Oxytetracycline FP 10%, 100 mg/ml, solution

COMPOSITION
1 ml contains:
Active substance:
Oxytetracycline hydrochloride ………………………………………………100 mg
Excipients:
Sodium formaldehyde sulfoxylate ……………………………………………..5 mg
Magnesium chloride hexahydrate, water for injections,
monoethanolamine, propylene glycol.
INDICATIONS
Treatment of infections of the respiratory, digestive, urogenital system,
caused by germs sensitive to oxytetracycline. Cattle: actinobacillosis,
pododermatitis, pneumonia, pasteurellosis, mastitis, metritis. Sheep,
goats: infectious pododermatitis, pneumonia, mastitis. Pigs: enteritis,
erysipelas, pneumonia, the mastitis-metritis-agalactia syndrome. Cats
and dogs: respiratory, urogenital and gastrointestinal infections, sepsis.
CONTRAINDICATIONS
Do not administer to animals with severe renal and hepatic failure .
Do not administer in case of hypersensitivity to the active substance
or to any of the excipients.
ADVERSE REACTIONS
Sometimes, transient reactions may occur at the injection site.
Rarely, allergic or anaphylactic reactions may occur in animals with
hypersensitivity. Following the treatment, the urine may be darken
in color. During the process of osteogenesis, tetracyclines can cause
the yellowing of the teeth.
TARGET SPECIES
Cattle, sheep, goats, pigs, dogs, cats.
ADMINISTRATION
It is administered intramuscularly or intravenously, slowly, daily for
3 – 5 days:
Cattle: 4 – 8 ml of product/100 kg b.w., respectively 4 – 8 mg of
oxytetracycline hydrochloride/ kg b.w.
Sheep, goats, pigs: 2 – 4 ml of product/ 50 kg b.w., respectively 4 – 8
mg of oxytetracycline hydrochloride/kg b.w.
Dogs, cats: (intramuscularly) 1 ml of product/ 10 kg body weight,
respectively 10 mg oxytetracycline hydrochloride/ kg b.w.
RECOMMENDATIONS FOR PROPER ADMINISTRATION
Intravenous administration should be done slowly. In dogs and cats
intravenous administration is not recommended. In order to ensure
the proper dose, the body weight of the animals should be calculated
as accurately as possible to avoid underdosing the product.
SPECIAL PRECAUTIONS FOR USE
Intravenous administration is not recommended in dogs and cats.
Due to variability (time, geographical) in terms of susceptibility
of bacteria when using the product it is recommended to collect
bacteriological samples and perform susceptibility tests for
microorganisms isolated from diseased animals. If this is
not possible, treatment must be carried out based on local
epidemiological information (region, farm) regarding the sensitivity
of the target bacteria. Use of the product outside the instructions
in the SPC can leads to an increase in the prevalence of bacteria
resistant to the active substance and may lead to a decrease in the
effectiveness of the treatment due to the cross-resistance potential.
The use of the product will take into account official and local
antimicrobial policies.
USE IN PREGNANCY, LACTATION
It can be used during pregnancy and lactation.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS OR OTHER
FORMS OF INTERACTION
Avoid administration of oxytetracycline in combination with penicillins,
cephalosporins and aminoglycosides. Dilution is not recommended
with calcium salts because the product may precipitate.
OVERDOSE
Tetracyclines should not be overdosed due to intestinal
dysmicrobism, nephrotoxicity, side effects on calcification. The
recommended doses will be observed.
INCOMPATIBILITIES
It is not associated with corticosteroids because they mask and
spread the infection. In the absence of compatibility studies, this
veterinary medicinal product must not be mixed with other products
veterinary medicinal products.
WITHDRAWAL PERIOD
Meat and offal: cattle – 21 days, sheep, goats, pigs – 14 days. Milk:
cattle, sheep, goats – 3 days (6 milkings).
STORAGE
Store at a temperature below 25°C. Protect from light direct. Protect
from frost.

Shelf life after first opening the primary packaging: 28 days.
PRESENTATION
Bottles x 50 ml, 100 ml