Adaxio shampoo for dogs 500 ml
Treatement and control seborrhoeic dermatitis associated with Malassezia pachydermatis and/or Staphylococcus pseudintermedius / Chlorhexidine / Miconazole
Adaxio Shampoo for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Chlorhexidine digluconate 20 mg (equivalent to chlorhexidine 11.26 mg)
Miconazole nitrate 20 mg (equivalent to miconazole 17.37 mg)
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
A clear light yellow to yellow liquid.
4. CLINICAL PARTICULARS OF ADAXIO
4.1 Target species
4.2 Indications for use, specifying the target species
For the treatment and control of seborrhoeic dermatitis associated with Malassezia pachydermatis and/or Staphylococcus pseudintermedius.
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
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.
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.
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
4.9 Amounts to be administered and administration route
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
5. PHARMACOLOGICAL PROPERTIES OF ADAXIO
Pharmacotherapeutic group: dermatological, ATCvet code: QD08AC52.
5.1 Pharmacodynamic properties
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 resistance to chlorhexidine has not been reported.
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
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.
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 OF ADAXIO
6.1 List of excipients
Macrogol lauryl ether
Macrogol 120 methyl glucose dioleate
Citric acid monohydrate (for pH adjustement)
Benzoic acid (E210)
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.