CLINDENE 150 TABLETS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

CLINDAMYCIN AS CLINDAMYCIN HYDROCHLORIDE

Available from:

DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.

INN (International Name):

clindamycin as HCl(150mg/Tb)

Pharmaceutical form:

ORAL TABLET

Composition:

CLINDAMYCIN AS CLINDAMYCIN HYDROCHLORIDE ANTIBIOTIC Active 150.0 mg/Tb

Units in package:

100 tablet

Class:

VM - Veterinary Medicine

Manufactured by:

APEX LABORATORIES

Therapeutic area:

ANTIBIOTIC & RELATED

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [ACTINOMYCES SPP., BACTEROIDES SPP., CLOSTRIDIUM SPP., FUSOBACTERIUM SPP., PEPTOSTREPTOCOCCUS SPP., PROPIONIBACTERIUM SPP., STAPHYLOCOCCI, STAPHYLOCOCCUS AUREUS, STREPTOCOCCI]; For the treatment of dental infections, wounds, abscesses & osteomyelitis caused by bacteria susceptible to clindamycin in dogs & cats.DO NOT use in food producing species of animals or horses. DO NOT USE in guinea pigs, hamsters, rabbits or ruminants.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

CLINDENE 150 TABLETS
70247/140185
Product Name:
APVMA Approval
No:
Label Name:
CLINDENE 150 TABLETS
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Each tablet contains: 150mg CLINDAMYCIN (as clindamycin hydrochloride)
Claims:
For treatment of dental infections, wounds, abscesses and
osteomyelitis caused by
bacteria susceptible to clindamycin in dogs and cats. Resistance can
develop to any
antibiotic.
Net Contents:
100 tablets
Directions for Use:
Restraints:
DO NOT USE in food producing species of animals or horses.
DO NOT USE in guinea pigs, hamsters, rabbits or ruminants.
Contraindications:
This product is contraindicated in animals with a history of
hypersensitivity to Clindamycin
or Lincomycin.
Precautions:
Antagonism has been reported between Clindamycin and Erythromycin.
Periodic monitoring of hepatic and renal function as well as complete
blood counts should
be undertaken with prolonged (greater than one month) therapy.
Use with caution in patients with severe hepatic and or renal
disturbances accompanied by
metabolic aberrations. Such patients should have hepatic and renal
function monitored
during high dose therapy.
Clindamycin has been shown to have neuromuscular blocking properties.
Use with caution
in animals receiving neuromuscular blocking agents.
The safety of Clindamycin has not been established in breeding
animals.
Side Effects:
Clindamycin may cause overgrowth of non- susceptible organisms such as
resistant
Clostridium spp and yeasts. Vomiting and diarrhoea have occasionally
been observed. RLP APPROVED
Dosage and
Administration:
For oral administration only.
For the treatment of dental infections, wounds and abscesses
administer 5.5mg/kg
bodyweight twice daily or 11mg/kg bodyweight once daily for 7-10 days.
Treatment may be
extended up to 28 days. If no clinical improvement is observed within
4 days the sensitivity
of the pathogen should be redetermined.
For the treatment of osteomyelitis administer 11mg/kg bodyweight tw

Summary of Product characteristics

Safety Data Sheet
Product Name: Clindamycin Tablets
Issue Date: 02/2018
Version No: 1
Page 1 of 12
SECTION 1: IDENTIFICATION
1.1 PRODUCT IDENTIFIER
PRODUCT NAME:
Apex Clindamycin 150mg Tablets
SYNONYMS:
Not Available
PROPER SHIPPING NAME:
Not Available
OTHER MEANS OF
IDENTIFICATION:
None
1.2 RELEVANT IDENTIFIED USES OF THE SUBSTANCES OR MIXTURE AND USES
ADVISED AGAINST
RECOMMENDED USES:
For treatment of dental infections wounds, abscesses and
osteomyelitis caused by bacteria susceptible to Clindamycin in
dogs and cats.
USES ADVISED AGAINST:
None
1.3 DETAILS OF THE SUPPLIER OF THE SUBSTANCE OR MIXTURE
REGISTERED COMPANY
NAME:
Apex Laboratories Pty Ltd
ADDRESS:
Apex Laboratories Pty Ltd
ACN 614 716 700
2 Cal Close
Somersby NSW 2250
TELEPHONE:
1300 015 825 (Business hours: 08:30 – 17:30)
FAX:
[phone]
EMAIL:
[e-mail]
WEBSITE:
www.apexlabs.com.au
1.4 EMERGENCY TELEPHONE NUMBERS
13 11 26 (Poisons Information Centre)
SECTION 2: HAZARDS IDENTIFICATION
2.1 CLASSIFICATION OF THE SUBSTANCE OR MIXTURE
GHS CLASSIFICATION(S):
Serious eye damage/eye irritation – Category 2A
Sensitisation, skin – Category 1
2.2 LABEL ELEMENTS
SIGNAL WORD:
WARNING
HAZARD STATEMENT(S)
H319
Causes serious eye irritation
Safety Data Sheet
Product Name: Clindamycin Tablets
Issue Date: 02/2018
Version No: 1
Page 2 of 12
H317
May cause an allergic skin reaction
ADDITIONAL STATEMENT(S)
None
PRECAUTIONARY STATEMENT(S) PREVENTION:
P261
Avoid breathing dust
P264
Wash hands thoroughly after handling
P272
Contaminated work clothing should not be allowed out of the
workplace
P280
Wear protective gloves/protective clothing/eye protection/face
protection
PRECAUTIONARY STATEMENT(S) RESPONSE:
P305 + P351 + P338
If in eyes: rinse cautiously with water for several minutes.
Remove contact lenses, if present and easy to do. Continue
rinsing.
P337 + P313
If eye irritation persists: get medical advice/attention
P302 + P352
If on skin: wash with plenty of soap and water
P333 + P313
If skin irritation or rash occurs: get medical advice/attenti