Zodon 150 mg chewable tablets for 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:

150 mg/tablet

Pharmaceutical form:

Chewable tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

clindamycin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2016-04-22

Summary of Product characteristics

Health Products Regulatory Authority
06 May 2021
CRN009XNY
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Zodon 150 mg chewable tablets for dogs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Clindamycin (as hydrochloride)
150 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet
Clover-shaped scored beige tablet. The tablet can be divided into four
equal parts.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
- For the treatment of infected wounds and abscesses, and oral cavity
infections including periodontal disease, caused by or
associated with _Staphylococcus _spp_., Streptococcus _spp_. (_except
_Streptococcus faecalis), Bacteroides _spp_., Fusobacterium _
_necrophorum, _and _Clostridium perfringens. _
- For the treatment of superficial pyoderma associated with
_Staphylococcus pseudintermedius_.
- For the treatment of osteomyelitis, caused by _Staphylococcus
aureus. _
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients or to lincomycin.
Do not administer to rabbits, hamsters, guinea pigs, chinchillas,
horses or ruminants because ingestionof clindamycin by these
species may result in severe gastro-intestinal disturbance.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The chewable tablets are flavoured. In order to avoid any accidental
ingestion, store tablets out of reach of the animals.
Use of the product should be based on susceptibility testing of the
bacteria isolated from the animal.
Official and local antimicrobial policies should be taken into account
when the product is used.
Use of the 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
lincomycin or macrolide antimicrobials d