SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Adaxio (FR)

Adaxio Shampoo for dogs

Adaxio 20 mg/ml + 20 mg/mlShampoo for dogs (DE, AT,SE, NO, DK, FI)

2. QUALITATIVE AND QUANTITATIVE 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 a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Shampoo.

A clear light yellow to yellow liquid.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

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

4.3 Contraindications

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

4.4 Special warnings for each target species

None

4.5 Special precautions for use

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.

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.

4.6 Adverse reactions (frequency and seriousness)

Exceptionally an atopic dog may develop a pruritic and/or erythematous reaction after treatment.

In very rare circumstances, dogs may develop a skin reaction (itching, redness) after treatment.

4.7 Use during pregnancy or lactation

Studies in laboratory animals have not produced any teratogenic, foetotoxic or maternotoxic effects due to chlorhexidine or miconazole at the recommended doses. However, the safety of the product in dogs has not been investigated during pregnancy and lactation. Therefore, the product should be used in accordance with a benefit/risk assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

No data are available to evaluate interactions with other topically applied

products.

4.9 Amounts to be administered and administration route

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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No data available.

4.11 Withdrawal period

Not applicable.

5. 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 (2005). Staphylococcus pseudintermedius resistanceto 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.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Methylchloroisothiazolinone

Methylisothiazolinone

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)

Benzoic acid (E210)

Water, purified

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 21 months

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

6.4. Special precautions for storage

Do not store above 25C.

Do not refrigerate or freeze.

6.5 Nature and composition of immediate packaging

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

Bottle of 200 ml

Bottle of 500ml

Box of 1 bottle of 200 ml

Box of 1 bottle of 500 ml

Not all pack sizes may be marketed

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

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

7. MARKETING AUTHORISATION HOLDER

Ceva Animal Health Ltd

Unit 3, Anglo Office Park

White Lion Road

Amersham

Buckinghamshire

HP7 9FB

8. MARKETING AUTHORISATION NUMBER

Vm 15052/4090

9. DATE OF FIRST AUTHORISATION

20 November 2014

10. DATE OF REVISION OF THE TEXT

June 2016

16 June 2016