Denagard Injection (Canada)

Description

Denagard (tiamulin) Injection contains 10% tiamulin base in solution in oil for intramuscular administration to swine.

Chemically, tiamulin base is 14-desoxy-14-[(2-diethylaminoethyl) mercaptoacetoxy] mutilin. Its chemical structure is shown below.

Actions

Tiamulin is active against Brachyspira hyodysenteriae. The antibacterial activity of tiamulin is due to its inhibitory effects on microbial protein synthesis. Some in vitro MIC's of tiamulin from published literature are shown in the following table. Except for Brachyspira hyodysenteriae, the clinical significance of these in vitro activities is unknown.

In Vitro Susceptibility Testing:

Microorganism	MIC, mcg/mL
Brachyspira hyodysenteriae	0.0251 ≤0.10-0.202
Staphylococcus aureus ATCC 10390 ATCC 14154	0.062-0.0783 0.012-0.0153
Actinobacillus pleuropneumoniae	0.9-7.84
Mycoplasma hyopneumoniae	≤ 0.03-0.065
Mycoplasma hyorhinis	≤ 0.03-0.255
Mycoplasma hyosynoviae	0.055
Clostridium perfringens	0.625-0.783
Erysipelothrix rhusiopathiae	2.5-3.123
Pasteurella multocida	5.0-6.253
Leptospira spp.	0.07-2.56
Streptococcus suis type 2	0.25-27

Pharmacokinetics

Tiamulin base administered intramuscularly to pigs results in peak levels of antibacterial activity in the blood in approximately 2 hours. The maximum level obtained and the duration of measurable activity found following a single IM treatment is directly related to the dose administered.

Concentrations of tiamulin found in tissues of pigs dosed IM at 11 mg/kg once daily for 4 days with blood collected at slaughter 2 hours after the last dose are shown below. Concentrations are expressed as mcg/mL or mcg/g.

Toxicology

Excessive doses, e.g., 55 mg/kg or more and/or excessive duration of treatment, e.g., 33 mg/kg x 12 days, may result in death.

Adverse Reactions

In rare cases, redness of the skin primarily over the ham and underline has been observed during medication. Overdoses of Denagard have sometimes produced transitory salivation, emesis, disorientation and clonic convulsions. If signs of toxicity occur, discontinue medication immediately. Note: During treatment swine should be housed under conditions of adequate space and sanitation.

Denagard Injection Indication, Dosage And Administration

Denagard Injection is effective for treatment of swine dysentery associated with Brachyspira hyodysenteriae susceptible to tiamulin when administered intramuscularly at 11 mg tiamulin per kilogram body weight once daily until clinical signs have disappeared or for a maximum of 4 days.

Use Directions

Determine the weight of the pig to be treated and inject the correct drug dose intramuscularly using a sterile syringe and needle. Do not inject more than 10 mL at one site. Use a different site each day.

Contraindications

Swine being treated with Denagard Injection should not have access to feeds containing polyether ionophores (e.g. monensin, lasalocid, narasin, salinomycin and semduramicin) as adverse reactions may occur.

Warning

Treated animals must not be slaughtered for use in food for at least 9 days after the latest treatment with this drug.

Avoid contact with the skin.

Keep Out Of Reach Of Children.

Denagard Injection Caution

For intramuscular use in swine only. Do not overdose. This drug should not be administered to sows during 4 weeks after service.

Attention

If no response to treatment is observed within 4 days, reestablish the diagnosis. Failure of response may be related to the presence of non-susceptible organisms or other complicating disease conditions. Because of the tendency for the disease to recur on premises with a history of swine dysentery, a control program should be implemented after treatment. Drugs are not substitutes for proper sanitary measures or good management, but should be used in conjunction with such practices.

How Supplied

Storage

Store at less than 27°C. Protect from light.

Observe expiration dates.

Each mL contains: 100 mg tiamulin and 0.20 mg butylparaben (preservative).

References

1. Laber, G. 1976 Zbl. Bakt. Hyg., I. Abt. Orig. A. 236:127-130.

2. Kitai, K., M. Kashiwazaki, Y. Adachi, T. Kume and A. Arakawa. 1979 Antimicrob. Agents Chemoth. 15:392-395.

3. Drews, J., A. Georgopoulos, G. Laber, E. Schutze and J. Unger. 1975 Antimicrob. Agents Chemoth. 7:507-516.

4. Burch, D., G. Jones, T. Heard and R. Tuck. 1986 Vet. Record 119:108-112.

5. Laak, E., A. Pijpers, J. Noordergraaf, E. Schoevers and J. Verheijden. 1991 Antimicrob. Agents Chemoth. 35:228-233.

6. Laber, G. and E. Schutze. 1977 Zbl. Bakt. Hyg., I. Abt. Orig. A. 239:403-408.

7. Pijpers, A., B. Klingeren, E. Schoevers, J. Verheijden and A. Miert. 1988 Proc. 10th IPVS Congress, p. 98.

^® Registered trademark of Novartis AG; Novartis Canada Inc. registered user.

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