Target species
Cattle, sheep and pigs.
Indications for use for each target species
Treatment of infections caused by oxytetracycline susceptible bacteria in cattle, sheep and pigs as follows:
Cattle:
Pasteurellosis and respiratory tract infections caused by Mannheimia haemolytica or Pasteurella multocida.
Umbilical infections and septic arthritis caused by Trueperella pyogenes, Escherichia coli or Staphylococcus aureus.
Clinical Mastitis caused by Trueperella pyogenes, Escherichia coli, Staphylococcus aureus, Streptococcus agalactiae or Streptococcus uberis.
Metritis caused by Escherichia coli.
Sheep:
Pasteurellosis and respiratory tract infections caused by Mannheimia haemolytica or Pasteurella multocida.
Umbilical infections and septic arthritis caused by Trueperella pyogenes- or Escherichia coli.
Clinical Mastitis caused by Trueperella pyogenes, Escherichia coli or Staphylococcus aureus.
Erysipelas caused by Erysipelothrix rhusiopathiae.
The veterinary medicinal product can also be used for treatment and metaphylaxis of enzootic abortion in sheep caused by Chlamydophila abortus. The presence of the disease in the group must be established before the veterinary medicinal product is used.
Pigs:
Pasteurellosis and respiratory tract infections caused by Mannheimia haemolytica or Pasteurella multocida.
Umbilical infections and septic arthritis caused by Trueperella pyogenes, Escherichia coli or Staphylococcus aureus.
Clinical Mastitis caused by Escherichia coli.
Erysipelas caused by Erysipelothrix rhusiopathiae.
Atrophic rhinitis caused by Bordetella bronchiseptica or Pasteurella multocida.
Contraindications
Do not use in horses, dogs and cats.
Do not use in animals with hepatic or renal damage.
Do not use in cases of hypersensitivity to the active substance, to other tetracyclines or to any of the excipients.
Do not use in known cases of resistance to tetracyclines.
Special warnings
None.
Special precautions for use
Special precautions for safe use in the target species:
Do not dilute the veterinary medicinal product.
If concurrent treatment is administered, use a separate injection site.
Use of the veterinary medicinal product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Official and local antimicrobial policies should be taken into account when the veterinary medicinal product is used.
Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to oxytetracycline and may decrease the effectiveness of treatment with other tetracyclines due to the potential for cross-resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This veterinary medicinal product may cause sensitisation.
People with known hypersensitivity to tetracyclines, such as oxytetracycline, should avoid contact with the veterinary medicinal product.
This veterinary medicinal product may cause skin and eye irritation.
Avoid contact of the skin and eyes with the veterinary medicinal product. In case of accidental spillage onto skin or eyes, rinse the affected area with large amounts of water.
Take care to avoid accidental injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Wash hands after use.
The excipient dimethylacetamide may damage the unborn child; therefore, women of child-bearing age must be very careful to avoid exposure via spillage onto the skin or accidental self-injection when administering the veterinary medicinal product. If you are pregnant, think you may be pregnant or are attempting to conceive, you should not administer the veterinary medicinal product.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Cattle, sheep and pigs:
Very rare (<1 animal / 10 000 animals treated, including isolated reports): | Photosensitivity1 , Hepatic disorder1,2, Blood dyscrasia1 |
Undetermined frequency (cannot be estimated from the available data) | Application site reaction3 , Discoloured bones4 , Discoloured teeth4 , Delayed bone growth5 , Delayed healing5 |
1Tetracyclines have been associated with such reactions.
2Hepatotoxicity
3Slight, transient in nature
4Oxytetracycline given to young animals can cause a yellow, brown or grey discolouration of bones and teeth.
5High dose or chronic administration may delay bone growth or healing.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
The veterinary medicinal product can be used during lactation.
The active substance, oxytetracycline, readily crosses the placenta and concentrations in the foetal blood may reach those of the maternal circulation, although the concentration is usually somewhat lower. Tetracyclines are deposited in teeth, causing discolouration, enamel hypoplasia and reduced mineralisation. Tetracyclines can also delay foetal skeletal development. As such, the veterinary medicinal product should only be used in the last half of pregnancy following risk benefit assessment by the responsible veterinarian.
Oxytetracycline is excreted in milk; concentrations are generally low.
Interaction with other medicinal products and other forms of interaction
Oxytetracycline should not be administered simultaneously with bactericidal antimicrobials, such as penicillins and cephalosporins.
Divalent or trivalent cations (Mg, Fe, Al, Ca) can chelate tetracyclines.
Administration routes and dosage
Deep intramuscular administration. The recommended dose rate is 20 mg of oxytetracycline/kg bodyweight (i.e. 1 mL of product per 10 kg bodyweight). The veterinary medicinal product is recommended for a single administration only. The cap may be safely punctured up to 35 times. When treating groups of animals, use a draw-off needle.
Maximum volume to be administered per injection site:
Cattle : 20ml
Pigs : 10ml
Sheep: 5ml
To ensure a correct dosage, body weight should be determined as accurately as possible.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Possible adverse reactions following overdose are listed . There is no known specific antidote, if signs of possible overdose occur treat the animal symptomatically.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Cattle: Meat and offal: 31 days
Milk: 10 days (240 hours)
Sheep: Meat and offal: 9 days
Milk: 7 days (168 hours)
Pigs: Meat and offal: 18 days