Zodon 25 mg/ml oral solution for cats and dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clindamycin

Available from:

Ceva Santé Animale

ATC code:

QJ01FF01

INN (International Name):

Clindamycin

Dosage:

25 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Dogs

Therapeutic area:

clindamycin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2016-04-22

Summary of Product characteristics

Health Products Regulatory Authority
21 March 2019
CRN000Z32
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Zodon 25 mg/ml oral solution for cats and dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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Each ml contains:
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ACTIVE SUBSTANCE:
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Clindamycin
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25
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mg
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(equivalent to 27.17 mg clindamycin hydrochloride)
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EXCIPIENTS:
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Ethanol 96% (E1510)
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72
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mg
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For the full list of excipients, see section 6.1.
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3 PHARMACEUTICAL FORM
Oral solution.
Clear, amber solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cats and dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cats:
For the treatment of infected wounds and abscesses caused by
clindamycin-susceptible species of _Staphylococcusspp_ and
_Streptococcus spp_.
Dogs:

​For the treatment of infected wounds, abscesses and oral
cavity/dental infections caused by or associated with
clindamycin-sensitive species of _Staphylococcus spp_, _Streptococcus
spp_, _Bacteroides spp_, _Fusobacterium _
_necrophorum_, _Clostridium perfringens_

Adjunctive treatment of mechanical or surgical periodontal therapy in
the treatment of infections of the gingival
and periodontal tissues

For the treatment of osteomyelitis caused by _Staphylococcus aureus_
4.3 CONTRAINDICATIONS
Do not use in hamsters, guinea pigs, rabbits, chinchillas, horses or
ruminants because clindamycin ingestion by these species
may cause severe gastrointestinal disorders.
Do not use in cases of hypersensitivity to either clindamycin or
lincomycin, or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
21 March 2019
CRN000Z32
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Inappropriate use of the product may increase the prevalence of
bacteria resistant to clindamycin. Whenever possible,
clindamycin should only be used based on susceptibility testing
includi