GEFRIDERM cutaneous spray solution for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Marbofloxacin; Ketoconazole ; Prednisolone

Available from:

ALPHA-VET Állatgyógyászati Kft.

ATC code:

QD07CA03

INN (International Name):

Marbofloxacin; Ketoconazole ; Prednisolone

Dosage:

1.025, 2.041, 0.926 milligram(s)/millilitre

Pharmaceutical form:

Cutaneous spray, solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

prednisolone and antibiotics

Authorization status:

Authorised

Authorization date:

2021-04-23

Summary of Product characteristics

Health Products Regulatory Authority
23 April 2021
CRN00969Q
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
GEFRIDERM cutaneous spray solution for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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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. 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 treated animal when the affected area is under 25 cm
2
, and above this value the treated area has to be partitioned 25 c