Gefriderm Cutaneous Spray Solution for Dogs

Bacterial and fungal dermatitis is often secondary in nature and appropriate diagnosis
should be used to determine the primary factors involved. The unnecessary use of any
pharmacologically active substance should be avoided.
Treatment is indicated only if mixed infection with
Staphylococcus pseudintermedius
If one of the pharmacologically active substances is no longer indicated due to the
different characteristics of bacterial and fungal infections, the application of
pharmacologically active substance should be discontinued and replaced by an
appropriate treatment option.
The indication is limited to focal skin infections not exceeding 25 cm
. The treatment
is 2 pumps of the application pump to each treated animal when the affected area is
under 25 cm
, and above this value the treated area has to be partitioned 25 cm
zones, maximum 4 treatment areas at the same time. Cross-resistance has been
shown between quinolones. The product should not be used when antimicrobial
susceptibility testing has shown resistance to quinolones because its effectiveness
may be reduced.

Special precautions for use in animals
Animals should be prevented from licking the application site (e.g., by the fixation of a
collar). Keep the animals to be treated separated from each other in order to prevent
licking each other. Use of the veterinary medicinal product should be based on
identification of infecting organisms and susceptibility testing.
Fluoroquinolones should be reserved for the treatment of clinical conditions which
have responded poorly, or are expected to respond poorly to other classes of
antimicrobials. However, microbiological diagnosis and susceptibility test must be
performed. Official and local antimicrobial policies should be taken into account when
the product is used.
Use of the product deviating from the instructions given in the SPC may increase the
prevalence of bacteria resistant to the fluoroquinolones and may reduce effectiveness
of treatment with other quinolones due to the potential for cross-resistance. Heavy
reliance on a single class of antibiotic may result in the induction of resistance in a
bacterial population.
Direct contact of product with eyes must be avoided.
If hypersensitivity to any of the active components occurs, treatment should be
discontinued and appropriate therapy should be initiated.
Prolonged and intensive use of topical corticosteroids preparation is known to trigger
local and systemic effects, including suppression of adrenal function, thinning of the
epidermis and delayed healing.
Spraying on open lesions and wounds must be avoided.
During the administration do not bath or shampoo the animal.
The hair coat should be kept short during treatment to assist optimal contact of
antimicrobial agents with the skin surface. Use only on altered parts of skin.

Revised: January 2025
AN: 02284/2024 + 02940/2024
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
This product may be harmful to children after accidental ingestion (gastrointestinal
disturbances, insomnia, and restlessness). Do not leave the bottle out of its child
resistant container except when applying the product to the animal. The bottle must
be closed and placed in the child resistant container immediately after application
and kept in a safe place out of the sight and reach of the children.
In case of accidental ingestion, seek medical advice immediately and show the
package leaflet or the label to the physician.
Ketoconazole and prednisolone may affect the unborn child and negatively influence
male reproductive functions. Excessive exposure to the product may lead to foetal
defects, or reduced sperm viability. The product should not be administered by
pregnant women, or those trying to conceive.
Marbofloxacin, ketoconazole and prednisolone may cause hypersensitivity (allergy)
reactions. People with known hypersensitivity to (fluoro)quinolones, ketoconazole,
prednisolone, or DMSO should avoid contact with the product.
This product may be irritating to skin and mucosal membranes. Avoid contact with the
skin including hand–to–mouth contact. Wear single-use impermeable gloves when
handling and administering the product. If contact occurs, wash hands or the exposed
area thoroughly with clean water.
Seek medical advice in case of hypersensitivity reactions or if irritation persists.
Swelling of face, lip and eyes, or respiratory difficulties are more serious signs that
need urgent medical action.
This product may be irritating to the eyes. Avoid contact with the eyes including hand-
to eye contact. If contact occurs, rinse with clean water. If eye irritation persists, seek
medical advice and show the package leaflet or label to the physician.
This product may be harmful after inhalation. Spray animals in the open air or in well-
ventilated area. Avoid breathing in the spray-mist.
Do not smoke, drink or eat while handling the product.
Flammable solution. Do not spray on naked flame or any incandescent material.
Avoid prolonged contact with the treated animals. Treated animals should not be
handled and children should not be allowed to play with treated animals until the
application site is dry (at least 20 minutes). It is therefore recommended that animals
are not treated during the day, but should be treated during the early morning and
evening.
Treated animals should not be allowed to sleep with owners, especially children.
Treated areas should not be touched during the treatment period; any fur, or other
areas that do not require this treatment, that may have been sprayed, should be
thoroughly cleaned using a disinfectant wipe to prevent contamination. Any wipes and
gloves used should be disposed of immediately.