TETROXY LA INJECTION 200mg/ml Solution for injection

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 (AS OXYTETRACYCLINE DIHYDRATE)

INN (Διεθνής Όνομα):

GRANTED

Φαρμακοτεχνική μορφή:

BIMEDA ANIMAL HEALTH LIMITED

Οδός χορήγησης:

INJECTABLE SOLUTION

Θεραπευτική ομάδα:

PANCHRIS FEEDS (VETERINARY) LTD

Περίληψη προϊόντος:

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

Αρχείο Π.Χ.Π.

ΠΑΡΑΡΤΗΜΑ 1: SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
TETROXY LA INJECTION
200mg/ml Solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
Oxytetracycline
200mg/ml
Excipients
Povidone (K-17)
25.0mg/ml
N-Methylpyrrolidone
370.0mg/ml
Sodium formaldehyde sulfoxylate 2.7mg/ml
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, Sheep and Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Tetroxy L.A. is indicated in the treatment and control of diseases
caused by or
associated with organisms sensitive to Oxytetracycline in cattle,
sheep and pigs.
These include _Pasteurella_ spp., _Salmonella_ spp., _Escherichia
coli_ and _Listeria_ spp.
4.3
CONTRA-INDICATIONS
Do not use in cats, dogs, horses and donkeys.
Do not use in sheep intended to be milked for human consumption.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Prolonged use of anti-infectives may result in super infection by
non-susceptible
organisms.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of the 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 abut susceptibility
of the target
bacteria.
SPECIAL PRECAUTIONS TO BE TAKEN BY PERSON ADMINISTERING THE PRODUCT TO
ANIMALS
Wash hands after use.
1/8
Avoid contact with the eyes.
Laboratory studies in rabbits and rats with the excipient N-methyl
pyrrolidone have
shown evidence of foetotoxic effects. Women of childbearing age,
pregnant women
or women suspected of being pregnant should use the veterinary
medicinal product
with serious caution to avoid accidental self-injection.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Occasional local reaction of a transient nature may occur at the site
of injection.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
The use of Tetroxy L