Phone : (639) 275-7550
E-mail : Shawn.Wilson@pahc.com
For the treatment of respiratory disease in cattle, swine and sheep.
Indications for use
Beef and Non-lactating Dairy Cattle:
Treatment of Bovine Respiratory Disease (BRD) associated with Mannheimia.
haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis. Reduction of morbidity associated with BRD in feedlot calves caused by Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis, during the first 14 days in the feedlot when administered at the time of arrival.
Treatment of Infectious Bovine Keratoconjunctivitis (IBK) associated with Moraxella bovis.
Treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.
Suckling Calves, Dairy Calves and Veal Calves BRD:
Indicated for the treatment of BRD associated with M.haemolytica, P. multocida, H somni, and M. bovis.
Treatment of SwineRespiratory Disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida and Mycoplasma hyopneumoniae and for the control of SRD caused by Actinobacillus pleuropneumoniae, Pasteurella multocida and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.
Treatment of ovine foot rot associated with Dichelobacter nodosus when systemic treatment is required due to the presence of active lesions.
Active substance: Tulathromycin 100 mg/mL
Excipient: Monothioglycerol 5 mg/mL
Cattle: Inject subcutaneously in the neck, a single dose of 2.5 mg/kg
body weight (1.25 mL/50 kg). Do not inject more than 10 mL per injection site.
Swine: inject intramuscularly in the neck, a single dose of 2.5 mg/kg body weight (0.25 mL/10 kg). Do not inject more than 2.5 mL per injection site
Sheep: Inject intramuscularly in the neck, a single dose of 2.5 mg/kg body weight (0.25 mL/10 kg)
Cattle (meat and offal): 44 days
Dairy Cows: Do not use at 20 months of age and older.
Swine: 8 days
Sheep: 16 days
If there is persistence or even aggravation of the symptoms within 2 days after the injection, it is not recommended to treat again with tulathromycin, as written in the Statistical Process Control (SPC):
For any respiratory disease, it is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 48 hours after injection. If clinical signs of respiratory disease persist or increase, or if relapse occurs, treatment should be changed using another antibiotic and continued until clinical signs have resolved.
Conversely, it remains possible to reinject TULISSIN(R) to an animal previously cured, for instance to treat another outbreak of disease. In this case, we recommend to wait at least 2 weeks between the 2 successive injections, due to the very long action of TULISSIN(R) Injection.
According to Tulissin EPAR, the environmental impact of tulathromycin is negligible (predicted environmental concentration below trigger value of 100 ppb).
A Phase I Environmental Risk Assessment (ERA) was provided according to the CVMP/VICH guidelines. The Predicted Envrionmental Concentration (PEC) for soil was calculated in accordance with VICH GL6 and the CVMP guideline on the Environmental Impact Assessment for the Veterinary Medicinal Products in support of the VICH GL6 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1).
The Environmental Risk Assessment can stop in Phase I and no Phase II assessment is required because the initial predicted environmental concentrations in soil for intensively reared animals (cattle and pigs) and pasture animals (cattle and sheep), were below the trigger value of 100 μg/kg. 1
Macrolides have immunomodulatory effects that are beneficial for humans suffering from many inflammatory pulmonary diseases. These effects have been shown for tulathromycin, as reported in TULISSIN(R) Injection SPC below:
In addition to its antimicrobial properties, tulathromycin demonstrates immune-modulating and anti-inflammatory actions in experimental studies. In both bovine and porcine polymorphonuclear cells (PMNs; neutrophils), tulathromycin promotes apoptosis (programmed cell death) and the clearance of the apoptotic cells by macrophages. It lowers the production of the pro-inflammatory mediators leukotriene B4 and CXCL-8 and induces the production of anti-inflammatory and pro-resolving lipif lipoxin A4.
Particularly regarding swine respiratory disease complex, clearance of apoptotic cells by macrophages has been shown in vitro for Actinobacillus pleuropneumoniae and immunomodulatory effects seen in PRRSv infected porcine macrophages. It is important to mention that these immunomodulatory effects do not impair normal immune response. Such non antimicrobial effects of tulathromycin are potentially interesting to treat BRD and SRD.
We chose a glass vial after observing that the stability of tulathromycin can be impaired by contact with plastic. The choice of glass guarantees an optimal quality, even at high summer temperatures, as shown by our long shelf life, 3 years. In addition, our packaging is original, with a protective shell in silicone (a material known to absorb shocks) and an adapted shape, which considerably reduces the risk of breakage of the 250 mL bottles.
Brought to you by Phibro Animal Health Corporation
Phone : (639) 275-7550
E-mail : Shawn.Wilson@pahc.com
Phone : (519) 671-8442
E-mail : Steve.Johns@pahc.com
Quebec, Manitoba, BC
Phone : (514) 913-2430
E-mail : Annie.Pelletier@pahc.com
Phone : (519) 830-5171
E-mail : Alain.Lajeunesse@pahc.com
Phone : (519) 240-8484
E-mail : Michael.Foti@pahc.com