Alamycin LA 300 Solution for Injection 300 mg/ml

Summary of Product characteristics

                                Amended Pages: August 2022
AN: 00434/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Alamycin LA 300 Solution for Injection 300 mg/ml.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
%W/V
Oxytetracycline
30.00
(as Oxytetracycline dihydrate
32.40)
EXCIPIENTS:
Sodium Formaldehyde Sulphoxylate Anhydrous
0.40
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL
FORM
Solution for injection
Clear dark amber liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
Sheep
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of conditions caused by or associated with organisms
sensitive
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.
Amended Pages: August 2022
AN: 00434/2022
Page 2 of 6
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.
4.3
CONTRAINDICATIONS
Do not dilute the product.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Oxytetracycline therapy does not completely eliminate chlamydial
infection in the
flock.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
If concurrent treatment is administered, use a separate injection
site. Resistance
against oxytetracycline may vary.
Use of the product should be based on susceptibility testing of
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.
Inappropriate use of the product may increase the prevalence of
bacteria resistant
to
oxytetracycline
and
may
decrease
the
effectiveness
of
treatment
with
tetracyclines due to the po
                                
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