Clinacin 300 mg Tablets for Dogs

Země: Velká Británie

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktivní složka:

Clindamycin

Dostupné s:

Chanelle Animal Health Ltd

ATC kód:

QJ01FF01

INN (Mezinárodní Name):

Clindamycin

Léková forma:

Tablet

Druh předpisu:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutické skupiny:

Dogs

Terapeutické oblasti:

Antimicrobial

Stav Autorizace:

Authorized

Datum autorizace:

2010-02-10

Charakteristika produktu

Revised: September 2020
AN. 00334/2020
Page 1 of 5
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:
Clindamycin (as Clindamycin Hydrochloride)
300 mg
EXCIPIENTS:
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
A plain white to off white tablet with a cross breakline on one side.
The tablets can be divided into halves or quarters.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Clinacin
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_. Clinacin 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 and
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 Clinacin 300 mg tablets, the identification of
causative pathogenic
micro-organisms should be carried out and the sensitivity to
clindamycin should be
established. Clindamycin and lincomycin show parallel resistance.
There is a partial
cross-resistance to erythromycin and other macrolide antibiotics.
Revised: September 2020
AN. 00334/2020
Page 2 of 5
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