Adspec Sterile Solution (Canada)

Chemical Name of Spectinomycin Sulfate Tetrahydrate:

Decahydro - 4a,7,9 - trihydroxy - 2 - methyl - 6,8 - bis(methylamino) - 4H - pyrano[2,3 - b][1,4]benzodioxin - 4 - one sulfate, tetrahydrate.

CLINICAL MICROBIOLOGY

Spectinomycin has demonstrated in vitro activity against the three major pathogenic bacteria (Mannheimia spp. [formerly known as Pasteurella haemolytica], Pasteurella multocida and Haemophilus somnus) associated with bovine respiratory disease (pneumonia, shipping fever). In vivo, spectinomycin has been demonstrated to be effective in the treatment of bovine respiratory disease associated with Mannheimia spp. and Pasteurella multocida.

Laboratory Microbiology

Spectinomycin has demonstrated in vitro activity against Actinomyces pyogenes and Mycoplasma spp. The clinical significance of this in vitro activity is not known.

Animal Safety

Cattle

In a pivotal subcutaneous target animal safety/toxicity study, spectinomycin sulfate sterile solution was administered subcutaneously at doses of 15, 45 or 75 mg/kg/day (1X, 3X or 5X the maximum daily recommended therapeutic dose) once daily for 15 days. Spectinomycin sulfate sterile solution was well tolerated for all dose groups. No animals died on study. Treatment-related findings included decreased urinary pH and random mild swelling at the injection sites. At necropsy, labeled injection sites (injected with 30 mL per site) of cattle treated on study days 8 and 15 had dark red, tan, brown, and/or dark brown areas, often with some expansion (thickening) of the subcutis; only mild discoloration remained at 15 days post injection. Microscopically, most injection sites had resolved by 15 days post injection.

Adspec Sterile Solution Indications

Adspec Sterile Solution Is Indicated For The Treatment Of Bovine Respiratory Disease (pneumonia, Shipping Fever) Associated With mannheimia spp. [formerly Known As Pasteurella Haemolytica] and pasteurella Multocida.

dosage

Adspec Sterile Solution Is To Be Administered Subcutaneously In The Neck Area Of Cattle At A Dosage Of 10 Mg Spectinomycin Per Kg Of Body Weight. Treatment Should Be Administered At 24-hour Intervals For 3 To 5 Consecutive Days. Studies Have Demonstrated That Five Days Of Treatment May Provide A Better Clinical Response Than Three Days. Selection Of Duration Of Treatment (3 To 5 Days) Should Be Based On The Recommendation Of A Veterinarian Or Through The Use Of A Clinical Response Evaluation Protocol Designed By A Veterinarian. Do Not Administer More Than 30 Ml Per Injection Site.

administration

Adspec Sterile Solution Is To Be Administered To Cattle By Subcutaneous Injection In The Triangular Area Of The Neck Ahead Of The Shoulder.

contraindications

As with all drugs, the use of ADSPEC sterile solution is contraindicated in animals previously found to be hypersensitive to the drug. In the event of a hypersensitivity reaction following the administration of this drug, immediate appropriate therapy should be instituted.

Warning

Not for human use. Keep out of reach of children. Do not use in lactating dairy cattle. Treated animals must not be slaughtered for use in food for at least 11 days after the latest treatment with this drug. Dosages administered either in excess of the recommended dose or by alternate routes may result in illegal residues in edible tissues.

Antimicrobial drugs, including spectinomycin sulfate tetrahydrate, may cause allergic reactions in some sensitized individuals. To minimize the possibility of an allergic reaction, users of antimicrobials, including spectinomycin sulfate tetrahydrate, are advised to avoid direct contact of the product with skin and mucous membranes.

Adspec Sterile Solution Caution

The safety of ADSPEC sterile solution has not been determined for cattle intended for breeding. To avoid the possibility of excessive trimming at the site of injection, do not slaughter cattle for at least 15 days after the latest treatment with this drug.

The use of ADSPEC sterile solution may result in mild swelling at the injection site of the treated animal.

Storage Conditions

Store at controlled room temperature 15°C to 30°C. Do not freeze.

How Supplied

Adspec Sterile Solution Is Available In 500 Ml Vials.

registered Trademark Of Pharmacia & Upjohn Company. Used Under Licence By pfizer Canada Inc.: Adspec

DIN 02240123

T-ERU/3

January, 2002

Nac No.