CLINACIN VETERINARY TABLETS 75 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CLINDAMYCIN

Available from:

A.L. MEDI-MARKET LTD.

Pharmaceutical form:

TABLETS

Composition:

CLINDAMYCIN 75 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

CHANELLE PHARMACEUTICALS MANUFACTURING LTD., IRELAND

Therapeutic indications:

CLINACIN VETERINARY TABLETS is indicated for use in dogs for the treatment of infected wounds,abscesses, superficial pyoderma and oral cavity/dental infections caused by or associated withclindamycin-sensitive staphylococci, streptococci, bacteroidaceae, Fusobacterium necrophorum,Clostridium perfringens and osteomyelitis caused by Staphylococcus aureus. Clinacin veterinary can also be used to help provide antimicrobial cover during dental procedures.

Authorization date:

2022-05-31

Patient Information leaflet

VETERINARY MEDICINE PACKAGE LEAFLET
This medicine is supplied on veterinary prescription only
For use in animals only
1.
NAME, FORM, AND STRENGTH OF THE VETERINARY MEDICINE
CLINACIN VETERINARY TABLETS 300 MG
CLINACIN VETERINARY TABLETS
75 MG
2.
ACTIVE INGREDIENT
Each Clinacin veterinary tablet 300 mg contains:
300 mg of clindamycin (as clindamycin hydrochloride).
Each Clinacin veterinary tablet 75 mg contains:
75 mg of clindamycin (as clindamycin hydrochloride).
For a list of inactive ingredients and allergens see section 11:
'Additional information'.
3. WHAT IS THIS MEDICINE INTENDED FOR?
Antibiotic tablets for use in dogs to treat infected wounds,
abscesses, superficial pyoderma and oral
cavity/dental infections caused by or associated with
clindamycin-sensitive bacteria (staphylococci,
streptococci, bacteroidaceae, Fusobacterium necrophorum, Clostridium
perfringens) and to treat
osteomyelitis caused by Staphylococcus aureus. Clinacin can also be
used to help provide antimicrobial
cover during dental procedures.
THERAPEUTIC GROUP: Lincosamides.
4.
CONTRAINDICATIONS
Clinacin veterinary tablets are contra-indicated in animals that are
hypersensitive to clindamycin or
lincomycin preparations.
Do not administer to rabbits, guinea pigs, chinchillas, hamsters,
horses or ruminants.
Do not use clindamycin concomitantly with chloramphenicol or
macrolides as they may antogonise each
other at their target site.
5.
SIDE EFFECTS
Clindamycin sometimes causes the overgrowth of non-sensitive organisms
such as drug-resistant
clostridia and yeasts. In cases of superinfection, suitable measures
must be taken based on the clinical
condition. Vomiting and diarrhea have been observed occasionally.
If you notice any serious effects or other effects not mentioned in
this leaflet, please inform your
veterinary surgeon.
You can report side effects to the Ministry of Health (MoH) by
following the link ‘Reporting Side Effects
of Medication’ on the MoH home page (www.health.gov.il) which links
to an online form for reporting
side effec

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Clinacin Veterinary Tablets 75 mg
Clinacin Veterinary Tablets 300 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clinacin Veterinary Tablets 75 mg contain Clindamycin 75 mg (as
Clindamycin
Hydrochloride)
Clinacin Veterinary Tablets 300 mg contain Clindamycin 300 mg (as
Clindamycin
Hydrochloride)
EXCIPIENT(S): For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
Clinacin Veterinary Tablets 75 mg: Round, white tablet with a
breakline on one side.
Clinacin Veterinary Tablets 300 mg: A plain , white to off white
tablet with a cross
breakline on one side. The tablets can be divided into halves or
quarters.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Clinacin Veterinary 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 Veterinary 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 Veterinary 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
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.