TULAVEN: Product Information

TULAVEN- tulathromycin solution
Ceva Sante Animale

TULAVEN™ 100

(tulathromycin injection)

Injectable Solution

Antibiotic

100 mg of tulathromycin/mL

For use in beef cattle (including suckling calves), non-lactating dairy cattle (including dairy calves), veal calves, and swine. Not for use in female dairy cattle 20 months of age or older.

CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

TULAVEN™ 100 Injectable Solution is a ready-to-use sterile parenteral preparation containing tulathromycin, a semi-synthetic macrolide antibiotic of the subclass triamilide. Each mL of TULAVEN™ 100 contains 100 mg of tulathromycin, 500 mg propylene glycol, 19.2 mg citric acid and 5 mg monothioglycerol. Sodium hydroxide or hydrochloric acid may be added to adjust pH. TULAVEN™ 100 consists of an equilibrated mixture of two isomeric forms of tulathromycin in a 9:1 ratio. Structures of the isomers are shown below.

Figure 1 -- chemical structure
(click image for full-size original)

The chemical names of the isomers are (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[[2,6-dideoxy-3-C-methyl-3-O-methyl-4-C-[(propylamino) methyl]-α-L-ribo-hexopyrano-syl]oxy]-2-ethyl-3,4,10-trihydroxy-3,5,8,10,12,14-hexamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]-oxy]-1-oxa-6-azacyclopentadecan-15-oneand (2R,3R,6R,8R,9R,10S,11S,12R)-11-[[2,6-dideoxy-3-C-methyl-3-O-methyl-4-C-[(propylamino)methyl]-α-L-ribo-hexopyrano-syl]oxy]-2-[(1R,2R)-1,2-dihydroxy-1-methylbutyl]-8-hydroxy-3,6,8,10,12-pentamethyl-9-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-4-azacyclotridecan-13-one, respectively.

INDICATIONS

Beef and Non-Lactating Dairy Cattle

BRD – TULAVEN™ 100 Injectable Solution is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis ; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis.

IBK – TULAVEN™ 100 Injectable Solution is indicated for the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Rot – TULAVEN™ 100 Injectable Solution is indicated for the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Suckling Calves, Dairy Calves, and Veal Calves

BRD – TULAVEN™ 100 Injectable Solution is indicated for the treatment of BRD associated with M. haemolytica , P. multocida , H. somni , and M. bovis.

Swine

TULAVEN™ 100 Injectable Solution is indicated for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Bordetella bronchiseptica , Haemophilus parasuis , and Mycoplasma hyopneumoniae ; and for the control of SRD associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

DOSAGE AND ADMINISTRATION

Cattle: Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Table 1. TULAVEN™ 100 Cattle Dosing Guide
Animal Weight (Pounds) Dose Volume (mL)
100 1.1
200 2.3
300 3.4
400 4.5
500 5.7
600 6.8
700 8.0
800 9.1
900 10.2
1000 11.4

Swine: Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Table 2. TULAVEN™ 100 Swine Dosing Guide
Animal Weight (Pounds) Dose Volume (mL)
15 0.2
30 0.3
50 0.6
70 0.8
90 1.0
110 1.3
130 1.5
150 1.7
170 1.9
190 2.2
210 2.4
230 2.6
250 2.8
270 3.1
290 3.3

CONTRAINDICATIONS:

The use of TULAVENTM 100 Injectable Solution is contraindicated in animals previously found to be hypersensitive to the drug.

WARNINGS

FOR USE IN ANIMALS ONLY. NOT FOR HUMAN USE.

KEEP OUT OF REACH OF CHILDREN. NOT FOR USE IN CHICKENS OR TURKEYS.

RESIDUE WARNINGS
Cattle intended for human consumption must not be slaughtered within 18 days from the last treatment. This drug is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows.
Swine intended for human consumption must not be slaughtered within 5 days from the last treatment.

PRECAUTIONS

Cattle: The effects of TULAVEN™ 100 on bovine reproductive performance, pregnancy, and lactation have not been determined. Subcutaneous injection can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter.

Swine: The effects of TULAVEN™ 100 on porcine reproductive performance, pregnancy, and lactation have not been determined. Intramuscular injection can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter.

ADVERSE REACTIONS

Cattle: In one BRD field study, two calves treated with tulathromycin injection at 2.5 mg/kg BW exhibited transient hypersalivation. One of these calves also exhibited transient dyspnea, which may have been related to pneumonia.

Swine: In one field study, one out of 40 pigs treated with tulathromycin injection at 2.5 mg/kg BW exhibited mild salivation that resolved in less than four hours.

POST APPROVAL EXPERIENCE The following adverse events are based on post approval adverse drug experience reporting. Not all adverse events are reported to the FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events are listed in decreasing order of reporting frequency in cattle: Injection site reactions and anaphylaxis/anaphylactoid reactions. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://fda.gov/reportanimalae.

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