Alamycin 100 mg/ml Solution for Injection

Summary of Product characteristics

                                Revised: October 2014
AN. 00046/2014
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Alamycin 100 mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ACTIVE SUBSTANCE_
Oxytetracycline Hydrochloride
100.0 mg/ml
_EXCIPIENTS_
Sodium Formaldehyde Sulphoxylate Dihydrate
1.5 mg/ml
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection
A clear yellow amber solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES:
Cattle
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES:
For the treatment of diseases caused by or associated with organisms
sensitive
to oxytetracycline in cattle and pigs.
4.3
CONTRAINDICATIONS:
Do not use in animals suffering from renal or hepatic damage.
Do not use in animals with known hypersensitivity to oxytetracycline
or any of
the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES:
None.
Revised: October 2014
AN. 00046/2014
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE:
i)
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
about
susceptibility of the target bacteria.
Official and local antimicrobial policies should be taken into account
when
the product is used.
Use of the product deviating from the instructions given in the SPC
may
increase the prevalence of bacteria resistant to oxytetracycline.
It is important to administer intravenous injections of the product
slowly.
ii)
Special precautions to be taken by the person administering the
product
to the animals:
Take care to avoid accidental injection. Wash hands after use. In case
of
contact with eyes or skin, wash immediately with plenty of water as
irritation may occur.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS):
General toxicity is low although collapse has been reported with
tetracyclines in
weak or debilitated animals.
Other adve
                                
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