Adaxio Shampoo for Dogs

Composition

Each ml contains:

Active substances:

Chlorhexidine digluconate 20 mg (equivalent to chlorhexidine 11.26 mg)

Miconazole nitrate 20 mg (equivalent to miconazole 17.37 mg)

Excipients:

Methylchloroisothiazolinone 0.0075 mg

Methylisothiazolinone 0.0025 mg

Benzoic acid (E210) 1,35 mg

For the full list of excipients, see section 6.1.

6.1 List of excipients

Methylchloroisothiazolinone

Methylisothiazolinone

Benzoic acid (E210)

Macrogol lauryl ether

Cocamidopropyl betaine

Disodium cocoamphodiacetate

Cetrimonium chloride,

Macrogol 120 methyl glucose dioleate

Magnesium chloride

Sodium chloride

Magnesium nitrate

Citric acid monohydrate (for pH adjustement)

Water, purified

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Pharmaceutical form

Shampoo.

A clear light yellow to yellow liquid.

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Pharmacological properties

Pharmacotherapeutic group: dermatological, ATCvet code: QD08AC52.

5.1 Pharmacodynamic properties

Chlorhexidine digluconate Chlorhexidine digluconate (ATCvet classification QD08AC02) is a Bisbiguanide antimicrobial agent against Gram-positive and Gram-negative bacteria. It is both bactericidal and bacteriostatic depending on the concentration used. Growth inhibition is achieved by a direct effect on ATP- ase so interfering with the energy transport mechanisms. The bactericidal effect of chlorhexidine results from coagulation of the bacterial cell contents.

Chlorhexidine digluconate is incorporated in the product for its activity against Staphylococcus pseudintermedius. Typical MIC values found in clinical Staphylococcus pseudintermedius isolates are 2.0 mg/L (2015).

Staphylococcus pseudintermedius resistance to chlorhexidine has not been reported.

Miconazole nitrate Miconazole nitrate (ATCvet classification QD01AC02) is an imidazole antifungal agent with activity against yeasts such as Malassezia pachydermatis.

It is both fungicidal and fungistatic depending on the concentration used. Miconazole inhibits ergosterol incorporation into cell membranes so increasing concentrations of cytotoxic hydrogen peroxide within the fungal cell wall.

Miconazole nitrate has been incorporated in the product for its activity against Malassezia pachydermatis. Typical MIC values found in clinical Malassezia pachydermatis isolates are 1 – 4.0 µg/mL (2012). Malassezia pachydermatis resistance to miconazole has not been reported.

5.2 Pharmacokinetic particulars

Chlorhexidine digluconate High concentrations of chlorhexidine digluconate are achieved in the hair coat and on the skin for the 10 minute period following shampooing. These concentrations are well in excess of the MICs for Staphylococcus pseudintermedius. Chlorhexidine digluconate is poorly absorbed from the gastrointestinal tract on ingestion. There is little or no percutaneous absorption. In humans it has been shown that 26% remains on the skin at 29 hours after application.

Miconazole nitrate High concentrations of miconazole nitrate are achieved in the hair coat and on the skin for the 10 minute period following shampooing. These concentrations are well in excess of the MICs for Malassezia pachydermatis.

There is little absorption through skin or mucous membranes when applied topically.

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Target species

Dogs

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Indications

For the treatment and control of seborrhoeic dermatitis associated with Malassezia pachydermatis and/or Staphylococcus pseudintermedius.

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Dosage

Cutaneous use.

As a general rule, shampoo twice weekly until the symptoms subside and weekly thereafter or as necessary to keep the condition under control. Wet the animal thoroughly with clean water and apply the product to the animal at several points and massage into the coat. Use sufficient to raise a lather on the coat and skin. Ensure that the shampoo is applied around the lips, under the tail and between the toes. Allow the animal to stand for 10 minutes, then rinse off with clean water and leave to dry naturally in a warm, draught-free environment.

Number of treatments per 500 mL bottle (short hair, long hair): Up to 15kg: 33, 15; 16-24kg: 25, 13; 25kg or more: 20, 10

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Contraindications

Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

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Adverse reactions

Skin reactions such as itching and redness may occur very rarely.

Pruritic and/or erythematous reaction may appear very rarely in an atopic dog.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports)

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Warnings

i. Special precautions for use in animals

Official, national and regional antimicrobial policies should be taken into account when the product is used.

Take care to avoid the animal inhaling the product or getting it into eyes, auditory canal, nose or mouth during shampooing.

In case of accidental contact with eyes, rinse with plenty of water. If eye irritation persists, consult a veterinarian.

Do not allow the animal to lick itself during shampooing and rinsing, or before it is dried. Puppies should not come into contact with nursing females after treatment until the coat has dried.

Use of the product deviating from the SPC’s recommendations may induce a resistance in the population of skin bacteria.

ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals

• People with known hypersensitivity to chlorhexidine, miconazole or any of the excipients should avoid contact with the product.

• This product may cause hypersensitivity following dermal contact. If you develop symptoms following exposure such as skin rash, you should seek medical advice and show the physician the label or package leaflet.

• Accidental eye contact with undiluted product may cause serious eye irritation. Avoid contact with the eyes. In case of accidental contact with eyes, rinse with plenty of water. If irritation persists consult your physician.

• The product can be irritating to skin. Avoid prolonged contact with the shampoo by gently washing and drying hands.

• Avoid excessive handling and stroking of treated animals immediately following treatment.

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Use during pregnancy, lactation or lay

Studies in animals have not produced any teratogenic, foetotoxic or maternotoxic effects due to chlorhexidine or miconazole at the recommended doses. The safety of the product has not been established during pregnancy and lactation. Use only accordingly to the benefit/risk assessment by the responsible veterinarian. And see section 4.5i)

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Interactions

No data are available to evaluate interactions with other topically applied products.

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Overdose

No data available.

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Special warnings

In order to prevent recurrence of the infection, appropriate control methods should be employed in the animal’s environment (e.g. cleaning and disinfection of kennel, beds.

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Withdrawal period

Not applicable.

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Incompatibilities

None known.

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Immediate packaging

The container is a white opaque polypropylene bottle with a polypropylene flip top cap.

Bottle of 200 ml

Bottle of 500ml

Cardboard box of 1 bottle of 200 ml

Cardboard box of 1 bottle of 500 ml

Not all pack sizes may be marketed

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Storage

Do not store above 25°C.

Do not refrigerate or freeze.

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Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years

Shelf-life after first opening the immediate packaging: 3 months.

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Disposal of unused product

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

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Additional information

Vm 14966/5044

9 DATE OF FIRST AUTHORISATION

20 November 2014

10 DATE OF REVISION OF THE TEXT

October 2025

Approved: 16 October 2025

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Registration holder

Ceva Sante Animale

8 rue de Logrono

33500 Libourne

France

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