Target species
Dogs
Indications for use for each target species
For the treatment of superficial infected wounds caused by bacteria susceptible to clindamycin (in particular Staphylococcus spp. and Streptococcus spp.).
For the treatment of superficial interdigital pyoderma caused by Staphylococcus pseudintermedius.
Contraindications
Do not use in cases of hypersensitivity to the active substance, to lincomycin or to any of the excipients.
Clindamycin should not be used for hamsters, guinea pigs, rabbits, chinchillas, horses or ruminants because clindamycin ingestion in those species could cause severe digestive disorders.
Special warnings
Cross-resistance has been shown between lincosamides (including clindamycin), erythromycin and other macrolides. Use of clindamycin should be carefully considered when antimicrobial susceptibility testing has shown resistance to lincosamides, erythromycin and other macrolides because its effectiveness may be reduced.
Special precautions for safe use in the target species
Oral ingestion (including licking) of the veterinary medicinal product by treated animals should be avoided.
This veterinary medicinal product may be irritating to the mucous membranes and eyes. Avoid contact with the mucous membranes and/or eyes.
Use of the veterinary medicinal product should be based on identification and susceptibility testing of the target pathogens. If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target bacteria at local/regional level.
Use of the veterinary medicinal product should be in accordance with official, national and regional antimicrobial policies.
Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to clindamycin and may decrease the effectiveness of treatment with lincosamides, erythromycin or other macrolides due to the potential for cross-resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
The active substance clindamycin, as well as the excipients polyethylene glycol and propylene glycol, may cause hypersensitivity (allergy) reactions. Skin contact with the veterinary medicinal product should be avoided. Wear gloves when applying the veterinary medicinal product. If contact occurs, wash hands or exposed skin and seek medical advice in case of hypersensitivity reactions.
This veterinary medicinal product may be irritating to the mucous membranes and/or eyes. Avoid contact with the mucous membranes and/or eyes including hand-to-eye contact. If contact occurs, rinse with clean water. If eye irritation persists, seek medical advice and show the package leaflet or label to the physician.
Special precautions for the protection of the environment
Not applicable.
Adverse events
Dog:
Undetermined frequency (cannot be estimated from the available data) | Diarrhoeaa Allergic skin reaction (e.g. pain, redness and itching) |
a Antibiotic-associated.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy:
Laboratory studies in rats and mice have not produced any evidence of teratogenic effects after oral administration.
No teratogenic effects were found in pregnant women during the second and third trimester after systemic administration of the active substance clindamycin. However, no data is available for gestating bitches.
Use only according to the benefit-risk assessment by the responsible veterinarian.
Lactation:
No data is available on safety in lactating bitches. Use only according to the benefit-risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
Antagonism occurs with β-lactam antibiotics, chloramphenicol and macrolides.
Amounts to be administered and administration route
Cutaneous use.
Carefully apply a thin layer of ointment to the area of the skin to be treated, 3 to 4 times daily to ensure the area to be treated is covered with ointment all day, until clinical resolution of all lesions.
The maximum duration of treatment for superficial, infected wounds is 7 days. For the treatment of superficial interdigital pyoderma the maximum duration of treatment is 14 days.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
When applied cutaneous, at a multiple of the recommended therapeutic dose, no direct side effects related to the use of clindamycin in dogs were observed.
After oral ingestion, due to grooming or licking, side effects such as vomiting and diarrhoea may occur, as these adverse events have been described after oral clindamycin treatment. Overdosing the amount of ointment, may increase the risk of oral ingestion.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable.