Gefriderm Cutaneous Spray Solution for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Ketoconazole, Marbofloxacin, Prednisolone

Available from:

Alpha-Vet Allatgyogyaszati Kft.

ATC code:

QD07CA03

INN (International Name):

Ketoconazole, Marbofloxacin, Prednisolone

Pharmaceutical form:

Cutaneous spray, solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Antimicrobial; Anti Inflammatory

Authorization status:

Authorized

Authorization date:

2021-04-14

Summary of Product characteristics

Revised: March 2024
AN: 00428/2023 & 00483/2023
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
GEFRIDERM cutaneous spray solution for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES:
Marbofloxacin……………….…………. 1.025 mg
Ketoconazole………………………..….. 2.041 mg
Prednisolone …………………………… 0.926 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Cutaneous spray, solution
Yellowish, slightly opaque solution
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment
of
acute
superficial
dermatitis
caused
by
mixed
infections
with
_Pseudomonas _
_aeruginos_a
or
_Staphylococcus _
_pseudintermedius_
susceptible
to
marbofloxacin
and
_Malassezia _
_pachydermatis_
susceptible
to
ketoconazole.
The
indication is limited to focal skin infections (e.g. hot spots,
intertrigo, superficial
folliculitis).
4.3 CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substances
or to any of the
excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
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.
Revised: March 2024
AN: 00428/2023 & 00483/2023
Page 2 of 7
Treatment is indicated only if mixed infection with _ Pseudomonas
aerugino_sa or
_Staphylococcus pseudintermedius _and _Malassezia pachydermatis _has
been proved.
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
2
. The treatment
is 2 pumps of the application pump to each treate