Malaseb Antifungal Shampoo Dogs & Cats, 250 ml

MALASEB SHAMPOO 250 ML.

Malaseb shampoo for dogs and cats.

STATEMENT OF ACTIVE SUBSTANCES AND OTHER INGREDIENTS
Each ml contains:

Active substances:
Chlorhexidine digluconate 20 mg,
(equivalent to 11.26 mg chlorhexidine).
Miconazole nitrate 20 mg,
(equivalent to 17.37 mg miconazole).

Excipients:
Methylchloroisothiazolinone 0.0075 mg,
Methylisothiazolinone 0.0025 mg,
Sodium benzoate 1.25 mg. 
The product is a transparent to slightly cloudy liquid, light yellow to light brown.

INDICATIONS
For the treatment and control of seborrheic dermatitis associated with Malassezia pachydermatis and Staphylococcus intermedius in dogs.
As an adjuvant in the treatment of dermatophytosis caused by Microsporum canis in cats in combination with griseofulvin.

CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substances, adjuvants or any of the excipients.

ADVERSE REACTIONS
Exceptionally, a dog with atopy or a cat with an allergic skin disease may develop pruritus and/or an erythematous reaction after treatment.
In very rare cases, dogs and cats may develop a skin reaction (itching, redness) after treatment.
If you notice serious reactions or other effects not mentioned in this leaflet, please inform your veterinarian.

TARGET SPECIES
Dogs and cats.

DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Dog: As a general rule, shampoo twice a week until symptoms disappear and then weekly or as often as necessary to keep the condition under control as directed by to the veterinarian.
Cat : Apply the shampoo twice a week for a minimum period as directed by the veterinarian or until the samples are negative for M. canis culture.
The maximum duration of the treatment period must not exceed 16 weeks.
It is recommended to consult the veterinarian regarding the need to trim the cat's fur before administering the treatment.

RECOMMENDATIONS REGARDING CORRECT ADMINISTRATION
Wet the animal with plenty of clean water. Apply Malaseb shampoo to the animal in several points and massage until it penetrates the fur, especially around the lips, under the tail and between the toes. Use enough to create a lather. The animal must stand for 10 minutes. Then rinse with clean water and allow to dry naturally in a warm, draft-free place.
The 250 ml bottle provides approximately 8-16 treatments for a 15 kg dog, or 5-10 treatments for a 25 kg dog, or 25 treatments for a cat, depending on the thickness of the coat.

SPECIAL STORAGE PRECAUTIONS
Keep out of reach of children.
Do not store above 30°C.
Do not refrigerate or freeze.
Do not use after the expiry date marked on the label.
Shelf life after first opening the bottle 3 months.

SPECIAL WARNINGS
Malaseb shampoo should only be used in combination with griseofulvin in the treatment of dermatophytosis. In initially shampooed cats, brushing, through the resulting cultures, may initially lead to the reappearance of M. canis.

Dogs and cats:
To prevent the recurrence of the infection, preventive measures must be taken on the environment (cleaning and disinfection of cages, beds).

For external use only.
Official, national and regional antimicrobial measures must be respected when using the product.

Special precautions for use in animals:
In case of accidental contact with the eyes, rinse with plenty of water.
Do not allow the pet to lick during shampooing and rinsing or before drying. Take the necessary precautions so that the animal does not inhale the product or that it does not come into contact with the animal's nose or mouth during application.
Puppies should not come into contact with lactating females after treatment until the coat has dried.
Cats : Both field and experimental studies have demonstrated that M. canis contamination from the environment can be eliminated or reduced by using Malaseb shampoo twice a week. In these studies, griseofulvin was administered continuously throughout the treatment period, with both clinical improvement and a reduction in environmental contamination compared to griseofulvin alone.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of hypersensitivity to chlorhexidine, miconazole or any other excipient, handle the product with care. This product may cause eye irritation.
In case of accidental contact with the eyes, rinse with plenty of water. If irritation persists, consult a doctor immediately. Avoid excessive movement and petting of animals immediately after treatment. Avoid contact with eyes.
Dermatophytosis that occurs in cats is transmissible to humans. It is recommended to use gloves and cover your arms when clipping and shampooing an infected cat.
When applying the shampoo to the cat, to avoid prolonged contact with the shampoo, wash and dry your hands gently.
Do not rub!

Pregnancy:
Malaseb shampoo in association with griseofulvin should not be used in pregnant cats because griseofulvin is contraindicated during pregnancy.

SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED PRODUCT OR WASTE, AS APPLICABLE
Any unused product or waste from the use of such products must be disposed of in accordance with national requirements.

OTHER INFORMATION
Nature and composition of the primary packaging: 250 ml polyethylene bottle with a polypropylene screw cap.
It is issued only on the basis of a veterinary prescription.
For information about this veterinary medicinal product, please contact the local representative of the marketing authorization holder.