Clinacin 150 mg Tablets for Dogs

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Clindamycin hydrochloride

Доступно од:

Chanelle Pharmaceuticals Manufacturing Limited

АТЦ код:

QJ01FF01

INN (Међународно име):

Clindamycin hydrochloride

Дозирање:

150 mg/tablet

Фармацеутски облик:

Tablet

Тип рецептора:

POM: Prescription Only Medicine as defined in relevant national legislation

Терапеутска област:

clindamycin

Статус ауторизације:

Authorised

Датум одобрења:

1999-11-26

Карактеристике производа

Health Products Regulatory Authority
22 November 2018
CRN008NGM
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Clinacin 150 mg Tablets for Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE: Clindamycin 150 mg (as clindamycin hydrochloride)
EXCIPIENT:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
An oblong white tablet, with a break-line on one side.
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-sensitive species of;
·_Staphylococcus_ spp.
·_Streptococcus_ spp.
·_Bacteroides _spp.
·_Fusobacterium necrophorum_
·_Clostridium perfringens_
_.Osteomyelitis _
·_Staphylococcus aureus_
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to clindamycin or
lincomycin.
Health Products Regulatory Authority
22 November 2018
CRN008NGM
Page 2 of 5
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. 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.
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.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Vomiting and diarrhoea are observed