Clinacin 25 mg Tablets for Dogs

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Clindamycin hydrochloride

Dostopno od:

Chanelle Pharmaceuticals Manufacturing Limited

Koda artikla:

QJ01FF01

INN (mednarodno ime):

Clindamycin hydrochloride

Odmerek:

25 mg/tablet

Farmacevtska oblika:

Tablet

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtsko območje:

clindamycin

Status dovoljenje:

Authorised

Datum dovoljenje:

1999-10-29

Lastnosti izdelka

Health Products Regulatory Authority
22 November 2018
CRN008NGM
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Clinacin 25 mg Tablets for Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE: Clindamycin 25 mg (as clindamycin hydrochloride)
EXCIPIENT:
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
A small round white tablet, with a break-line on one side and the
letter J embossed
on both sides of the break-line.
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 (FREQUEN