Utertab 2000 mg intrauterine tablet for cattle (pack of 10)

4.1 Target species
Cattle (lactating cow).
4.2 Indications for use, specifying the target species
For treatment and prevention of post parturient disorders in cattle: for administration
following retained foetal membranes and endometritis caused by pathogens
susceptible to tetracycline as well as after severe obstetrical procedures (fetotomy,
caesarean section).
4.3 Contraindications
Do not use in infections caused by pathogens resistant to tetracycline.
Do not use in known cases of hypersensitivity to the active substance or to any of the
excipients.
Do not use in severe kidney or liver disorders.
4.4 Special warnings for each target species
None.
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4.5 Special precautions for use
Special precautions for use in animals
Whenever possible, the product should only be used based on susceptibility testing.
Official, national and regional antimicrobial policies should be taken into account
when the product is used. Milk from treated cows should not be fed to calves up to
the end of the milk withdrawal period, except during the colostral phase, due to
potential for selection of resistance in intestinal flora of calves.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
This product may cause sensitisation. Avoid direct contact with the skin or the
mucous membranes.
Gloves should be worn when handling the veterinary medicinal product.
Wash hands after use.
4.6 Adverse reactions (frequency and seriousness)
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 intensive sunlight.
Allergic reactions are rare.
In case of allergic or anaphylactic reactions, discontinue treatment immediately.
Allergic reactions can be treated parenterally with glucocorticoids and antihistamines.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated )
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
4.7 Use during pregnancy, lactation or lay
The product is specifically for use in the post-parturition period.
4.8 Interaction with other medicinal products and other forms of interaction
There is a potential antagonism between tetracyclines and antibiotics with
bactericidal action.
4.9 Amounts to be administered and administration route
Intrauterine use.
Cows:
2 g tetracycline hydrochloride / cow / day
equivalent to 1 tablet / cow /day
Treat one to three times at intervals of 1 up to 2 days.
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4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Overdose is not expected because each tablet represents a single dose. Please refer
to section 4.6.
4.11 Withdrawal period(s)
Cattle: Meat and offal 10 days
Milk 96 hours
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Antiinfectives and antiseptics for intrauterine use,
antibacterials, tetracycline.
ATCvet code: QG51AA02.
5.1 Pharmacodynamic properties
Tetracycline (TC) is a broad spectrum antibiotic with bacteriostatic action in vivo. It
acts by inhibiting protein synthesis at the ribosomal level, predominantly by binding to
the 30S ribosomal subunits of bacteria. The spectrum includes Gram-positive and
Gram-negative, aerobic and anaerobic pathogens.
Five mechanisms of resistance, of which the first and second are most common,
have been described:
(1) Energy dependent efflux systems; (2) Ribosomal protection proteins dissociating
tetracyclines from their binding site near the ribosomal AA-tRNA docking site; (3)
Reduced uptake of tetracyclin, due to stress-induced down-regulation of the porins
through which the drug crosses the outer cell wall of the gram-negative bacteria (4)
Enzymatic inactivation- hydroxylation of carbon-11a, which disrupts the tetracyclines'
ß-keto-enol involved in ribosome binding; (5) Ribosomal 16S RNA mutation at the
primary binding site of tetracyclines. Different tetracycline resistance (tet) genes have
been characterized, whereby majority of known tet genes code for efflux pumps,
some of the tet genes code for ribosomal protection proteins. Tetracycline resistance
is usually acquired by means of plasmids or other mobile elements (e.g. conjugative
transposons).
There is usually complete cross-resistance between tetracyclines.
For systemic action against most susceptible microorganisms, in vivo serum
concentrations of 0.5 – 2 µg/ml are considered efficacious, which need to be
sustained over a sufficiently long period of time. Concentrations of more than 2 µg/ml
of tetracycline are easily obtained in lochia following intrauterine administration of the
recommended dose.
5.2 Pharmacokinetic particulars
Absorption via mucous membranes is limited due to the amphotheric character of the
molecule. Tetracycline is distributed unequally in the organism. The highest
concentrations are reached in liver and kidney. Tetracycline is stored in calcifying
tissues.
Tetracycline undergoes enterohepatic circulation and its antimicrobially active form is
eliminated mainly via urine, faeces and milk. The biological half-life varies depending
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on the route of administration; it is prolonged in neonates and animals with renal
insufficiency.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Cellulose, microcrystalline
Maize starch
Starch, pregelatinised
Povidone K25
Silica colloidal anhydrous
Magnesium stearate
6.2 Major Incompatibilities
Not applicable.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
White opaque PVC-PE-PVdC blister sealed with Aluminium foil containing 5 tablets.
Pack sizes:
Cardboard box of 2, 4, 10, 20, 40, 60, 80, 100 blisters of 5 intrauterine tablets.
Corresponding to pack sizes of 10, 20, 50, 100, 200, 300, 400 and 500 intrauterine
tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal
product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such
veterinary medicinal product should be disposed of in accordance with local
requirements.