ANTIROBE ANTIBIOTIC CAPSULES 25MG

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

19-06-2017

Summary of Product characteristics (SPC)

19-06-2017

Active ingredient:

CLINDAMYCIN AS CLINDAMYCIN HYDROCHLORIDE

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

clindamycin as HCl(25mg/Cp)

Pharmaceutical form:

ORAL CAPSULE

Composition:

CLINDAMYCIN AS CLINDAMYCIN HYDROCHLORIDE ANTIBIOTIC Active 25.0 mg/Cp

Units in package:

150 Caps; 80 Caps

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [ACTINOMYCES SPP., BACTEROIDES SPP., CLOSTRIDIUM SPP., FUSOBACTERIUM SPP., PEPTOSTREPTOCOCCUS SPP., PROPIONIBACTERIUM SPP., STAPHYLOCOCCI, STAPHYLOCOCCUS AUREUS, STREPTOCOCCI]; DOG: [ACTINOMYCES SPP., BACTEROIDES SPP., CLOSTRIDIUM SPP., FUSOBACTERIUM SPP., PEPTOSTREPTOCOCCUS SPP., PROPIONIBACTERIUM SPP., STAPHYLOCOCCI, STAPHYLOCOCCUS AUREUS, STREPTOCOCCI]; For oral administration to dogs and cats in the treatment of susceptible infections.Not to be used in food producing species of animals or horses. Not to be use in rabbits, hamsters or guinea pigs.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

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Use
of
llris
product
is
contraindJceted
in
an
i
mals
with
11tistory
ol
hypersensitivity
ID
cUndamycin
or
fincornycin.
Antagonism
has
been
demonsttlled
between
clindamycln
1nd
erylhromycin
.
During
prolonged
1hen1py
ol
one
month
or
greater,
periodic
liver
and
kidney
lunc1ion
tests
and
blood
counts
should
be
performed
.
Patients
with
severe
renal
and/or
very
severe
hepatic
disturbances
1ccornpanied
by
severe
metabolic
aberrations
should
be
dosed
with
caullon
and
should
be
monitored
by
serum
ex
amination
during
high-dose
cllndamycln
therapy
,
Use
with
ceution
in
enlmals
receiving
neuromuscular
blocking
agents
.
S
afety
In
gestating
bhches,
queens
or
br
eeding
ma
le
dogs
and
cats
has
not
been
established
.
CUndamycin
sometimes
ca
u
ses
the
overgrowth
ol
non·suaceptlbla
organisms
such
as
some
clostridia
and
yeests
.
Vo
m
iting
and
diarrhoea
have
ooceslonelly
been
observed
,
DIRECTIONS
FOR
USE
Restraints:
NOT
TO
BE
USED
in
food
producing
spec
i
es
of
enimels
or
horses
.
NOT
TO
BE
USED
in
rabbiiS
,
hamsters
or
guinea
pigs
.
Precautions
:
Refer
to
side
panel
before
use.
Dosage
and
Administnrtion

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Summary of Product characteristics

PRODUCT NAME: ANTIROBE ANTIBIOTIC CAPSULES
PAGE: 1 OF 7
THIS VERSION ISSUED: 5 FEBRUARY 2015
SAFETY DATA SHEET
Issued by: Zoetis Australia Pty Ltd
Phone: 1800 814 883
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 1 - IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND SUPPLIER
ZOETIS AUSTRALIA PTY LTD
ABN 94 156 476 425
Level 6, 5 Rider Blvd
Rhodes NSW 2138 AUSTRALIA
Tel: 1800 814 883
Fax: (02) 8876 0444
Email: australia.animalhealth@zoetis.com
PRODUCT IDENTIFIER:
ANTIROBE ANTIBIOTIC CAPSULES
OTHER NAMES:
None.
CHEMICAL FAMILY:
Clindamycin is an antibiotic agent.
APVMA APPROVAL NUMBER:
38717 (150mg), 38178 (75mg), 38719 (25mg)
RECOMMENDED USE:
Veterinary product used as antibiotic agent.
RESTRICTIONS ON USE
For veterinary use only.
EMERGENCY PHONE:
1800 814 883 (ALL HOURS)
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Xi, Irritating. Hazardous according to the criteria of SWA.
Not a Dangerous Good according to Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
RISK PHRASES:
R36, R43. Irritating to eyes. May cause sensitisation by skin contact.
SAFETY PHRASES:
S23, S25, S28, S36. Do not breathe dusts. Avoid contact with eyes.
After contact with skin, wash
immediately with plenty of soap and water. Wear suitable protective
clothing.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
GHS LABEL ELEMENTS:
GHS SIGNAL WORD: WARNING
GHS CLASSIFICATION:
H317: May cause an allergic skin reaction.
H320: Causes eye irritation.
PREVENTION
P102: Keep out of reach of children.
P261: Avoid breathing dusts.
P262: Do not get in eyes, on skin, or on clothing.
P264: Wash contacted areas thoroughly after handling.
P272: Contaminated work clothing should not be allowed out of the
workplace.
P280: Wear protective gloves, protective clothing and eye or face
protection.
RESPONSE
P312: Call a POISON CENTRE or doctor if you feel unwell.
P362: Take off contaminated clothin

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