Introduction
Company name: Fort Dodge Animal Health
Address: Flanders Road
Hedge End
Southampton SO30 4QH
Telephone: 01489 781711
Fax: 01489 788306
Duphacycline LA
Introduction
Company name: Fort Dodge Animal Health
Address: Flanders Road
Hedge End
Southampton SO30 4QH
Telephone: 01489 781711
Fax: 01489 788306
Presentation
Aqueous solution for injection containing Oxytetracycline Dihydrate Ph.Eur. equivalent to 200 mg/ml oxytetracycline base and 4mg/ml Sodium Formaldehyde Sulphoxylate USNF (antioxidant).
Uses
Oxytetracycline is a bacteriostatic antibiotic active against a wide range of Gram-positive and Gram-negative bacteria. Following intramuscular injection peak blood levels are achieved within 4 to 8 hours for the treatment of acute infections. Blood levels then persist for at least 4 days to give prolonged activity.
Duphacycline LA is indicated for the treatment and control of diseases caused by organisms sensitive to oxytetracycline in cattle, sheep and pigs. These include Bordetella bronchiseptica, Actinomyces pyogenes, Erysipelothrix rhusiopathiae, Escherichia coli, Haemophilus somnus, Pasteurella haemolytica, Pasteurella multocida, Salmonella dublin, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus faecalis, Streptococcus pyogenes and Streptococcus uberis.
Duphacycline LA is indicated in the treatment of atrophic rhinitis caused by Bordetella bronchiseptica, Pasteurella haemolytica and Pasteurella multocida. Navel/joint ill caused by Actinomyces pyogenes E. coli and Staphylococcus aureus. Mastitis caused by Actinomyces pyogenes, E. coli, Staphylococcus aureus, Streptococcus agalactiae and Streptococcus uberis. Metritis caused by E. coli and Streptococcus pyogenes. Pasteurellosis and infections of the respiratory tract caused by Pasteurella haemolytica and Pasteurella multocida. Septicaemia caused by Salmonella dublin and Streptococcus pyogenes. Erysipelas caused by Erysipelothrix rhusiopathiae.
Dosage and administration
By deep intramuscular injection, 20 mg/kg bodyweight.
Cattle, sheep and pigs | 5 ml per 50 kg (Not more than 20 ml for cattle, 10 ml for pigs and 5 ml for sheep should be given in any one site) | |
Piglets | 1 day | 0.2 ml |
7 days | 0.3 ml | |
14 days | 0.4 ml | |
21 days | 0.5 ml | |
over 21 days | 1.0 ml/10 kg | |
Contra-indications, warnings, etc
FOR ANIMAL TREATMENT ONLY
Duphacycline LA is not recommended for use in horses, dogs and cats.
Animals must not be slaughtered for human consumption during treatment.
Cattle may be slaughtered for human consumption only after 31 days from the last treatment.
Pigs may be slaughtered for human consumption only after 18 days from the last treatment.
Sheep may be slaughtered for human consumption only after 9 days from the last treatment.
Milk for human consumption must not be taken during treatment. Milk for human consumption may only be taken from cows after 10 days from the last treatment.
Do not dilute.
Once a vial has been broached the contents should be used within 4 weeks. Discard unused material.
Duphacycline LA is well tolerated. The occasional reaction which may follow its administration is usually transient.
Not for use in animals suffering from renal or hepatic damage or known hypersensitivity.
If concurrent treatment is administered use a separate injection site.
The use of tetracycline during the period of tooth development, including late pregnancy, may lead to tooth discolouration.
Pharmaceutical precautions
Do not store above 25°C. Protect from light.
When the container is broached for the first time, using the in-use shelf life which is specified on this data sheet, the date on which any product remaining in the container should be discarded should be worked out. This discard date should be written in the space provided on the label.
Keep out of the reach of children.
Wash hands after use.
In case of contact with eyes or skin, wash immediately with water as irritation may occur.
Legal category
POM-V
Packaging Quantities
Multidose vials of 100 ml.
Further information
Duphacycline LA has been formulated to provide therapeutic levels of oxytetracycline in the blood stream for at least 4 days following a single intramuscular injection. Maximum blood levels are achieved between 4 and 8 hours making the product suitable for the treatment of acute infections.
When a vial has been broached and the contents exposed to air, the solution may darken but the potency will be unchanged.
Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.
Marketing authorisation number
Vm 01596/4160.