Oxtra DD 100 mg/ml Solution for Injection for Cattle, Sheep, Pigs, Horses, Dogs and Cats
Active ingredient: Oxytetracycline
Form
Injection
Species
Manufacturer
Fatro S.p.A.
VMD MA No.
11557/5004
What it's used for
For the treatment of conditions caused by or associated with organisms sensitive to oxytetracycline including: Bordetella bronchiseptica Actinomyces pyogen...
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Oxtra DD 100 mg/ml Solution for Injection for Cattle, Sheep, Pigs, Horses, Dogs and Cats — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.
to oxytetracycline including:
Bordetella bronchiseptica
Actinomyces pyogenes
Erysipelothrix rhusiopathiae
Pasteurella spp
Staphylococcus spp
Streptococcus spp
Certain mycoplasma, rickettsiae, protozoa and chlamydia are also sensitive to
oxytetracycline.
The product is indicated for the treatment and control of pasteurellosis,
pneumonia, atrophic rhinitis, erysipelas, joint-ill, navel-ill, summer mastitis in cows,
ovine keratoconjunctivitis (pink-eye) and enzootic abortion in sheep.
Revised: March 2025
AN: 03867/2024
rate, or at a higher dose rate for prolonged duration of action. To avoid excessive residues
at the injection site, maximum injection volumes per injection site are applicable.
Cattle, sheep, pigs, horses: Intramuscular or intravenous use.
Dogs, cats: Subcutaneous or intramuscular use.
To ensure a correct dosage, body weight should be determined as accurately as possible
to avoid underdosing.
24 hourly dosage regimen:
Dose rate: 3 – 10 mg/kg body weight depending on age and species (see table).
The treatment may be repeated at 24 hour intervals for 3 to 5 consecutive days.
Intravenous injections must be given slowly over a period of at least one minute.
Prolonged action dosage regimen:
Dose rate: 10 or 20 mg/kg body weight depending on age and species (see table).
Route of administration: Intramuscular injection only, repeated once after 48 – 60 hours if
required.
This dosage regimen is not recommended for use in horses, dogs or cats or animals
producing milk for human consumption.
Treatment and metaphylaxis of enzootic abortion in sheep:
Dose rate: 20 mg/kg body weight administered between day 95 – 100 of gestation.
A further treatment may be given 2 – 3 weeks later.
For metaphylaxis, the presence of the disease in the group must be established
before the veterinary medicinal product is used.
Clean and disinfect the injection site before administration.
Repeat doses should be administered at different sites, and the sites massaged well after
injection.
The maximal volume to be administered per injection site is 20 mL for adult cattle and
horses, 10 mL for calves and sheep, and 5 ml for pigs. If larger volumes are required, the
injection volumes should be divided over different injection sites.
AN: 03334/2024Page 5 of 9
The 20 ml and 50 ml vials should not be broached more than 40 times; the 100 ml and 250
ml vials should not be broached more than 20 times.
The user should select the most appropriate vial size according to the target species to be
treated.
Do not use in horses during concomitant corticosteroid therapy.
AN: 03334/2024Page 2 of 9
Rare
(1 to 10 animals / 10,000 animals
treated):
Hepatic toxicosis
Blood dyscrasia
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Enteritis
a
Hypersensitivity reaction
b
Undetermined frequency
(cannot be estimated from the
available data):
Injection site reaction
c
Dental and bone discolouration
d
Photosensitivity
Delayed healing or bone growth
e
a
In horses alterations to intestinal flora can occur after high dose intravenous
administrations.
b
May require appropriate symptomatic treatment.
c
Slight and transient.
d
Can cause a yellow, brown or grey discolouration of bones and teeth in young animals.
e
At high dose or following chronic administration.
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.
Special precautions for safe use in the target species:
Use of the veterinary medicinal product should be based on identification and susceptibility
testing of target pathogen. If this is not possible, therapy should be based on
epidemiological information and knowledge of susceptibility of the target pathogens at farm
level, or at local/regional level.
Use of the veterinary medicinal product should be in accordance with official, national and
regional antimicrobial policies.
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.
The veterinary medicinal product should be used cautiously in animals with hepatic or
renal impairment.
Use with caution in horses with gastro-intestinal disturbances or under stress.
See 3.7 before use in male animals.
Do not dilute the veterinary medicinal product.
If concurrent treatment is administered, use a separate injection site.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
This veterinary medicinal product may cause sensitisation, skin and eye irritation.
People with known hypersensitivity to tetracyclines, such as oxytetracycline, should avoid
contact with the veterinary medicinal product.
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.
Special precautions for the protection of the environment:
Not applicable.
AN: 03334/2024Page 3 of 9
such as penicillins and cephalosporins. Divalent or trivalent cations (Mg, Fe, Al, Ca) can
chelate tetracyclines.
AN: 03334/2024Page 4 of 9
i.m. use i.v. use
Cattle:
Meat and offal 35 days 35 days
Milk 72 hours 72 hours
Sheep:
Meat and offal 53 days 53 days
Milk 120 hours 120 hours
Pigs:
Meat and offal 14 days 14 days
Horses:
Meat and offal 6 months 6 months
Not authorised for use in horses producing milk for human consumption.
24 hourly doseProlonged action dose
Animal
Body
weight
(kg)
Dose
(mg/kg)
Volume
(ml)
Dose
(mg/kg)
Volume
(ml)
Horse500525Not recommended-Foal1001010Not recommended-Cow5003151050Calf100882020Sow/boar15057.51015Pig2582205Sheep50842010Lamb2582205Dog10101Not recommended-Cat5100.5Not recommended-
AN: 03334/2024Page 6 of 9
Prolonged action dosage regimen
i.m. use
Cattle:
Meat and offal 35 days
Sheep:
Meat and offal 18 days
Pigs:
Meat and offal 13 days
The prolonged dosage regimen is not authorised for use in animals producing milk for
human consumption.
4.
This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.
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