Clinacin 300 mg Tablets for Dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clindamycin hydrochloride

Available from:

Chanelle Pharmaceuticals Manufacturing Limited

ATC code:

QJ01FF01

INN (International Name):

Clindamycin hydrochloride

Dosage:

300 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

clindamycin

Authorization status:

Authorised

Authorization date:

2007-06-01

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Clinacin 300 mg Tablets for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
300 mg of clindamycin as clindamycin hydrochloride.
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Ludipress (Lactose monohydrate, Povidone and
Crospovidone)
Microcrystalline cellulose
Sodium laurilsulfate
Colloidal anhydrous silica
Magnesium stearate
Grilled meat flavour
A plain white to off white tablet with a cross break line on one side.
The tablets can be divided into halves or quarters.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the treatment of infected wounds, abscesses and oral cavity/dental
infections caused by or
associated with clindamycin-sensitive species of
_Staphylococcus, Streptococcus, Bacteroides, _
_Fusobacterium necrophorum _
and
_Clostridium perfringens _
and osteomyelitis caused by
_Staphylococcus aureus_
.
3.3
CONTRAINDICATIONS
Do not administer to rabbits, hamsters, guinea pigs, chinchillas,
horses, or ruminants because
ingestion of clindamycin by these species may result in severe
gastrointestinal disturbances.
Do not use in cases of known hypersensitivity to all lincosamides.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
During prolonged therapy of one month or greater, periodic liver and
kidney function tests and blood
counts should be performed. Canines with severe renal and/or hepatic
disturbances accompanied by
severe metabolic aberrations should be dosed with caution and should
be monitored by serum
examination during clindamycin therapy.
Whenever possible, the veterinary medicinal product should only be
used based on susceptibility
testing.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals:
Wash hands after the administration of the product.
People with known hypersensitivity to lincosamides (lincomycin,
clindamycin) sh