Rx Excenel RTU 50mg/ml, 100ml

Rx Excenel 50mg, 100ml Excenel RTU EZ Sterile Suspension is a ready to use formulation that contains the hydrochloride salt of ceftiofur, which is a broad spectrum cephalosporin antibiotic. Please be aware that Excenel RTU EZ now has a new pre-slaughter withdrawal period of four days. This treatment applies to the following species: -Beef Cattle -Dairy Cattle -Swine For intramuscular and subcutaneous use in cattle and intramuscular use in swine. This product may be used in lactating dairy cattle. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. - CAUTIONS/WARNINGS:CONTRAINDICATIONS:

As with all drugs the use of EXCENEL RTU Sterile Suspension is contraindicated in animals previously found to be hypersensitive to the drug.

WARNINGS:

NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN.

Penicillins and cephalosporins can cause allergic reactions in sensitized individuals. Topical exposures to such antimicrobials including ceftiofur may elicit mild to severe allergic reactions in some individuals. Repeated or prolonged exposure may lead to sensitization. Avoid direct contact of the product with the skin eyes mouth and clothing.

Persons with a known hypersensitivity to penicillin or cephalosporins should avoid exposure to this product.

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. If allergic reaction occurs (e.g. skin rash hives difficult breathing) seek medical attention.

The material safety data sheet contains more detailed occupational safety information. To obtain a material safety data sheet (MSDS) please call 1-800-733-5500 or to report any adverse event please call 1-888-963-8471.


RESIDUE WARNINGS:

Swine: When used according to label indications dosage and route of administration treated swine must not be slaughtered for 4 days following the last treatment. Use of dosages in excess of those indicated or by unapproved routes of administration may result in illegal residues in edible tissues.

Cattle: When used according to label indications dosage and route of administration treated cattle must not be slaughtered for 3 days following the last treatment. When used according to label indications dosage and route of administration a milk discard time is not required. Uses of dosages in excess of those indicated or by unapproved routes of administration such as intramammary may result in illegal residues in edible tissues and/or milk. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal.


PRECAUTIONS:

The effects of ceftiofur on cattle and swine reproductive performance pregnancy and lactation have not been determined.

Swine: Areas of discoloration associated with the injection site at time periods of 11 days or less may result in trim-out of edible tissues at slaughter. The safety of ceftiofur has not been demonstrated for pregnant swine or swine intended for breeding.

Cattle: Following intramuscular or subcutaneous administration in the neck areas of discoloration at the site may persist beyond 11 days resulting in trim loss of edible tissues at slaughter. Following intramuscular administration in the rear leg areas of discoloration at the injection site may persist beyond 28 days resulting in trim loss of edible tissues at slaughter. - DIRECTIONS:Shake well before using.

Swine: Administer intramuscularly at a dosage of 1.36 to 2.27 mg ceftiofur equivalents/lb (3.0 to 5.0 mg/kg) BW (1 mL of sterile suspension per 22 to 37 lb BW). Treatment should be repeated at 24 h intervals for a total of three consecutive days.

Cattle:

- For bovine respiratory disease and acute bovine interdigital necrobacillosis: administer by intramuscular or subcutaneous administration at the dosage of 0.5 to 1.0 mg ceftiofur equivalents/lb (1.1 to 2.2 mg/kg) BW (1 to 2 mL sterile suspension per 100 lb BW). Administer daily at 24 h intervals for a total of three consecutive days. Additional treatments may be administered on Days 4 and 5 for animals which do not show a satisfactory response (not recovered) after the initial three treatments. In addition for BRD only administer intramuscularly or subcutaneously 1.0 mg ceftiofur equivalents/lb (2.2 mg/kg) BW every other day on Days 1 and 3 (48 h interval). Do not inject more than 15 mL per injection site.

Selection of dosage level (0.5 to 1.0 mg/lb) and regimen/duration (daily or every other day for BRD only) should be based on an assessment of the severity of disease pathogen susceptibility and clinical response.

- For acute post-partum metritis: administer by intramuscular or subcutaneous administration at the dosage of 1.0 mg ceftiofur equivalents/lb (2.2 mg/kg) BW (2 mL sterile suspension per 100 lb BW). Administer at 24 h intervals for five consecutive days. Do not inject more than 15 mL per injection site. - INGREDIENTS:ceftiofur hydrochloride equivalent to 50 mg ceftiofur, 0.50 mg phospholipon, 1.5 mg sorbitan monooleate, 2.25 mg sterile water for injection and cottonseed oil. - MATERIAL/COMP:Liquid - STORAGE/DISPOSAL REQ:Store at controlled room temperature 20 to 25C (68 to 77F) [see USP]. Shake well before using. Protect from freezing. - HEIGHT(INCHES): 1.000 - WIDTH(INCHES):1.000 - LENGTH(INCHES):1.000

Ingredients

ceftiofur hydrochloride equivalent to 50 mg ceftiofur, 0.50 mg phospholipon, 1.5 mg sorbitan monooleate, 2.25 mg sterile water for injection, and cottonseed oil.

Dosage & Directions

Shake well before using. Swine: Administer intramuscularly at a dosage of 1.36 to 2.27 mg ceftiofur equivalents/lb (3.0 to 5.0 mg/kg) BW (1 mL of sterile suspension per 22 to 37 lb BW). Treatment should be repeated at 24 h intervals for a total of three consecutive days. Cattle: - For bovine respiratory disease and acute bovine interdigital necrobacillosis: administer by intramuscular or subcutaneous administration at the dosage of 0.5 to 1.0 mg ceftiofur equivalents/lb (1.1 to 2.2 mg/kg) BW (1 to 2 mL sterile suspension per 100 lb BW). Administer daily at 24 h intervals for a total of three consecutive days. Additional treatments may be administered on Days 4 and 5 for animals which do not show a satisfactory response (not recovered) after the initial three treatments. In addition, for BRD only, administer intramuscularly or subcutaneously 1.0 mg ceftiofur equivalents/lb (2.2 mg/kg) BW every other day on Days 1 and 3 (48 h interval). Do not inject more than 15 mL per injection site. Selection of dosage level (0.5 to 1.0 mg/lb) and regimen/duration (daily or every other day for BRD only) should be based on an assessment of the severity of disease, pathogen susceptibility and clinical response. - For acute post-partum metritis: administer by intramuscular or subcutaneous administration at the dosage of 1.0 mg ceftiofur equivalents/lb (2.2 mg/kg) BW (2 mL sterile suspension per 100 lb BW). Administer at 24 h intervals for five consecutive days. Do not inject more than 15 mL per injection site.

Cautions & Warnings

CONTRAINDICATIONS: As with all drugs, the use of EXCENEL RTU Sterile Suspension is contraindicated in animals previously found to be hypersensitive to the drug. WARNINGS: NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. Penicillins and cephalosporins can cause allergic reactions in sensitized individuals. Topical exposures to such antimicrobials, including ceftiofur, may elicit mild to severe allergic reactions in some individuals. Repeated or prolonged exposure may lead to sensitization. Avoid direct contact of the product with the skin, eyes, mouth, and clothing. Persons with a known hypersensitivity to penicillin or cephalosporins should avoid exposure to this product. 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. If allergic reaction occurs (e.g., skin rash, hives, difficult breathing), seek medical attention. The material safety data sheet contains more detailed occupational safety information. To obtain a material safety data sheet (MSDS) please call 1-800-733-5500 or to report any adverse event please call 1-888-963-8471. RESIDUE WARNINGS: Swine: When used according to label indications, dosage, and route of administration, treated swine must not be slaughtered for 4 days following the last treatment. Use of dosages in excess of those indicated or by unapproved routes of administration may result in illegal residues in edible tissues. Cattle: When used according to label indications, dosage and route of administration, treated cattle must not be slaughtered for 3 days following the last treatment. When used according to label indications, dosage and route of administration, a milk discard time is not required. Uses of dosages in excess of those indicated or by unapproved routes of administration, such as intramammary, may result in illegal residues in edible tissues and/or milk. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal. PRECAUTIONS: The effects of ceftiofur on cattle and swine reproductive performance, pregnancy, and lactation have not been determined. Swine: Areas of discoloration associated with the injection site at time periods of 11 days or less may result in trim-out of edible tissues at slaughter. The safety of ceftiofur has not been demonstrated for pregnant swine or swine intended for breeding. Cattle: Following intramuscular or subcutaneous administration in the neck, areas of discoloration at the site may persist beyond 11 days resulting in trim loss of edible tissues at slaughter. Following intramuscular administration in the rear leg, areas of discoloration at the injection site may persist beyond 28 days resulting in trim loss of edible tissues at slaughter.

Storage & Disposal

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Shake well before using. Protect from freezing.