Clindacyl 75 mg Tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clindamycin hydrochloride

Available from:

Vetoquinol Ireland 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:

2000-09-01

Summary of Product characteristics

Health Products Regulatory Authority
28 August 2019
CRN00987J
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Clindacyl 75 mg Tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE
Clindamycin 75 mg
(as Clindamycin Hydrochloride)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
A round white tablet with a breakline on one side.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Clindacyl 75 mg Tablets are antibiotics indicated for the treatment of
infected wounds, abscesses, pyoderma and oral
cavity/dental infections caused by or associated with
clindamycin-sensitive staphylococci, streptococci, pneumococci,
bacteroidaceae, _Fusobacterium necrophorum, Clostridium perfringens
_and osteomyelitis caused by _Staphylococcus aureus_.
Clindacyl 75 mg Tablets can also be used to help provide antimicrobial
cover during dental procedures.
4.3 CONTRAINDICATIONS
Do not administer to animals with hypersensitivity to clindamycin and
lincomycin preparations.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE
During prolonged osteomyelitis therapy of one month or greater,
periodic liver and kidney function tests and blood counts
should be performed. Patients with severe renal and/or very severe
hepatic disturbances accompanied by severe metabolic
aberrations should be dosed with caution and should be monitored by
serum examination during high dose clindamycin
therapy.
Treatment with clindamycin should be 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. Persons with known
hypersensitivity to lincosamides (lincomycin,
clindamycin) should not handle the product.
Health Products Regulatory Authority
28 August 2019
CRN00987J
Page 2 of 4
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNE