Bovocycline Pessary 2000 mg Intrauterine Tablet for Cattle

Summary of Product characteristics

                                Revised: May 2016
AN: 00189/2016
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovocycline Pessary 2000 mg intrauterine tablet for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each intrauterine tablet contains:
ACTIVE SUBSTANCE:
Tetracycline hydrochloride
2000.0 mg
(equivalent to 1848.2 mg tetracycline)
EXCIPIENTS:
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Intrauterine tablet
Yellow, oblong-shaped tablet, scored on one side. The tablet is not
divisible.
4
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For
treatment
and
prevention
of
post
parturient
disorders
in
cattle:
for
administration following dystocia, retained fetal membranes and
endometritis
caused by pathogens susceptible to tetracycline.
4.3
CONTRAINDICATIONS
Do not use in infections caused by pathogens
resistant to tetracycline.
Do not use in severe kidney and liver disorders.
Do not use in case of hypersensitivity to
tetracyclines or to any of the excipients.
4.4
SPECIAL WARNING FOR EACH TARGET SPECIES.
None.
Revised: May 2016
AN: 00189/2016
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
_Special precautions for use in animals_
The product should be used based on susceptibility testing and take
into
account official, national and regional antimicrobial policies.
_Special precautions to be taken by the person administering the
veterinary _
_medicinal product to animals_
Direct contact with the skin or the mucous membranes of the user
should be
avoided. The use of gloves is recommended when administering the
product to
avoid sensitisation. Wash your hands after handling the product.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Long-term therapy requires careful monitoring to avoid super-infection
(for
example with yeasts).
Occurrence of renal disorders is enhanced in dehydrated animals.
Tetracycline can cause damage to the liver.
Photodermatitis often occurs in areas of sparsely pigmented skin if
these are
exposed to s
                                
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