Clindaseptin 25 mg Capsules for Dogs

Land: Storbritannia

Språk: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv ingrediens:

Clindamycin

Tilgjengelig fra:

Chanelle Animal Health Ltd

ATC-kode:

QJ01FF01

INN (International Name):

Clindamycin

Legemiddelform:

Capsule, hard

Resept typen:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Dogs

Terapeutisk område:

Antimicrobial

Autorisasjon status:

Authorized

Autorisasjon dato:

2014-07-29

Preparatomtale

Revised: July 2019
AN: 01559/2018
Page 1 of 6
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT:
Clindaseptin 25 mg capsules for dogs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Active substance:
mg per capsule
Clindamycin.
25.0
(as clindamycin hydrochloride)
Excipients:
Capsule shell
Red Iron Oxide (E172)
0.57
Titanium Dioxide (E171)
0.19
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM:
Capsule, hard
Orange capsule
4.
CLINICAL PARTICULARS:
4.1
TARGET SPECIES:
Dogs.
4.2
INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES):
The
product
is
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_. The product can also be used to help provide antimicrobial
cover during
dental procedures.
4.3
CONTRA-INDICATIONS:
Do not use in cases of known hypersensitivity to clindamycin,
lincomycin
or to any
of the excipients.
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.
Revised: July 2019
AN: 01559/2018
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES:
Before the use of the product, the identification of causative
pathogenic micro-
organisms should be carried out and the sensitivity to clindamycin
should be
established.
4.5
SPECIAL PRECAUTIONS FOR USE
I) 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.
Use of the product is not recommended in sucklin