Clinacin 75 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:

75 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:

1999-01-22

Summary of Product characteristics

Health Products Regulatory Authority
22 November 2018
CRN008NGM
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Clinacin 75 mg Tablets for Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Clindamycin 75 mg (as clindamycin hydrochloride)
EXCIPIENT:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
A round white tablet, with a break-line on one side.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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 Osteomyelitis_
_·Staphylococcus aureus_
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to clindamycin or
lincomycin.
Do not administer to rabbits, hamsters, guinea pigs, chinchillas,
horses or ruminants
because ingestion of clindamycin by these species may result in severe
gastro-intestinal disturbance.
Health Products Regulatory Authority
22 November 2018
CRN008NGM
Page 2 of 5
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
During prolonged therapy of one month or greater, periodic liver and
kidney
function tests and blood counts should be performed. Patients 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.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
Wash hands after the administration of the product. Persons with known
hypersensitivity to lincosamides (lincomycin, clindamycin) should not
handle the
product.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Vomiting and diarrhoea are observed occasio