Each gram contains: Active substance:

Clindamycin (as clindamycin hydrochloride) 10 mg

Ointment. White to yellowish ointment for cutaneous use.

Dogs

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.

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.

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.

Oral ingestion (including licking) of the product by treated animals should be avoided. This product may be irritating to the mucous membranes and eyes. Avoid contact with the mucous membranes and/or eyes.

Use of the 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 product should be in accordance with official, national and regional antimicrobial policies.

Use of the product deviating from the instructions given in this datasheet 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.

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 product. If contact occurs, wash hands or exposed skin and seek medical advice in case of hypersensitivity reactions.

This 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.

Hypersensitivity reactions of the skin (e.g. pain, redness and itching) are possible. Antibiotic-associated diarrhoeas are possible.

Pregnancy: No teratogenic effects were found in studies with laboratory animals (rats and mice) after oral administration or 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.

Antagonism occurs with β-lactam antibiotics, chloramphenicol and macrolides.

For 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.

When applied cutaneously, 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.

Pharmacotherapeutic group: Other antibiotics for topical use

ATCvet code: QD06AX

Clindamycin is a semi-synthetic antibiotic produced by 7(S)-chloro substitution of the 7(R)-hydroxy group of the natural antibiotic produced by Streptomyces lincolnensis var. lincolnensis.

Clindamycin, a mainly time-dependent acting antibiotic, acts by a bacteriostatic mechanism where the drug interferes with protein synthesis within the bacterial cell, thus inhibiting the growth and multiplication of the bacteria.

Clindamycin binds to the 23S ribosomal RNA component of the 50S subunit. This prevents amino acids binding on these ribosomes, and therefore inhibits peptide bond formation. The ribosomal sites are close to those bound by macrolides, streptogramins or chloramphenicol.

The spectrum of activity of lincosamides is similar to the macrolide antibiotics and includes streptococcus spp., staphylococcus spp. (including ß-lactamase-forming Staphylococcus aureus).

CLSI clindamycin veterinary breakpoints are available for dogs in Staphylococcus spp. and Streptococci-β-haemolytic group in skin and soft tissue infections: S≤0.5μg/ml; I=1-2µg/ml; R≥4μg/ml (CLSI February 2018). These breakpoints are established for systemic treatment and should be considered as indicative for topical treatment only.

Clindamycin belongs to the lincosamide group of antibiotics. Resistance can develop to the lincosamides alone, but more commonly cross-resistance occurs among macrolides, lincosamides and streptogramin B antibiotics (MLSB group). Resistance is the result of methylation of adenine residues in the 23S RNA of the 50S ribosomal subunit, which prevents drug binding to the target site. Different bacterial species are able to synthesize an enzyme, encoded by a series of structurally related erythromycin ribosomal methylase (erm) genes. In pathogenic bacteria, these determinants are mostly borne by plasmids and transposons that are self-transferable. The erm genes occur predominantly as variants erm(A) and erm(C) in Staphylococcus aureus and as variant erm(B) in Staphylococcus pseudintermedius, streptococci and enterococci.

MLSB inducible resistance is not detected by standard in vitro susceptibility testing methods. The CLSI recommends the D-zone test to be routinely performed in veterinary diagnostic laboratories in order to detect clinical isolates with inducible resistance phenotype. Clindamycin use should be discouraged in these patients. The incidence of resistance to lincosamides in Staphylococcus spp. appears to be wide-ranging in Europe. Studies (2010) report an incidence between 25-40%.

No data is available for clindamycin plasma levels or clindamycin levels in the inflamed area after application of the formulation.

All other information indicates that clindamycin is hardly absorbed through the skin.

In case clindamycin will be absorbed through the skin, distribution will be high due to the basic nature of the substance, and accumulation will occur in tissues with a lower pH than plasma.

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

Shelf life after first opening the immediate packaging: 28 days

Do not store above 25°C. Do not freeze.

Aluminium tube of 20 g in a cardboard box. The tube is sealed with a tamper evident aluminium membrane and closed with a white high-density polyethylene screw cap.

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

Dechra Regulatory BV, Handelsweg 25, 5531 AE Bladel, The Netherlands.

Vm 50406/4011

3 March 2021

March 2021

For animal treatment only. To be supplied only on veterinary prescription. Keep out of the sight and reach of children.