SUMMARY OF PRODUCT CHARACTERISTICS
AUREOZÁSYP 2% powder
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Aureozásyp 2% powder
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances:
Chlortetracycline hydrochloride 2% w/w
Benzocaine 1% w/w
3. PHARMACEUTICAL FORM
Cutaneous powder.
Pale yellow, fine powder.
4. CLINICAL PARTICULARS
4.1 Target species
Small and large animals.
4.2 Indications for use, specifying the target species
For topical administration as a dusting powder as an aid in the treatment of superficial infections. It is useful for controlling infections in wounds of small and large animals.
4.3 Contraindications
Not applicable.
4.4 Special warnings, for each target species
For external use only
4.5 Special precautions for use
(i) Special precautions for use in animals
Avoid contact between the pack and the site to be treated to minimise contamination of the remaining contents.
(ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands thoroughly after use.
Avoid breathing dust.
4.6 Adverse reactions (frequency and seriousness)
Tetracyclines can be an irritant to the tissues, but the benzocaine blocks any irritation by the product.
4.7 Use during pregnancy, lactation or lay
No particular restrictions concerning topical use of this product.
4.8 Interaction with other medicinal products and other forms of interaction
None known.
4.9 Amounts to be administered and administration route
To administer the dusting powder removes the cap and aim the opening at the site to be treated.
Squeeze sides of container firmly near the bottom.
Apply directly to the wound or infected area once daily or more frequently as the severity of the condition demands.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Chlortetracycline and benzocaine are both of low toxicity as presented in the formulation and there is a wide safety margin at recommended dosage.
4.11 Withdrawal period(s)
Meat: zero days
Milk: zero hours
5. PHARMACOLOGICAL PROPERTIES
Chlortetracycline is a broad spectrum antibiotic of the tetracycline group active against a wide range of Gram-positive and Gram-negative bacteria. The mode of action is bacteriostatic by binding irreversibly to the 30S ribosomal unit and blocking protein synthesis. When dosed orally it is absorbed into the blood stream, and is excreted in urine and faeces. When used topically it is poorly absorbed.
Benzocaine is a local analgesic acting by blocking neural impulses.
6. PHARMACEUTICAL PARTICULARS
6.1 Incompatibilities
Not applicable.
6.2 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 24 months.
6.3 Special precautions for storage
Store in a dry place
Store in tightly closed original container
Do not store above 25oC.
6.4 Nature and composition of immediate packaging
White polyethylene puffer bottle with natural polyethylene plug bearing a central orifice containing a pale yellow fine powder closed with a white ribbed screw cap. Available in packs of 6 x 35g bottles.
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.
7. MARKETING AUTHORISATION HOLDER
Cymedica s.r.o.
Hořovice
Czech Republic
8. MARKETING AUTHORISATION NUMBER(S)
96/523/96-C
96/0330/96-S
