Clindaseptin 150 mg capsules 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:

150 Milligrams per capsule

Pharmaceutical form:

Capsule

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

clindamycin

Authorization status:

Authorised

Authorization date:

2013-06-28

Summary of Product characteristics

Health Products Regulatory Authority
12 November 2018
CRN008QMW
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Clindaseptin 150 mg capsules for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
ACTIVE SUBSTANCE:
Clindamycin (as Clindamycin Hydrochloride) 150 mg
EXCIPIENTS:
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Capsule
The capsule has a lavender body and a maroon cap marked CL150.
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-susceptible species of
_Staphylococcus _spp.,
_Streptococcus_ spp., _Bacteroides _spp., _Clostridium perfringens
_and_ Fusobacterium _
_necrophorum._
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 or to pirlimycin. 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
12 November 2018
CRN008QMW
Page 2 of 7
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. Animals 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.
_ _
Inappropriate use of the product or deviating from the instructions
given in SPC may
increase the prevalence of bacteria resistant to clindamycin and may
decrease the
effectiveness of treatment with lincomycin or macrolide antimicrobials
due to the
potenti