feed storage conditions.
Note: If fish do not show improvement within two (2) to three (3) days, or if signs of disease re-appear after the termination of treatment, re-evaluate the management practices, diagnosis of outbreak, and establish susceptibility of the bacterial isolate(s) to the drug.
Withdrawal Time: Treated fish must not be released as stocker fish or slaughtered for use in food for at least 42 days after the last treatment with this drug when the water temperature is 10°C or above.
Warning(s): Treated fish must not be released as stocker fish or slaughtered for use in food for at least 42 days after the last treatment with this drug when the water temperature is 10°C or above. Do not use when the water temperature is below 10°C.
Presentation: 25 kg bags.
Disclaimer: Every effort has been made to ensure the accuracy of the information published. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the product label or package insert. Compendium Code No.: 1768005

OXYSOL-220
A.P.A.
Feed additive
Antibiotic
DIN: 01943677
Active Ingredient(s): A medicated feed premix containing per kg:

Indications:
Lobsters (Homarus spp.): For use in the prevention and treatment of gaffkemia (red tail) caused by Aerococcus viridans held in lobster cars or pounds.
Dosage and Administration:
Lobsters (Homarus spp.):
Gaffkemia (red tail): 10 kg of OXYSOL-220 per metric tonne of complete feed. Feed as the sole ration for five (5) consecutive days following the introduction of each new batch of lobsters into a confinement area. Feed to appetite at approximately 1 kg of medicated ration per 450 kg of lobsters per day.
Withdrawal TimeTreated lobsters must not be marketed for use in food for at least 30 days after the last treatment with this drug.
Precaution(s): Protect from excessive heat and moisture.
Warning(s): Treated lobsters must not be marketed for use in food for at least 30 days after the last treatment with this drug.
Presentation: 25 kg bags.
Disclaimer: Every effort has been made to ensure the accuracy of the information published. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the product label or package insert. Compendium Code No.: 2210125

SALMOSAN® 50WP
Novartis
Parasiticide-Aquaculture
Acaricide (restricted)
Reg. No.: 24,528 P.C.P. Act
Active Ingredient(s):

Indications: Wettable Powder (WP) acaricide for the control of sea lice on fish reared in marine aquaculture sites in Eastern Canada.
Directions for Use: Nature of Restriction: For use in the control of sea lice causing damage in fish farm production (marine aquaculture) under the supervision of fish veterinarians and certified pesticide applicators as defined by provincial permit conditions. Please refer to the section Threshold Limit for Sea Lice which was developed in conjunction with provincial authorities in support of the sea lice management strategies.
General information: SALMOSAN® 50WP should be applied to salmon infested with mature (pre-adult or adult) sea lice (Lepeophtheirus salmonis or Caligus elongatus) before the stage at which serious skin damage is evident. Mortality may occur where fish are severely stressed or injured. The exact timing of a treatment programme is a matter of expertise and judgement: operators must seek the advice of the prescribing fish veterinarian. Do not use SALMOSAN® 50WP prophylactically. Use only when infestation has been diagnosed.
Threshold Limit for Sea Lice: Treatment is considered necessary when in individual fish pens a total of 40-100 pre-adult or adult lice or a total of 5 gravid females are present on a 20 fish sample.
Timing of application: SALMOSAN® 50WP does not affect juvenile attached sea lice including most chalimus stages which may be present with the pre-adult and adult stages. These juvenile stages will develop into pre-adults and adults in 10 to 20 days, when a population count should show whether a second treatment is necessary. Re-treatment will depend on the monitoring of fish pens and whether the sea lice levels exceed the Threshold Limit.
Application rates: Fish infested with sea lice should be bathed in 0.2 ppm SALMOSAN® 50WP (0.1 ppm azamethiphos) for a period of not less than 30 minutes and not more than 60 minutes.
Note: Initial dilution of SALMOSAN® 50WP when formulated in water at pH of 5.5 or less is stable for at least 5 days.
Oxygenation must be provided during treatment. Vigorous oxygenation is recommended in the treatment cage. Where several cages are to be treated a large reservoir of oxygen bottles should be available. During treatment, careful observation of fish behaviour must be maintained. If signs of distress, e.g. fish falling on their sides, occur, remove tarpaulin and ensure vigorous oxygenation of the water.
Note: At water temperatures above 10°C, it is advisable to limit treatment periods to 30 minutes.
Instructions:
Note: Maximum use rate: In order to prevent or reduce adverse affects to sensitive aquatic life, the maximum amount of SALMOSAN® 50WP used in an aquaculture site is 15 bags (i.e. 300 grams) per day, except for the hundred meter circle pen (i.e. 480 grams).
Twenty grams of SALMOSAN® 50WP will treat 100 m3 of water. Follow introduction procedure to fish pens under tarpaulin (bath) treatment. The pen size, numbers of fish, age and size of the fish and depth of Dry Up* (amount of water in the pen using a tarpaulin to reduce water volume) can affect the amount of SALMOSAN® 50WP needed to treat each pen. Timing for best treatment period should consider tidal movements (flushing rates) at the site which could affect dispersal of SALMOSAN® 50WP once the tarpaulins are removed.
Prior to treatment, operators wearing suitable equipment and protective clothing (see Precautions) should pre-mix the required number of water soluble bags of SALMOSAN® 50WP into a mixing container containing a minimum of 50 liters of sea water to ensure the solubags dissolve. Ensure adequate agitation during application.
If treatment is not conducted immediately after the initial dilution is made, re-suspension is necessary. Screw the lid tightly onto the container and gently shake this initial dilution for up to 5 minutes.
When fish are ready to be treated, the diluted suspension of SALMOSAN® 50WP should be immediately and carefully added to the cage by pouring or pumping the mixture into the water at the oxygen diffuser points using The Bath Technique.
The Bath Technique: In this technique, the depth of the fish cage net is reduced to a known depth at the centre, e.g. 2 metres, and a tarpaulin placed around the net so that it is totally enclosed. Ensure the base of the cage is not drooping when in the raised position as fish may congregate and come to harm. Oxygen is immediately bled into the system and diluted SALMOSAN® 50WP is added. After 30 to 60 minutes the tarpaulin is removed. Use an oxygen meter throughout treatment period.
This chart is for information and can act as a guide to the amount of SALMOSAN® 50WP needed. The amount to be used in individual pens will be the responsibility of the certified applicator based on site conditions as described above.

* Rate based on maximum 0.1 ppm azamethiphos or 100 mg/m³. Figures reflect volume Dry Up to ½ pen volume in Bath Treatment, one needs to take into consideration: pen size, numbers of fish, age and size of the fish, and amount to Dry Up.
Withdrawal Time: Do not treat within 48 hours of slaughter.
Precaution(s): May cause sensitization by inhalation and skin contact.
Avoid all contact by mouth, with skin or eyes.
Accidental splashes on exposed skin or eyes should be washed off immediately with plenty of water.
Wash hands, face and exposed skin before eating, drinking, or smoking, and after leaving the work area.
Wash all protective clothing thoroughly after use, especially the insides of gloves.
Wear suitable protective clothing (waterproof coveralls), suitable protective gloves (heavy duty gauntlet style nitrile or chemical-resistant gloves at least 300 mm in length and 0.5 mm thick are recommended), and face protection (face shield) when mixing and handling this product and when applying the diluted chemical to the pen. Renew protective clothing and gloves regularly and certainly when cracking or damage has occurred.
Store in the original, unopened packaging in a well-ventilated room. Store in a dry place. Protect from sun and humidity.
Avoid contamination of food, feed and domestic water supplies.
Do not touch water soluble bags with wet gloves as they will dissolve. Do not open water soluble bags. The water soluble bag should be dropped straight into the mixing container.
First Aid: If you have breathing problems or if you have felt persistently unwell after using a product containing an organophosphorus compound, you should consult your doctor before working with SALMOSAN® 50WP.
In case of accident or if you feel unwell, seek medical advice immediately. Tell the doctor you have been using SALMOSAN® 50WP which contains azamethiphos, an organophosphorus compound.
Ingestion: Medical aid necessary. Prevent exertion. Call doctor at once or Poison Control Centre and retain the label. Watch respiration and institute artificial respiration at first signs of respiratory failure.
Skin contact: Wash hands and exposed skin with soap and water.
Eye contact: Flush with clean water for 15-20 minutes. Seek medical advice.
Inhalation: Remove to fresh air. Keep at rest and keep warm.
Environmental Hazards:
1. SALMOSAN® 50WP is dangerous to many organisms. The fastest and therefore most important detoxification mechanism in coastal waters is dilution which is increased by water movements, including the flushing effect of sea tides.
2. SALMOSAN® 50WP is dangerous to fish and other aquatic organisms in the concentrated form or improper use dilutions. Do not contaminate ponds, streams, or inlets with product or used packaging.
Toxicological Information: The symptoms of mild poisoning from organophosphorus compounds are a feeling of exhaustion and weakness which may be accompanied by cramp-like abdominal pains, diarrhoea, excessive sweating, constricted pupils and salivation up to 24 hours after exposure. Severe poisoning can cause general muscle twitching and convulsions.
Azamethiphos is a cholinesterase inhibitor. Antidote: Atropine under medical supervision. Inject 2 to 4 mg atropine sulphate (for children 0.5 to 2 mg according to age) i.v. or i.m. every 5 to 10 minutes until signs of atropinisation occur. The patient must remain atropinised for a sufficient length of time (24 to 48 hours) to prevent subsequent poisoning due to delayed resorption.
Storage and Disposal: Store above freezing in a dry location. Prolonged storage at temperatures below 0°C may cause the water soluble bag to become brittle.
Product Decontamination and Disposal:
1. Make the empty pouch unsuitable for further use.
2. Dispose of the pouch in accordance with the provincial requirements.
3. For information on the disposal of unused, unwanted product, and the cleanup of spills, contact the Provincial Regulatory Agency or Novartis Animal Health Canada Inc.
Warning(s): Do not treat within 48 hours of slaughter.
Keep out of reach of children.
Disclaimer: Notice to User: This control product is to be used only in accordance with the directions on this label. It is an offence under the Pest Control Products Act to use a control product under unsafe conditions.
Notice to Buyer: Seller's guarantee shall be limited to the terms set out on the label and subject thereto, the buyer assumes the risk to persons or property arising from the use or handling of this product and accepts the product on that condition.
Presentation: 5 x 20 g pouches.
® SALMOSAN is a registered trademark of Novartis Animal Health Canada Inc.
Disclaimer: Every effort has been made to ensure the accuracy of the information published. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the product label or package insert. Compendium Code No.: 3220019

OXYSOL 1000
A.P.A.
Water Medication
Oxytetracycline HCl Soluble Powder
DIN: 00849340
Active Ingredient(s): per g

Oxytetracycline HCl USP

1000 mg

Indications: Water soluble antibiotic for chickens, turkeys, swine, calves, sheep and lambs.
As an aid in the treatment of infections caused by or associated with microorganisms sensitive to oxytetracycline HCl.
Chickens and turkeys: Chronic Respiratory Disease (C.R.D.), Bluecomb, cholera, enteritis and Hexamitiasis.
Swine, calves, sheep and lambs: Enteritis (diarrhea) and respiratory diseases.
Pharmacology: Description: Oxytetracycline HCl is an antibiotic similar to tetracycline and chlortetracycline in bacterial spectrum. Oxytetracycline is rapidly absorbed and effective in the treatment of many diseases due to Gram-positive and Gram-negative bacteria, spirochetes, Rickettsia and some Chlamydia.
Dosage and Administration:
Chickens and turkeys: Add 1 g of powder per 20 L or 100 g of powder per 2000 L of drinking water for 3 to 5 days.
For automatic proportioner: Set the apparatus to distribute 30 mL per 4 L of drinking water (1 oz/gallon U.S.). Prepare the stock solution by dissolving 25 g of powder in 3.8 L of water. This will medicate 500 L of drinking water.
Swine (scours and respiratory diseases): Add 1 g of powder per 100 kg of body weight every 12 hours, given as a drench using a dose syringe or 1 g of powder per 8 L or 25 g of powder per 200 L of drinking water for 4 or 5 days.
For automatic proportioner: Set the apparatus to distribute 30 mL per 4 L of drinking water (1 oz/gallon U.S.). Prepare the stock solution by dissolving 50 g of powder in 3 L of water. This will medicate 400 L of drinking water.
Calves (scours): Add 1 g of powder per 200 kg of body weight every 12 hours, given as a drench in water or 25 g of powder per 225 L of drinking water for 3 to 5 days.
Calves (respiratory diseases): Double above dosage.
Sheep and lambs (scours and respiratory diseases): 1 g of powder per 100 kg of body weight every 12 hours given as a drench in water for 4 or 5 days.
Notes:
Only medicated drinking water should be provided during the treatment period and fresh solutions should be prepared daily.
The measuring cup contained herein when filled with a level quantity provides approx. 25 g of product.
Precaution(s): Storage Conditions: Protect from excessive heat and moisture.
Caution(s): For veterinary use only.
Warning(s): Treated animals must not be slaughtered for use as food for at least: Chickens and Turkeys - 7 days; Swine, Calves and Lambs - 10 days after the latest treatment with this drug. This product must not be used in laying birds.
Presentation: 25 kg.
656935C
Disclaimer: Every effort has been made to ensure the accuracy of the information published. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the product label or package insert. Compendium Code No.: 2210012

GALLIMYCIN® 200
A.P.A.
Erythromycin
DIN: 02172674
Active Ingredient(s): GALLIMYCIN® 200 is a sterile solution containing per mL:

Erythromycin base

200 mg

Indications: GALLIMYCIN® 200 is indicated for the effective treatment of disease conditions due to organisms sensitive to erythromycin.
Swine: For the treatment of respiratory syndrome (pneumonia, rhinitis and bronchitis) and as an aid in the management of mastitis, metritis, and leptospirosis in sows at farrowing time and scours in young pigs.
Cattle: For the treatment of pneumonia and shipping fever (following stress from handling and transportation) and for the systemic treatment of mastitis, metritis, and infectious pododermatitis (foot rot).
Sheep: As an aid in the prevention of lamb dysentery caused by erythromycin-sensitive strains of Clostridium perfringens and in the treatment of upper respiratory infections.
Pharmacology: Erythromycin is an antibiotic of low toxicity produced during the growth of the micro-organism, Streptomyces erythreus. The safety of erythromycin and its effectiveness in the treatment of various diseases of both humans and animals are well established. Because of its therapeutic importance, the antibiotic has been marketed for many years in various chemical forms and in numerous dosage forms.
Original studies on erythromycin established the effectiveness of this antibiotic against gram-positive organisms. It has a wide range of activity, particularly against staphylococci, streptococci, and pneumococci.
Dosage and Administration:
Swine:
For the treatment of scours in young pigs, the usual dose is 22 mg/kg (0.11 mL/kg) of body weight administered once a day. Do not administer to pigs of less than 2.25 kg of body weight.
For upper respiratory infections and pneumonia, leptospirosis, mastitis, metritis, the usual dose is 2.2 to 6.6 mg/kg (0.011 to 0.033 mL/kg) of body weight administered once a day.
Cattle:
The usual dose is 2.2 to 4.4 mg/kg (0.011 to 0.022 mL/kg) of body weight administered once a day.
Sheep:
To aid in the prevention of dysentery* in newborn lambs, the dose is 11 mg/kg (0.055 mL/kg) of body weight, administered once a day. Do not administer to lambs of less than 4.5 kg of body weight.
*Where organisms sensitive to erythromycin may be the infective agents.
For the treatment of upper respiratory infections in older animals, the usual dose is 2.2 mg/kg (0.011 mL/kg) of body weight administered once a day.
Temporary tissue irritation follows injection. Thus, to avoid excessive trim, do not slaughter animals within:

Swine and Sheep	10 days
Cattle	21 days

of the last injection with this drug.
Administration: Swine, Cattle and Sheep: GALLIMYCIN® 200 is designed for intramuscular administration by deep injection into the heavy musculature of the neck or limbs. Where more than one (1) treatment is required, it is advisable to vary the site of injection.
The drug should not be given intravenously or intraperitoneally. Subcutaneous injections should be avoided. For young pigs, it is recommended that a 19- or 20-gauge, 1.9 or 2.5 cm needle be used. For larger animals, either a 16- or 18-gauge, 5.0 cm needle may be used.
Precaution(s): Thoroughly clean and sterilize syringes and needles before using (needles and syringes may be sterilized by boiling in water for 15 minutes).
Use all precautions to prevent contamination of the contents of the bottle.
The injection site should be disinfected with a suitable disinfectant such as 70% isopropyl alcohol just prior to injecting GALLIMYCIN® 200.
Store between 5 and 15°C.
Caution(s): During extensive clinical investigation of GALLIMYCIN® 200, significant side effects were not reported. However, since there may be transient soreness, it is advisable to alternate the site of injection when more than one treatment is required.
Swelling or soreness encountered at the site of injection is usually mild, and disappears in one or two days. Deep intramuscular injections will minimize the incidence of local soreness and swelling.
Warning(s): Milk taken from treated animals during treatment and within 72 hours after the latest treatment must not be used as food.
Treated animals must not be slaughtered for use as food for at least:

Swine	7 days
Cattle	14 days
Sheep	3 days

after the last treatment with this drug.
Presentation: 100 mL vials.
® Registered Trademark of Abbott Laboratories, Ltd.
Disclaimer: Every effort has been made to ensure the accuracy of the information published. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the product label or package insert. Compendium Code No.: 2218041

GALLIMYCIN® PFC
A.P.A.
Water Medication
Erythromycin soluble powder
DIN: 00763632
Active Ingredient(s): Each gram contains:

Erythromycin (as erythromycin phosphate)

231.2 mg

Indications: Chickens and Turkeys: For use as an aid in the treatment and control of chronic respiratory disease (due to M. gallisepticum susceptible to erythromycin) and infectious coryza.
For use as an aid in the management of complex disease syndromes such as bluecomb and synovitis (caused by PPLO or coccal organisms), and in the management of respiratory outbreaks and syndromes resulting from the stresses of vaccination, debeaking and movement of birds.
Dosage and Administration: Chickens and Turkeys:
Respiratory diseases and complex disease syndromes: 4 g of powder per 8 L, or 100 g (one (1) pouch) per 200 L of drinking water and mix thoroughly.
For automatic proportioners: Set the apparatus to distribute 30 mL per 4 L of drinking water (1 oz./gallon U.S.). Prepare the stock solution by dissolving 250 g (two and one-half (2½) pouches) in 3.8 L of water. This will medicate approximately 500 L of drinking water.
Stresses: 2 g of powder per 8 L, or 50 g (one-half (½) pouch) per 200 L of drinking water and mix thoroughly.
For automatic proportioners: Set the apparatus to distribute 30 mL per 4 L of drinking water (1 oz./gallon U.S.). Prepare the stock solution by dissolving 125 g (one and one-quarter (1¼) pouch) in 3.8 L of water. This will medicate approximately 500 L of drinking water.
Use as the only source of water for five (5) days. If the birds have not fully responded, continue the medication for two (2) more days.
Note: One (1) teaspoonful equals 4 g.
Precaution(s): Protect from excessive heat and moisture.
Caution(s): Do not use solutions that are more than three days old.
For veterinary use only.
Warning(s): Treated animals must not be slaughtered for use as food for at least 24 hours after the last treatment with this drug. Do not use in birds producing eggs for food purposes.
Presentation: 100 g pouches.
Disclaimer: Every effort has been made to ensure the accuracy of the information published. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the product label or package insert. Compendium Code No.: 2210110

OXYVET® 200 LA
P.V.U.
Oxytetracycline Injection
Oxytetracycline injectable solution
DIN: 02184575
Active Ingredient(s): OXYVET® 200 LA is a sterile, long-acting, stable, aqueous solution containing oxytetracycline dihydrate equivalent to 200 mg oxytetracycline base per mL.
Indications: OXYVET® 200 LA injectable solution, is indicated in the treatment of all infections caused by oxytetracycline-sensitive bacteria in cattle and swine.
Cattle: Bacterial pneumonia, pasteurellosis (associated with shipping fever complex), mastitis, metritis, calf scours (bacterial enteritis), foot rot, navel ill, calf diphtheria, leptospirosis, blackleg/malignant edema, peritonitis, joint ill.
Swine: Erysipelas, bacterial enteritis, leptospirosis, metritis, mastitis, bacterial pneumonia.
Dosage and Administration: Administer by deep intramuscular injection at a single dose rate of 1 mL per 10 kg of body weight (20 mg oxytetracycline per kg of body weight).
It is recommended that the maximum dose at any one (1) site be 20 mL in cattle and 10 mL in pigs to minimize local tissue irritation at the injection site. Intramuscular injections should be made deep into the fleshy part of a muscle such as the thigh.
Following administration, temporary localized swelling may be observed at the site of injection for several days. This is due to the high concentration and long-acting effect of the product.
OXYVET® 200 LA injectable solution, should be warmed to body temperature prior to administration.
If clinical improvement is not observed after 48 hours, clinical re-evaluation may be required. In nonresponsive cases, consideration may be given to the use of an alternative antibiotic.
Treatment with OXYVET® 200 LA injectable solution only, in severe disease cases, may be insufficient.
Precaution(s): Store below 25°C and protect from light. Do not freeze.
Caution(s): Occasional sensitivity reactions have been observed following the parenteral administration of oxytetracycline. If such side effects occur, discontinue use of the drug and administer epinephrine immediately.
Warning(s): Treated animals must not be slaughtered for use as food for at least 21 days after the last treatment with this drug.
Do not use in lactating dairy cattle.
Presentation: OXYVET® 200 LA injectable solution is available in multidose: 100 mL, 250 mL and 500 mL vials.
Disclaimer: Every effort has been made to ensure the accuracy of the information published. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the product label or package insert. Compendium Code No.: 2201047

NUFLOR®
Pr
Schering-Plough
Florfenicol
Florfenicol 300 mg/mL-Sterile Injectable Solution
DIN: 02216558
Active Ingredient(s): Each millilitre contains 300 mg florfenicol, 250 mg N-methyl-2-pyrrolidone, polyethylene glycol 300 q.s. 1.0 mL and 150 mg propylene glycol as a preservative.
Indications: NUFLOR® Injectable Solution is indicated for the treatment of bovine respiratory disease complex, also called shipping fever, associated with Pasteurella haemolytica, Pasteurella multocida and Haemophilus somnus.
Pharmacology: Description: NUFLOR® is a light yellow to straw coloured, slightly viscous solution.
Clinical Pharmacology: Florfenicol is a synthetic, broad spectrum antibiotic. In vitro and in vivo activity has been demonstrated against the most commonly isolated bacterial pathogens involved in bovine shipping fever including Pasteurella haemolytica, Pasteurella multocida and Haemophilus somnus.
Florfenicol has also shown significant in vitro activity against the following Gram negative pathogens of animals; Escherichia coli, Salmonella spp., Moraxella spp. and Klebsiella spp. Gram positive activity was shown in vitro against Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis, Streptococcus bovis, Streptococcus zooepidemicus, Staphylococcus aureus, Staphylococcus intermedius and Staphylococcus epidermidis. However, the clinical significance of this activity in cattle is not known.
The pharmacokinetic profile of florfenicol was evaluated in cattle using intravenous and intramuscular administration at the recommended dose of 20 mg/kg. Intravenous administration of florfenicol resulted in a mean peak serum concentration of 44.56 µg/mL five minutes after dosing and a mean serum concentration of 0.91 µg/mL twelve hours after dosing. The harmonic mean elimination half-life was 154 minutes and the median volume of distribution at steady state (Vd_ss) was 0.77 L/kg indicating excellent penetration of florfenicol into body tissues and fluids. The median area under the concentration vs time curve (AUC_0¥ ) was 5 403 µg/mL x minute. Intramuscular administration of florfenicol using the same dose resulted in a maximum mean serum concentration (C_max) of 3.21 µg/mL which occurred 200 minutes (T_max) after dosing. The mean concentration 24 hours after dosing was 0.77 µg/mL. Florfenicol was detectable in the serum of most animals through 60 hours after dosing with a mean concentration of 0.19 µg/mL. The median AUC_0¥ was 4 242 µg/mL x minutes and the median bioavailability was 79.8%.
Dosage and Administration: NUFLOR® Injectable Solution should be administered to cattle either by a single subcutaneous injection at a dose 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), in which case two doses with a 48 hour interval should be given. Do not inject more than 10 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.
Precaution(s): Storage: Product should be stored between 2° and 25°C (36° and 77°F).
Caution(s): 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.
Not for use in breeding cattle. The effects of florfenicol on bovine reproductive performance, pregnancy and lactation have not been assessed.
For intramuscular and subcutaneous use in beef and non-lactating dairy cattle only.
Warning(s): 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 lactating dairy cattle. Exceeding the dose level or number of recommended treatments may result in illegal residues in edible tissues. Not for human use. Keep out of the reach of children. This product contains material that can be irritating to skin and eyes. Avoid direct contact with skin, eyes and clothes. In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. Consult a physician if irritation persists. Accidental injection of this product may cause local irritation. Consult a physician immediately. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information.
Veterinary use only.
Adverse Reactions: No adverse effects were encountered during the clinical evaluation of this drug.
Presentation: NUFLOR® Injectable Solution is packaged in 50 mL, 100 mL, 250 mL and 500 mL multiple dose glass vials.
® Registered Trademark of Schering Canada Inc.
Disclaimer: Every effort has been made to ensure the accuracy of the information published. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the product label or package insert. Compendium Code No.: 2400001