ANADA Number: 200-460

Tetroxy® Aquatic

Cross Vetpharm Group Ltd.

Broomhill rd.

Tallaght, Dublin,    24
IRELAND

Oxytetracycline Hydrochloride

Fish, finfish, fry and fingerlings

Immersion

Liquid (solution)

Powder

OTC

Finfish fry and fingerlings: not needed beyond the grow-out period.

520.1660d Oxytetracycline hydrochloride soluble powder.

Specifications: Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 2.46 and 9.87 ounce; pail: 3.09 pound). Each gram of powder contains 366 milligrams (mg) of oxytetracycline hydrochloride.

Conditions of use:

Finfish

Amount: Immerse fish in a solution containing 200 to 700 mg oxytetracycline hydrochloride (buffered) per liter of water for 2 to 6 hours.

Indications: For skeletal marking of finfish fry and fingerlings.

Beef cattle, dairy cattle, calves, swine, sheep, chickens, turkeys, finfish and lobster. Tolerances are established for the sum of residues of the tetracyclines including chlortetracycline, oxytetracycline, and tetracycline, in tissues and milk as follows: a. 2 parts per million (ppm) in muscle b. 6 ppm in liver c. 12 ppm in fat and kidney d. 0.3 ppm in milk.

ANADA Number: 200-452

Oxytet 100

Norbrook Laboratories Ltd.

Station Works

Newry,    BT35 6JP
Northern Ireland

Oxytetracycline Hydrochloride

Cattle, dairy, not lactating

Cattle, beef

Cattle, dairy, calves

Intravenous

Liquid (solution)

Liquid (solution)

OTC

Cattle: 22 days before slaughter.

522.1662a Oxytetracycline hydrochloride injection.

Specifications: Each milliliter of sterile solution contains 100 milligrams of oxytetracycline hydrochloride.

Conditions of use:

Cattle (beef cattle, beef calves, nonlactating dairy, dairy calves)

Amount: 3 to 5 milligrams of oxytetracycline hydrochloride per pound of body weight per day; 5 milligrams per pound of body weight per day for treatment of severe forms of the indicated diseases. Administer 100-milligram-per-milliliter solution intravenously.

Indications: The drug is used for treatment of bacterial pneumonia and shipping fever complex associated with Pasteurella species; foot-rot and calf diphtheria caused by Fusobacterium necrophorum; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresi; wound infections, acute metritis, and traumatic injury caused by staphylococcal and streptococcal organisms.

Limitations: Continue treatment 24 to 48 hours following remission of disease symptoms, not to exceed a total of 4 consecutive days. If no improvement is noted within 24 to 48 hours, consult a veterinarian for diagnosis and therapy. Discontinue treatment at least 22 days before slaughter. Not for use in lactating dairy animals.

Beef cattle, dairy cattle, calves, swine, sheep, chickens, turkeys, finfish and lobster. Tolerances are established for the sum of residues of the tetracyclines including chlortetracycline, oxytetracycline, and tetracycline, in tissues and milk as follows: a. 2 parts per million (ppm) in muscle b. 6 ppm in liver c. 12 ppm in fat and kidney d. 0.3 ppm in milk.

ANADA Number: 200-451

HeifermaX® 500 plus Bovatec®

Ivy Laboratories, Division of Ivy Animal Health, Inc.

8857 Bond Street

Overland Park, KS    66214
USA

Lasalocid

Melengestrol Acetate

Cattle, beef, heifers fed in confinement for slaughter

Per Os

Medicated feed

Type A Medicated Article

OTC

Not required

558.342 Melengestrol acetate.

Specifications Liquid Type A article containing 500 milligrams per pound.

Conditions of use

Cattle (heifers)

Amount Melengestrol acetate, 0.25 to 0.50 milligram per head per day in combination with lasalocid (as lasalocid sodium), 100 to 360 milligrams per head per day. To attain this amount: Add at the rate of 0.5 to 2.0 pounds per head a medicated feed (liquid) containing 0.125 to 1.0 milligram of melengestrol acetate per pound to a feed containing 10 to 30 grams of lasalocid per ton; or, Add at the rate of 0.5 to 2.0 pounds per head per day a medicated feed (liquid or dry) containing 0.125 to 1.0 milligram of melengestrol acetate plus 50 to 720 milligrams of lasalocid per pound to a ration of non-medicated feed to provide 0.25 to 0.5 milligram of melengestrol acetate and 100 to 360 milligrams of lasalocid per head per day.

Indications For increased rate of weight gain improved feed efficiency, and suppression of estrus (heat).

Limitations For heifers being fed in confinement for slaughter.

Tolerances for lasolocid residues are established as follows:

1. Cattle: The tolerance for parent lasalocid (the marker residue) in liver (the target tissue) is 0.7 part per million 2. Chickens: (I) Skin with adhering fat (the target tissue). The tolerance for parent lasalocid (the marker residue) is 1.2 parts per million. (ii) Liver. The tolerance for parent lasalocid (the marker residue) is 0.4 part per million. 3. Turkeys: (I) Skin with adhering fat (the target tissue). The tolerance for parent lasalocid (the marker residue) is .4 part per million. (ii) Liver. The tolerance for parent lasalocid (the marker residue) is 0.4 part per million. 4. Rabbits: The tolerance for parent lasalocid (the marker residue) in liver (the target tissue) is 0.7 part per million. 5. Sheep: The tolerance for parent lasalocid (the marker residue) in liver (the target tissue) is 1.0 part per million

A tolerance of 25 parts per billion is established for residues of the parent compound, melengestrol acetate, in fat, of cattle.

ANADA Number: 200-448

Heifermax® plus Optaflexx® and Rumensin®

Ivy Laboratories, Division of Ivy Animal Health, Inc.

8857 Bond Street

Overland Park, KS    66214
USA

Ractopamine Hydrochloride

Melengestrol Acetate

Monensin Sodium

Cattle, beef, heifers fed in confinement for slaughter

Per Os

Type C medicated feed

Type A Medicated Article

OTC

Cattle: zero days before slaughter.

558.500 Ractopamine

Specifications:

Conditions of use:

Heifers fed in confinement for slaughter

Amount: 9.8 to 24.6 grams per ton ractopamine combined with monensin 10 to 30 grams per ton, and melengestrol acetate to provide 0.25 to 0.5 milligrams per head per day.

Indications: For prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, for increased carcass leanness, improved feed efficiency, increased rate of weight gain and for suppression of estrus (heat).

Limitations: Feed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding.

A tolerance of 0.10 part per million (ppm) in cattle liver, 0.05 ppm in muscle, kidney, and fate.

A tolerance of 0.05 ppm in goats edible tissue.

A tolerance for residue of monensin in chickens, turkeys and quail is not needed.

A tolerance for residues of monensin in milk is not needed.

The tolerance for ractopamine hydrochloride (the marker residue) in swine is 0.15 part per million) in liver (target tissue).

The tolerance for ractopamine hydrochloride (the marker residue) in cattle is 0.03 part per million in muscle and 0.09 part per million in liver.

The tolerance for ractopamine hydrochloride (the marker residue) in turkeys is 0.45 ppm in liver(target tissue) and 0.1 ppm in muscle.

A tolerance of 25 parts per billion is established for residues of the parent compound, melengestrol acetate, in fat, of cattle.

ANADA Number: 200-438

Petrem™

Minrad, Inc.

836 Main Street
2nd Floor
Buffalo, NY    14202
USA

Sevoflurane

Dog, no use class stated or implied

Inhalation

Liquid

Liquid

RX

Withdrawal times do not apply to the species listed for this product.

529.2150 Sevoflurane.

Specifications: The drug is a clear, colorless, stable liquid containing no additives or chemical stabilizers. Conditions of use: Dogs

Amount: For induction of surgical anesthesia: 5 to 7 percent sevoflurane with oxygen. For maintenance of surgical anesthesia: 3.7 to 4 percent sevoflurane with oxygen in the absence of premedication and 3.3 to 3.6 percent in the presence of premedication.

Indications for use: For induction and maintenance of general anesthesia.

Limitations: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

ANADA Number: 200-437

Noromectin®

Norbrook Laboratories Ltd.

Station Works

Newry,    BT35 6JP
Northern Ireland

Ivermectin

Bison, American

Swine, up to 70 pounds

Reindeer, no use class stated or implied

Cattle, dairy, not breeding age

Cattle, beef, excluding veal calves

Swine, no use class stated or implied

Subcutaneous

Liquid (solution)

Liquid (solution)

OTC

Cattle excluding veal: 35 days before slaughter.
Swine: 18 days before slaughter.
Reindeer: 56 days before slaughter.
Bison: 56 days before slaughter.
Milk: no withdrawal has been established.

522.1192 Invermectin injection.

Specifications: Cattle, swine, and reindeer: each milliliter of sterile aqueous solution contains 10 milligrams of ivermectin (1 percent).

Conditions of use:

Cattle, excluding veal calves

Amount: 200 micrograms per kilogram of body weight.

Indications: For the treatment and control of gastrointestinal nematodes (adults and fourth-stage larvae) (Haemonchus placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus helvetianus (adults only), N. spathiger (adults only), Bunostomum phlebotomum); lungworms (adults and fourth-stage larvae) Dictyocaulus viviparus); grubs (parasitic stages) (Hypoderma bovis, H. lineatum); sucking lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus); mites (scabies) (Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var. bovis). To control infections and to protect from reinfection with D. viviparus and O. radiatum for 28 days after treatment; O. ostertagi, T. axei, and C. punctata for 21 days after treatment; H. placei and C. oncophora for 14 days after treatment.

Limitations: Do not treat cattle within 35 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Reindeer

Amount: 10 milliliters per 50 kilograms (110 ponds) body weight subcutaneously.

Indications: It is used in reindeer for treatment and control of warbles (Oedemagena tarandi).

Limitations: For subcutaneous use only. Not for intramuscular use. Do not treat reindeer within 56 days of slaughter.

Swine

Amount: 300 micrograms per kilogram (2.2 pounds) subcutaneously.

Indications: Used in swine for treatment and control of gastrointestinal roundworms (adults and fourth-stage larvae) (large roundworm, Ascaris suum; red stomach worm, Hyostrongylus rubidus; nodular worm, Oesophagostomum species; threadworm, Strongyloides ransomi (adults only)); somatic roundworm larvae (threadworm, Strongyloides ransomi (somatic larvae)); lungworms (Metastrongylus species (adults only)); lice (Haematopinus suis); and mites (Sarcoptes scabiei var. suis).

Limitations: Do not treat swine within 18 days of slaughter.

American bison

Amount: 200 micrograms per kilogram (10 milligrams per 110 pounds) of body weight subcutaneously.

Indications: It is used in American bison for the treatment and control of grubs (Hypoderma bovis).

Limitations: For subcutaneous use. Do not slaughter within 56 days of last treatment.

A tolerance is established for 22,23-dihydroavermectin B1a (marker residue) in liver (target tissue) as follows: a. In cattle 100 parts per billion. b. In swine 20 parts per billion. c. In sheep 30 parts per billion. d. In reindeer 15 parts per billion. e. In American bison 15 parts per billion. Muscle residues are not indicative of the safety of other edible tissues. A tolerance is established for 22,23-dihydroavermectin B1a (marker residue) in muscle as follows: a. Swine 20 parts per billion b. Cattle 10 parts per billion

ANADA Number: 200-436

Normectin® Plus

Norbrook Laboratories Ltd.

Station Works

Newry,    BT35 6JP
Northern Ireland

Ivermectin

Clorsulon

Cattle, dairy, not breeding age

Cattle, beef, excluding veal calves

Subcutaneous

Liquid (solution)

Liquid (solution)

OTC

Cattle: 49 days before slaughter.

522.1193 Ivermectin and clorsulon injection.

Specifications: Each milliliter of sterile aqueous solution contains 10 milligrams (1 percent) of ivermectin and 100 milligrams (10 percent) of clorsulon.

Conditions of use:

Cattle

Amount: 1 milliliter (10 milligrams of ivermectin and 100 milligrams of clorsulon) per 50 kilograms (110 pounds). For subcutaneous use.

Indications: It is used for the treatment and control of gastrointestinal nematodes (adults and fourth-stage larvae) (Haemonchus placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus helvetianus (adults only), N. spathiger (adults only), Bunostomum phlebotomum; lungworms (adults and fourth-stage larvae) (Dictyocaulus viviparus); liver flukes (adults only) (Fasciola hepatica); grubs (parasitic stages) (Hypoderma bovis, H. lineatum); lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus); mites (Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var. bovis). It is also used to control infections of D. viviparus and O. radiatum for 28 days after treatment and O. ostertagi, T. axei and C. punctata for 21 days after treatment, and H. placei and C. oncophora, for 14 days after treatment.

Limitations: For subcutaneous use only. Not for intravenous or intramuscular use. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. Do not use in other animal species because severe adverse reactions, including fatalities in dogs, may result. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

A tolerance is established for 22,23-dihydroavermectin B1a (marker residue) in liver (target tissue) as follows: a. In cattle 100 parts per billion. b. In swine 20 parts per billion. c. In sheep 30 parts per billion. d. In reindeer 15 parts per billion. e. In American bison 15 parts per billion. Muscle residues are not indicative of the safety of other edible tissues. A tolerance is established for 22,23-dihydroavermectin B1a (marker residue) in muscle as follows: a. Swine 20 parts per billion b. Cattle 10 parts per billion

Tolerances are established for residues of clorsulon in cattle as follow:

Kidney (the target tissue): The tolerance for parent clorsulon (the marker residue) is 1.0 part per million. Muscle. The tolerance for parent clorsulon (the marker residue) is 0.1 part per million.

ANADA Number: 200-435

Respiram™

Modern Veterinary Therapeutics, LLC

1550 Madruga Ave.
Suite 329
Coral Gables, FL    33146
USA

Doxapram Hydrochloride

Cat, no use class stated or implied

Horse, no use class stated or implied

Dog, no use class stated or implied

Intravenous

Sublingual (puppies)

Subcutaneous (kittens)

Sublingual (kittens)

Subcutaneous (puppies)

Liquid (solution)

Liquid (solution)

RX

Withdrawal times do not apply to the species listed for this product.

522.775 Doxapram.

Specifications: Each milliliter of solution contains 20 milligrams (mg) doxapram hydrochloride.

Conditions of use:

Dogs

Amount: For intravenous use in dogs at a dose of 2 1/2 to 5 milligrams of doxapram hydrochloride per pound of body weight in barbiturate anesthesia, 0.5 milligrams per pound in gas anesthesia. For subcutaneous, sublingual, or umbilical vein administration in neonate puppies at a dose rate of 1 to 5 milligrams. Dosage may be repeated in 15 to 20 minutes if necessary.

Indications: Administer to dogs to stimulate respiration during and after general anesthesia; to speed awakening and return of reflexes after anesthesia. Administer to neonate dogs to initiate respiration following dystocia or caesarean section; to stimulate respiration following dystocia or caesarean section.

Limitations: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cats

Amount: For intravenous use in cats at a dose of 2 1/2 to 5 milligrams of doxapram hydrochloride per pound of body weight in barbiturate anesthesia, 0.5 milligrams per pound in gas anesthesia. For subcutaneous or sublingual use in neonate kittens at 1 to 2 milligrams. Dosage may be repeated in 15 to 20 minutes if necessary.

Indications: Administer to cats to stimulate respiration during and after general anesthesia; to speed awakening and return of reflexes after anesthesia. Administer to neonate cats to initiate respiration following dystocia or caesarean section; to stimulate respiration following dystocia or caesarean section.

Limitations: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Horses

Amount: For intravenous use in horses at 0.25 milligrams per pound of body weight in barbiturate anesthesia, 0.2 milligrams per pound in inhalation anesthesia, 0.25 milligrams per pound with chloral hydrate with or without magnesium sulfate. Dosage may be repeated in 15 to 20 minutes if necessary.

Indications: Administer to horses to stimulate respiration during and after general anesthesia; to speed awakening and return of reflexes after anesthesia.

Limitations: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

ANADA Number: 200-424

Heifermax™ / Optaflexx® / Rumensin® / Tylan®

Ivy Laboratories, Division of Ivy Animal Health, Inc.

8857 Bond Street

Overland Park, KS    66214
USA

Ractopamine Hydrochloride

Melengestrol Acetate

Monensin Sodium

Tylosin Phosphate

Cattle, heifers fed in confinement for slaughter

Per Os

Type C medicated feed

Type A Medicated Article

OTC

Cattle: zero days before slaughter.

558.500 Ractopamine

Specifications:

Conditions of use:

Heifers fed in confinement for slaughter

Amount: 9.8 to 24.6 grams per ton ractopamine combined with monensin 10 to 40 grams per ton, tylosin 8 to 10 grams per ton, and melengestrol acetate to provide 0.25 to 0.5 milligrams per head per day.

Indications: For prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; for reduction of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes, improved feed efficiency, increased rate of weight gain, for increased carcass leanness, and for suppression of estrus (heat).

Limitations: Feed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding.

Tolerances

A tolerance of 0.10 part per million (ppm) in cattle liver, 0.05 ppm in muscle, kidney, and fate.

A tolerance of 0.05 ppm in goats edible tissue.

A tolerance for residue of monensin in chickens, turkeys and quail is not needed.

A tolerance for residues of monensin in milk is not needed.

The tolerance for ractopamine hydrochloride (the marker residue) in swine is 0.15 part per million) in liver (target tissue).

The tolerance for ractopamine hydrochloride (the marker residue) in cattle is 0.03 part per million in muscle and 0.09 part per million in liver.

The tolerance for ractopamine hydrochloride (the marker residue) in turkeys is 0.45 ppm in liver(target tissue) and 0.1 ppm in muscle.

Tolerances are established for residues of tylosin in edible products of animals as follows:

a. Chickens and turkeys: 0.2 part per million (negligible residue) in uncooked fat, muscle, liver, and kidney.

b. Cattle: 0.2 part per million (negligible residue) in uncooked fat, muscle, liver, and kidney.

c. Swine: 0.2 part per million (negligible residue) in uncooked fat, muscle, liver, and kidney.

d. Milk: 0.05 part per million (negligible residue).

e. Eggs: 0.2 part per million (negligible residue).

A tolerance of 25 parts per billion is established for residues of the parent compound, melengestrol acetate, in fat, of cattle.

ANADA Number: 200-422

Heifermax 500 Liquid Premix and Rumensin®

Ivy Laboratories, Division of Ivy Animal Health, Inc.

8857 Bond Street

Overland Park, KS    66214
USA

Melengestrol Acetate

Monensin Sodium

Cattle, beef, heifers fed in confinement for slaughter

Per Os

Medicated feed

Type A Medicated Article

OTC

558.342 Melengestrol.

Specifications: Liquid Type A article containing 500 milligrams melengestrol acetate per pound.

Conditions of use:

Cattle (heifers fed in confinement for slaughter):

Amount: Melengestrol acetate 0.25 to 0.40 milligram per head per day, plus monensin (as monensin sodium), 50 to 360 milligrams per head per day.

Indications: For increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) and for the prevention and control of coccidiosis due to Eimeria bovis and E. zuernii.

Limitations: Heifers being fed in confinement for slaughter. Add at the rate of 0.5 to 2.0 pounds per head per day a medicated feed (liquid or dry) containing 0.125 to 0.80 milligram of melengestrol acetate per pound to a feed containing 5 to 30 grams of monensin per ton; or, add at the rate of 0.5 to 2.0 pounds per head per day a medicated feed (liquid or dry) containing 0.125 to 0.80 milligram of melengestrol acetate plus 25 to 720 milligrams of monensin per pound to a non-medicated feed to provide 0.25 to 0.40 milligram of melengestrol acetate and 50 to 360 milligrams of monensin per head per day or to provide 0.14 to 0.42 mg monensin/lb body weight, up to 360 mg monensin/head/day.

A tolerance of 0.10 part per million (ppm) in cattle liver, 0.05 ppm in muscle, kidney, and fate.

A tolerance of 0.05 ppm in goats edible tissue.

A tolerance for residue of monensin in chickens, turkeys and quail is not needed.

A tolerance for residues of monensin in milk is not needed.

A tolerance of 25 parts per billion is established for residues of the parent compound, melengestrol acetate, in fat, of cattle.