Tulissin 25: Product Information (Page 2 of 3)

MICROBIOLOGY

Swine Tulathromycin has demonstrated in vitro activity against A. pleuropneumoniae, P. multocida, B. bronchiseptica, H. parasuis, and M. hyopneumoniae. The MICs of tulathromycin against indicated pathogens collected from field studies were determined using methods recommended by the Clinical and Laboratory Standards Institute (CLSI, M31-A and M31-A3). MICs for H. parasuis were determined using Veterinary Fastidious Medium and were incubated up to 48 hours at 35 to 37°C in a CO2-enriched atmosphere. These values are represented in Table 3, below.

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Calves Tulathromycin has demonstrated in vitro activity against M. haemolytica, P. multocida, H. somni, and M. bovis , four pathogens associated with BRD. The MICs of tulathromycin against indicated pathogens collected from field studies using tulathromycin injection (100 mg/mL) were determined using methods recommended by the CLSI (M31-A2). These values are represented in Table 4, below.

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EFFECTIVENESS

Swine
Plasma concentrations of tulathromycin administered as tulathromycin injection (100 mg/mL) or as tulathromycin injection 25 mg/mL were demonstrated to be therapeutically equivalent (see CLINICAL PHARMACOLOGY, Comparative Bioavailability Summary). Therefore, effectiveness studies conducted with tulathromycin injection (100 mg/mL) support the effectiveness for tulathromycin injection 25 mg/mL.

In a multi-location field study to evaluate the treatment of naturally occurring SRD, 266 pigs were treated with tulathromycin injection (100 mg/mL). Responses to treatment were compared to saline-treated controls. Success was defined as a pig with normal attitude, normal respiration, and rectal temperature of < 104°F on Day 7. The treatment success rate was significantly greater (P ≤ 0.05) in tulathromycin injection 100 mg/mL-treated pigs (70.5%) compared to saline-treated pigs (46.1%). M. hyopneumoniae was isolated from 106 saline-treated and non-treated sentinel pigs in this study.

Two induced infection model studies were conducted to confirm the effectiveness of tulathromycin injection (100 mg/mL) against M. hyopneumoniae. Ten days after inoculation intranasally and intratracheally with a field strain of M. hyopneumoniae, 144 pigs were treated with either tulathromycin injection 100 mg/mL (2.5 mg/kg BW) intramuscularly or an equivalent volume of saline. Pigs were euthanized and necropsied 10 days post-treatment. The mean percentage of gross pneumonic lung lesions was statistically significantly lower (P < 0.0001) for tulathromycin injection 100 mg/mL-treated pigs than for saline-treated pigs in both studies (8.52% vs. 23.62% and 11.31% vs. 26.42%).

The effectiveness of tulathromycin injection (100 mg/mL) for the control of SRD was evaluated in a multi-location natural infection field study. When at least 15% of the study candidates showed clinical signs of SRD, all pigs were enrolled and treated with tulathromycin injection 100 mg/mL (226 pigs) or saline (227 pigs). Responses to treatment were evaluated on Day 7. Success was defined as a pig with normal attitude, normal respiration, and rectal temperature of < 104°F. The treatment success rate was significantly greater (P < 0.05) in tulathromycin injection 100 mg/mL-treated pigs compared to saline-treated pigs (59.2% vs. 41.2%).

Calves
Plasma concentrations of tulathromycin administered as tulathromycin injection (100 mg/mL) or as tulathromycin injection 25 mg/mL were demonstrated to be therapeutically equivalent (see CLINICAL PHARMACOLOGY, Comparative Bioavailability Summary). Therefore, effectiveness studies conducted with tulathromycin injection (100 mg/mL) support the effectiveness for tulathromycin injection 25 mg/mL.

BRD — In a multi-location field study, 314 calves with naturally occurring BRD were treated with tulathromycin injection (100 mg/mL). Responses to treatment were compared to saline-treated controls. A cure was defined as a calf with normal attitude/activity, normal respiration, and a rectal temperature of ≤ 104°F on Day 14. The cure rate was significantly higher (P ≤ 0.05) in tulathromycin injection 100 mg/mL-treated calves (78%) compared to saline-treated calves (24%). There were two BRD-related deaths in the tulathromycin injection 100 mg/mL-treated calves compared to nine BRD-related deaths in the saline-treated calves.

Fifty-two tulathromycin injection (100 mg/mL)-treated calves and 27 saline-treated calves from the multi-location field BRD treatment study had Mycoplasma bovis identified in cultures from pre-treatment nasopharyngeal swabs. Of the 52 tulathromycin injection 100 mg/mL-treated calves, 37 (71.2%) calves were categorized as cures and 15 (28.8%) calves were categorized as treatment failures. Of the 27 saline-treated calves, 4 (14.8%) calves were categorized as cures and 23 (85.2%) calves were treatment failures.

A Bayesian meta-analysis was conducted to compare the BRD treatment success rate in young calves (calves weighing 250 lbs or less and fed primarily a milk-based diet) treated with tulathromycin injection (100 mg/mL) to the success rate in older calves (calves weighing more than 250 lbs and fed primarily a roughage and grain-based diet) treated with tulathromycin injection 100 mg/mL. The analysis included data from four BRD treatment effectiveness studies conducted for the approval of tulathromycin injection (100 mg/mL) in the U.S. and nine contemporaneous studies conducted in Europe. The analysis showed that the BRD treatment success rate in young calves was at least as good as the BRD treatment success rate in older calves. As a result, tulathromycin injection (100 mg/mL) was considered effective for the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis in suckling calves, dairy calves, and veal calves.

Two induced infection model studies were conducted to confirm the effectiveness of tulathromycin injection (100 mg/mL) against Mycoplasma bovis. A total of 166 calves were inoculated intratracheally with field strains of Mycoplasma bovis. When calves became pyrexic and had abnormal respiration scores, they were treated with either tulathromycin injection 100 mg/mL (2.5 mg/kg BW) subcutaneously or an equivalent volume of saline. Calves were observed for signs of BRD for 14 days post-treatment, then were euthanized and necropsied. In both studies, mean lung lesion percentages were statistically significantly lower in the tulathromycin injection 100 mg/mL-treated calves compared with saline-treated calves (11.3% vs. 28.9%, P = 0.0001 and 15.0% vs. 30.7%, P < 0.0001).

ANIMAL SAFETY

Swine

Plasma concentrations of tulathromycin administered as tulathromycin injection (100 mg/mL) or as tulathromycin injection 25 mg/mL were demonstrated to be therapeutically equivalent (see CLINICAL PHARMACOLOGY, Comparative Bioavailability Summary). Therefore, systemic target animal safety studies conducted with tulathromycin injection 100 mg/mL support the systemic safety for tulathromycin injection 25 mg/mL.

Safety studies were conducted in pigs receiving a single intramuscular dose of 25 mg/kg BW, or 3 weekly intramuscular doses of 2.5, 7.5, or 12.5 mg/kg BW (both studies utilized tulathromycin injection (100 mg/mL)). In all groups, transient indications of pain after injection were seen, including restlessness and excessive vocalization. Tremors occurred briefly in one animal receiving 7.5 mg/kg BW. Discoloration and edema of injection site tissues and corresponding histopathologic changes were seen in animals at all dosages and resolved over time. No other drug-related lesions were observed macroscopically or microscopically.

Sixteen growing pigs were injected with either saline or tulathromycin injection 25 mg/mL as a single injection of 4 mL. Injection site observations included two instances of erythema in the tulathromycin injection 25 mg/mL-treated group on Day 1 post-injection. No heat, sensitivity, firmness, necrosis, drainage, or swelling was observed at any injection sites in either treatment group. The gross and microscopic findings in the tulathromycin injection 25 mg/mL-treated group were consistent with inflammatory changes induced by injections and were considered to be mild or moderate with progression to macroscopic resolution by Day 28 post-injection and microscopic resolution by Day 42 post-injection.

Calves

Plasma concentrations of tulathromycin administered as tulathromycin injection (100 mg/mL) or as tulathromycin injection 25 mg/mL were demonstrated to be therapeutically equivalent (see CLINICAL PHARMACOLOGY, Comparative Bioavailability Summary). Therefore, systemic target animal safety studies conducted with tulathromycin injection 100 mg/mL support the systemic safety for tulathromycin injection 25 mg/mL.

A safety study was conducted in feeder calves receiving tulathromycin injection (100 mg/mL) as a single subcutaneous dose of 25 mg/kg BW, or 3 weekly subcutaneous doses of 2.5, 7.5, or 12.5 mg/kg BW. In all groups, transient indications of pain after injection were seen, including head shaking and pawing at the ground. Injection site swelling, discoloration of the subcutaneous tissues at the injection site and corresponding histopathologic changes were seen in animals in all dosage groups. These lesions showed signs of resolving over time. No other drug-related lesions were observed macroscopically or microscopically.

An exploratory study was conducted in feeder calves receiving tulathromycin injection (100 mg/mL) as a single subcutaneous dose of 10, 12.5, or 15 mg/kg BW. Macroscopically, no lesions were observed. Microscopically, minimal to mild myocardial degeneration was seen in one of six calves administered 12.5 mg/kg BW and two of six calves administered
15 mg/kg BW.

A safety study was conducted in preruminant calves 13 to 27 days of age receiving tulathromycin injection (100 mg/mL) at 2.5 mg/kg BW or 7.5 mg/kg BW once subcutaneously. With the exception of minimal to mild injection site reactions, no drug-related clinical signs or other lesions were observed macroscopically or microscopically.

Sixteen growing cattle were injected with either saline (eight animals) as a single injection of 11.5 mL or tulathromycin injection 25 mg/mL (eight animals) as a single injection of either 2.5 mg/kg BW or a dose volume of 11.5 mL (whichever volume was higher). One calf in the tulathromycin injection 25 mg/mL-treated group was observed to have firmness atthe injection site for a single day. Two tulathromycin injection 25 mg/mL-treated calves exhibited injection site swelling. In one calf, the swelling resolved within 48 hours. In the other calf, the swelling was observed over a three-day period, after which the calf underwent a scheduled necropsy, preventing further injection site observations. No injection site swelling was observed in saline-treated animals. At necropsy, three of the saline-treated calves and five of the tulathromycin injection 25 mg/mL-treated calves had altered tissue present at the injection site. The gross and microscopic findings in the tulathromycin injection 25 mg/mL-treated group were consistent with inflammatory changes induced by injections, were considered to be mild to marked, and progressed to macroscopic resolution and microscopic resolution by Day 42 post-injection.

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