Clindacyl 300 mg Tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: VMD (Veterinary Medicines Directorate)

Wirkstoff:

Clindamycin

Verfügbar ab:

Vetoquinol UK Ltd

ATC-Code:

QJ01FF01

INN (Internationale Bezeichnung):

Clindamycin

Darreichungsform:

Tablet

Verschreibungstyp:

POM-V - Prescription Only Medicine – Veterinarian

Therapiegruppe:

Dogs

Therapiebereich:

Antimicrobial

Berechtigungsstatus:

Expired

Berechtigungsdatum:

2010-09-08

Fachinformation

Revised: June 2015
AN 01673/2014
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Clindacyl 300 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Clindamycin (as Clindamycin Hydrochloride) 300 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet
White round 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
300
mg
Tablets
are
indicated
for
the
treatment
of
infected
wounds,
abscesses, superficial pyoderma and oral cavity/dental infections
caused by or
associated with clindamycin-sensitive staphylococci, streptococci,
bacteroidaceae,
_Fusobacterium necrophorum_, _ Clostridium perfringens_ and
osteomyelitis caused by
_Staphylococcus aureus_. Clindacyl 300 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 or
any excipients or
to lincomycin preparations.
Do not administer to rabbits, guinea pigs, chinchillas, hamsters,
horses or ruminants.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Before the use of Clindacyl 300 mg tablets, the identification of
causative pathogenic
micro-organisms should be carried out and the sensitivity to
clindamycin should be
Revised: June 2015
AN 01673/2014
Page 2 of 6
established. Clindamycin and lincomycin show parallel resistance.
There is a partial
cross-resistance to erythromycin and other macrolide antibiotics.
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 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.
OFFICIAL AND