Clindaseptin 25 mg capsules for dogs

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Clindamycin hydrochloride

Предлага се от:

Chanelle Pharmaceuticals Manufacturing Limited

АТС код:

QJ01FF01

INN (Международно Name):

Clindamycin hydrochloride

дозиране:

25 Milligrams per capsule

Лекарствена форма:

Capsule

Вид предписание :

POM: Prescription Only Medicine as defined in relevant national legislation

Терапевтична област:

clindamycin

Статус Оторизация:

Authorised

Дата Оторизация:

2014-07-18

Данни за продукта

Health Products Regulatory Authority
12 September 2019
CRN008W1S
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Clindaseptin 25 mg capsules for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH CAPSULE CONTAINS:
ACTIVE SUBSTANCE:
Clindamycin (as Clindamycin Hydrochloride) 25 mg.
EXCIPIENTS:
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Capsule
The capsule has an orange body and an orange cap.
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 clindamycin lincomycin or
pirlimycin and/or 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.
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 the 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 potential for cross resistance.
Whenever possible, clindamycin should only be used based on
susceptibility test