1. Name of the veterinary medicinal product
PREDNIDERM
2. Qualitative and quantitative composition
One g contains:
Active substance(s):
Neomycin ....................(as sulfate) 3333.33 IU
Prednisolone ....................(as acetate) 1.34 mg
Excipient(s):
Phenylmercury nitrate .............. 0.05 mg
For the full list of excipients, see section “List of excipients”.
3. Pharmaceutical form
Emulsion for cutaneous application.
4. Clinical particulars
4.1. Target species
Equines, dogs and cats.
4.2. Indications for use, specifying the target species
In equines, dogs and cats:
- Treatment of skin conditions caused by germs sensitive to neomycin.
4.3. Contraindications
Hypersensitivity to any of the constituents, in particular to neomycin.
4.4. Special warnings for each target species
None.
4.5. Special precautions for use
i) Special precautions for use in animals
Inappropriate use of the product may increase the prevalence of bacteria resistant to neomycin.
Avoid licking the animal immediately after application of the product.
ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
It is recommended that persons administering the veterinary medicinal product to animals wear gloves.
In case of splashing in the eyes, rinse thoroughly with water.
In case of accidental ingestion, seek medical advice and show the package leaflet or the label to the physician.
People with known hypersensitivity to any of the ingredients should avoid contact with the product.
iii) Other precautions
None.
4.6. Adverse reactions (frequency and seriousness)
With prolonged use, corticosteroids such as prednisolone may cause iatrogenic hypercorticism, polyuropolydipsia (PUPD), immunosuppression, bulimia and redistribution of body fat reserves.
4.7. Use during pregnancy, lactation or lay
Studies in laboratory animals have shown embryotoxic effects of prednisolone.
Administration of corticosteroids during pregnancy is not recommended.
4.8. Drug interactions and other forms of interaction
In case of prolonged use, do not combine with non-steroidal anti-inflammatory drugs (NSAIDs).
4.9. Dosage and route of administration
External use.
Apply a small amount of emulsion to the lesions, two to three times a day depending on the severity of the case.
Repeat these applications:
- Every day for the initial treatment.
- 2 to 3 times a week for the maintenance treatment.
A gentle massage facilitates the penetration of the active ingredients. The use of gloves is recommended.
Shake well before use.
4.10. Overdose (symptoms, emergency procedures, antidotes), if necessary
In case of prolonged use, usual effects known to corticosteroids, see section "Adverse reactions".
4.11. Withdrawal period
Equines:
Meat and offal: zero days.
Milk: in the absence of MRLs for milk, do not use in females producing drinking milk, in lactation or in the dry period or in future females producing drinking milk in the 2 months preceding parturition.
5. Pharmacological properties
Pharmacotherapeutic group: local combination of a corticosteroid and an aminoglycoside antibiotic.
5.1. Pharmacodynamic properties
Neomycin is an aminoglycoside antibiotic, obtained from Streptomyces fradiae. Its spectrum of activity covers Gram-positive germs, particularly Staphylococci and less actively Streptococci, and Gram-negative germs, particularly Escherichia coli. Neomycin
binds to the 30S subunit of the bacterial ribosome, disrupting the reading of the constitutive code of messenger RNA, and ultimately bacterial protein synthesis. At high concentrations, aminoglycosides have been shown to damage the bacterial cell wall, adding bactericidal properties to the bacteriostatic properties.
Prednisolone is a synthetic steroidal anti-inflammatory drug belonging to the glucocorticoid family. It is used for its anti-inflammatory, immunosuppressive and antiallergic properties.
5.2. Pharmacokinetic characteristics
No data available.
6. Pharmaceutical particulars
6.1. List of excipients
Phenylmercury nitrate
Tristearin
Polysorbate 80
Macrogol stearate 300
Perfume 48 536
Liquid paraffin
Purified water
