OXTRA 10%, 92.7mg/ml, solution for injection for cattle, horses, swine, sheep.

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Κυπριακή Δημοκρατία, Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος, Κτηνιατρικές Υπηρεσίες

Δραστική ουσία:

GRANTED

Διαθέσιμο από:

QJ01AA06

Φαρμακολογική κατηγορία (ATC):

OXYTETRACYCLINE HYDROCHLORIDE 100 MG/ML (92.7 MG/ML OXYTETRACYCLINE)

INN (Διεθνής Όνομα):

GRANTED

Φαρμακοτεχνική μορφή:

FATRO SpA ITALY

Οδός χορήγησης:

SOLUTION FOR INJECTION

Θεραπευτική ομάδα:

N. A. CHANCE TRADING CO

Περίληψη προϊόντος:

Withdrawal period: HORSES CATTLE SHEEP PIGS; Distributor: ANTIBACTERIALS FOR SYSTEMIC USE

Αρχείο Π.Χ.Π.

ΠΑΡΑΡΤΗΜΑ 1: ΠΕΡΙΛΗΨΗ ΤΩΝ
ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
OXTRA10%, 92.7mg/ml, solution for injection for cattle, horses, swine,
sheep.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
oxytetracycline……………………………………92.7 mg
(equivalent to oxytetracycline hydrochloride……100 mg)
EXCIPIENTS:
sodium formaldehyde sulphoxylate………….……….4 mg
For a full list of the excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Cattle, horses, swine, sheep.
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cattle, horses, swine and sheep ,infections caused by Gram-positive
bacteria
(_Actinomyces_
spp.,
_Arcanobacterium _
_pyogenes,Bacillus_
_anthracis, Clostridium _spp,_Corynebacterium_ spp., _Staphylococcus_
spp.,
_Streptococcus_ spp., ) Gram-negative bacteria (_Aerobacter
aerogenes,_
_Bortedella spp, Brucella spp. , E.coli, Haemophilus spp., Klebsiella
spp.,_
_Pasteurella spp., Proteus spp., Pseudomonas spp., Salmonella spp.,_
_Shigella spp., )_
_ _Spirochetes, Chlamydiae,Mycoplasmas, Rickettsiae,
Protozoa and Leptospirae sensitive to oxytetracycline_. _
More specifically:

bronchopulmonary infections (bronchitis, bronchopneumonia);

gastro-intestinal infections (enteritis, gastroenteritis);

mammary infections (acute parenchymatous mastitis);
1/15

traumatic reticuloperitonitis, metritis and metroperitonitis,
phlegmons,
infected wounds, purulent lesions.
4.3.
CONTRAINDICATIONS
Do not use in case of known hypersensitivity to oxytetracycline or any
of
the excipients.
Do not use if resistance to the tetracyclines has been found in the
breeding establishment, owing to potential cross-resistance.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Use is not permitted in horses producing milk for human consumption.
Owing to possible variations, over time
and geographically, in the
sensitivity of