Clinacin 75 mg Tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: VMD (Veterinary Medicines Directorate)

קנה את זה

מאפייני מוצר מאפייני מוצר (SPC)
04-01-2023

מרכיב פעיל:

Clindamycin

זמין מ:

Chanelle Animal Health Ltd

קוד ATC:

QJ01FF01

INN (שם בינלאומי):

Clindamycin

טופס פרצבטיות:

Tablet

סוג מרשם:

POM-V - Prescription Only Medicine – Veterinarian

קבוצה תרפויטית:

Dogs

איזור תרפויטי:

Antimicrobial

מצב אישור:

Authorized

תאריך אישור:

2001-01-26

מאפייני מוצר

                                Revised: March 2019
AN: 01178/2018
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Clinacin 75 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE: Clindamycin 75 mg (as Clindamycin Hydrochloride)
EXCIPIENT(S): For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
Round, white tablet with a breakline on one side
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE,SPECIFYING THE TARGET SPECIES
Clinacin
75
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 75 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 75 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.
4.5
SPECIAL PRECAUTIONS FOR USE
Revised: March 2019
AN: 01178/2018
Page 2 of 4
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 by serum examination
during high
dose clindamycin therapy.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERIN
                                
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