Microsoft word - doxyseptin january 2008
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE VETERINARY MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains: Doxycycline hyclate equivalent to 300 mg Doxycycline, 0.825mg, Titanium Dioxide (E171) and 7.181mg Ponceau 4R (E124) as colourant.
For a full list of excipients, see section 6.1
A red oblong film-coated tablet with a breaking mark, intended for oral use
Indications for use, specifying the target species
Upper respiratory tract infections and pyodermatitis caused by bacteria belonging to Staphylococcus spp.
(namely S. aureus, S. intermedius, S. epidermis
) and to Streptococcus
species, sensitive to doxycycline.
Hepatic insufficiency Not suitable for dogs less than 15 kg bodyweight
Special warnings for each target species
Special precautions for use
Special precautions for use in animals
There may be a slight risk to the oesophageal tract if the tablets are not administered with food or placed in a suitable food vehicle.
Special precautions to be taken by the person administering the veterinary medicinal product to
Wash hands thoroughly after use. Handle the tablets with care if you know you are hypersensitive
(allergic) to tetracycline. In the case of accidental ingestion, seek medical advice.
Adverse reactions (frequency and seriousness)
Vomiting, microbial superinfection of the gastro-intestinal tract and diarrhoea have been
reported as side-effects following tetracycline therapy. After exposure to intensive sunlight or
ultraviolet light photodermatitis may occur. Long term therapy may cause liver damage, and
may lead to oesophageal ulcer formation.
Use during pregnancy, lactation or lay
Interaction with other medicinal products and other forms of interaction
Doxycycline has a lower affinity to bivalent and trivalent cations than the older tetracyclines.
With the exception of Fe3+ and Fe2+ the bioavailability is not significantly impaired by
concomitant administration of metal cations. The half-life of doxycycline is reduced by
concurrent administration of barbiturates (pento-, pheno-amylbarbiturates), ethanol and
antiepileptic drugs (carbamazepine, diphenylhydantoin).
The concurrent administration with general anaesthesia can produce hypotension and sudden
collapse. Therefore full recovery from anaesthesia is required before administration of
Doxycycline should not be used concurrently with other antibiotics especially bactericidal drugs
such as ß-lactam antibiotics.
Amounts to be administered and administration route
10 mg/kg b.w. orally, once daily, for 5 consecutive days.
The product is unsuitable for dogs below 15 kg bodyweight
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
There is no specific information relating to overdosage. The recommended posology should be followed.
4.11 Withdrawal period(s)
Like all the other Tetracyclines, Doxycycline inhibits bacterial protein synthesis. They are broad-spectrum antibacterial active against Mycoplasma, Chlamydia
, and Rickettsia
as well as bacteria. Doxycycline is more lipophilic than the older tetracyclines and has a number of advantages. Absorption of orally administered Doxycycline is better and is less affected by milk and calcium salts. Doxycycline also penetrates better into several body compartments, notably the lung and cerebrospinal fluid. It enters the gastro-intestinal tract through the bile. The range of action comprises particularly Pasteurella spp., Bordetella bronchiseptica, Staphylococcal spp
., and Streptococci
Peak plasma levels of Doxycyclin are achieved within 2 h with the recommended dose of 10mg/kg BW once daily. A half life (t½ß) of Doxycyclin in dogs is about 12 h after oral administration. Sufficient therapeutic plasma levels are maintained for 24h.
Pharmacodynamic/pharmacokinetic principles indicate that doxycycline concentrations should be maintained above the MIC throughout the entire treatment period to optimise efficacy. The
lowest concentration expected to be maintained at the end of each treatment interval with DOXYSEPTIN (0.4 μg/g) is above the MIC50 of bacteria responsible for upper respiratory tract and skin infections in dogs, e.g. Staphylococcus spp.
and Streptococcus spp
. By contrast, the levels obtained after repeated administrations of the product at 10 mg/kg b.w., s.i.d. fail to meet the requirements for other kinds of infections, such as pneumonia or deep respiratory infections due to Pasteurella spp
List of excipients
Other substances Lactose Monohydrate Maize Starch Microcrystalline Cellulose Hydroxyethyl Methyl Cellulose Silica Colloidal Anhydrous Magnesium Stearate Water Purified Film coat Titanium Dioxide Ponceau 4R Lake Talc Propylene Glycol Polyethylene Glycol Eudragit Isopropyl Alcohol Acetone
Shelf life of the veterinary medicinal product as packaged for sale 2 years.
6.4. Special precautions for storage
Do not store above 25°C. Store in a dry place
6.5 Nature and composition of immediate packaging
Base layer foil of PVC/PVdC, a push through foil of aluminium. Each blister strip contains 10 tablets Folding carton with:
20 tablets 100 tablets 250 tablets 500 tablets
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 products should be disposed of in accordance with local requirements.
MARKETING AUTHORISATION HOLDER
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATE OF REVISION OF THE TEXT
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