Macrosyn: Product Information (Page 3 of 4)

Swine

In vitro activity of tulathromycin has been demonstrated against Actinobacillus pleuropneumoniae , Pasteurella multocida , Bordetella bronchiseptica , Haemophilus parasuis , and Mycoplasma hyopneumoniae.

The MICs of tulathromycin against indicated SRD pathogens were determined using methods recommended by the Clinical and Laboratory Standards Institute (CLSI, M31-A and M31-A3). MICs for Haemophilus parasuis were determined using Veterinary Fastidious Medium and were incubated up to 48 hours at 35 to 37°C in a CO2 -enriched atmosphere. All MIC values were determined using the 9:1 isomer ratio of this compound. Isolates obtained in 2000 and 2002 were from lung samples from saline- treated pigs and non-treated sentinel pigs enrolled in Treatment of SRD field studies in the U.S. and Canada. Isolates obtained in 2007 and 2008 were from lung samples from saline-treated and tulathromycin injection-treated pigs enrolled in the Control of SRD field study in the U.S. and Canada. The results are shown in Table 4.

Table 4. Tulathromycin minimum inhibitory concentration (MIC) values * for indicated pathogens isolated from field studies evaluating SRD in the U.S. and Canada.

Indicated pathogen

Date isolated

No. of isolates

MIC 50
(μg/mL)

MIC 90
(μg/mL)

MIC range (μg/mL)

Actinobacillus pleuropneumoniae

2000-2002
2007-2008

135
88

16
16

32
16

16 to 32
4 to 32

Haemophilus parasuis

2000-2002

31

1

2

0.25 to > 64

Pasteurella multocida

2000-2002
2007-2008

55
40

1
1

2
2

0.5 to > 64
≤ 0.03 to 2

Bordetella bronchiseptica

2000-2002

42

4

8

2 to 8

* The correlation between in vitro susceptibility data and clinical effectiveness is unknown.

† The lowest MIC to encompass 50% and 90% of the most susceptible isolates, respectively.

EFFECTIVENESS

Cattle

BRD – In a multi-location field study, 314 calves with naturally occurring BRD were treated with tulathromycin injection. 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-treated calves (78%) compared to saline-treated calves (24%). There were two BRD-related deaths in the tulathromycin injection-treated calves compared to nine BRD-related deaths in the saline-treated calves.

Fifty-two tulathromycin injection-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-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 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. The analysis included data from four BRD treatment effectiveness studies conducted for the approval of tulathromycin injection 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 is 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.

In another multi-location field study with 399 calves at high risk of developing BRD, administration of tulathromycin injection resulted in a significantly reduced incidence of BRD (11%) compared to saline-treated calves (59%). Effectiveness evaluation was based on scored clinical signs of normal attitude/activity, normal respiration, and a rectal temperature of ≤ 104°F on Day 14. There were no BRD-related deaths in the tulathromycin injection-treated calves compared to two BRD-related deaths in the saline-treated calves. Fifty saline-treated calves classified as non-responders in this study had Mycoplasma bovis identified in cultures of post-treatment nasopharyngeal swabs or lung tissue.

Two induced infection model studies were conducted to confirm the effectiveness of tulathromycin injection 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 (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-treated calves compared with saline-treated calves (11.3% vs. 28.9%, P = 0.0001 and 15.0% vs. 30.7%, P < 0.0001).

IBK – Two field studies were conducted evaluating tulathromycin injection for the treatment of IBK associated with Moraxella bovis in 200 naturally-infected calves. The primary clinical endpoint of these studies was cure rate, defined as a calf with no clinical signs of IBK and no corneal ulcer, assessed on Days 5, 9, 13, 17, and 21. Time to improvement, defined as the first day on which a calf had no clinical signs of IBK in both eyes, provided that those scores were maintained at the next day of observation, was assessed as a secondary variable. At all time points, in both studies, the cure rate was significantly higher (P < 0.05) for tulathromycin injection-treated calves compared to saline-treated calves. Additionally, time to improvement was significantly less (P < 0.0001) in both studies for tulathromycin injection-treated calves compared to saline-treated calves.

Foot Rot — The effectiveness of tulathromycin injection for the treatment of bovine foot rot was evaluated in 170 cattle in two field studies. Cattle diagnosed with bovine foot rot were enrolled and treated with a single subcutaneous dose of tulathromycin injection (2.5 mg/kg BW) or an equivalent volume of saline. Cattle were clinically evaluated 7 days after treatment for treatment success, which was based on defined decreases in lesion, swelling, and lameness scores. In both studies, the treatment success percentage was statistically significantly higher in tulathromycin injection-treated calves compared with saline-treated calves (60% vs. 8%, P < 0.0001 and 83.3% vs. 50%, P = 0.0088).

Swine

In a multi-location field study to evaluate the treatment of naturally occurring SRD, 266 pigs were treated with tulathromycin injection. 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-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 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 (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-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 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 (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-treated pigs compared to saline-treated pigs (59.2% vs. 41.2%).

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