DEPOCILLIN PROCAINE PENICILLIN 300MG/ML INJECTION

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:

PROCAINE PENICILLIN

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

procaine penicillin(300mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

PROCAINE PENICILLIN ANTIBIOTIC-PENICILLIN Active 300.0 mg/ml

Units in package:

100mL; 250mL

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: Meat: Do not use less than 5 days before slaughter for human consumption. Milk: Milk collected from animals with in 36 hours (single dose) or 72 hours (multiple dose) following treatment must not be used for human consumption. Th is milk should not be fed to bobby calv es. ESI: This product does not have an ESI established.; Host/pest details: CAT: [ANTIBIOTICS - ORAL, PARENTERAL]; CATTLE: [ANTIBIOTICS - ORAL, PARENTERAL]; DOG: [ANTIBIOTICS - ORAL, PARENTERAL]; HORSE: [ANTIBIOTICS - ORAL, PARENTERAL]; PIGS: [ANTIBIOTICS - ORAL, PARENTERAL]; SHEEP: [ANTIBIOTICS - ORAL, PARENTERAL]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [ANTIBIOTICS - ORAL, PARENTERAL]; CATTLE: [ANTIBIOTICS - ORAL, PARENTERAL]; DOG: [ANTIBIOTICS - ORAL, PARENTERAL]; HORSE: [ANTIBIOTICS - ORAL, PARENTERAL]; PIGS: [ANTIBIOTICS - ORAL, PARENTERAL]; SHEEP: [ANTIBIOTICS - ORAL, PARENTERAL]; An aid in the treatment of infections caused by penicillin-sensitive organisms in horses, cattle, sheep, pigs, dogs and cats.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS)
(VETERINARY PRODUCTS)
APVMANO:
37258
DATE: 16
1
H
AUGUST 2013
PRODUCT NAME:
DEPOCILLIN PROCAINE PENICILLIN 300 MG/ML INJECTION
Select appropriate:
IJ
New Product (include all applicable RLPs) OR
!IDVariation (highlight instructions that are being varied). Approval
no.
of
label being varied:
37258/1 OOM/0709, 37258/250M/0709
Label Components include
in
product label: Vial and Carton
Signal
heading:
PRODUCT
NAME:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
DEPOCILLIN® PROCAINE PENCILLIN 300 MG/ML INJECTION
Active
constituent/s:
VIAL:
PROCAINE PENICILLIN 300 mg/mL
Statement
of
claims:
CARTON FRONT/BACK PANEL, CARTON TOP FLAP, LEAFLET:
ACTIVE CONSTITUENT:
PROCAINE PENICILLIN 300 mg/mL
RTON
PANEL:
An
aid
in
the treatment
of
infections caused by penicillin-sensitive organisms
in
Horses, Cattle, Sheep, Pigs, Dogs and Cats.
LEAFLET:
INDICATIONS:
An
aid
in
the treatment of infections caused by penicillin-sensitive organisms
in
Horses, Cattle, Sheep, Pigs, Dogs and Cats.
Vial,
Carton
front/back
panel,
Carton top flap, Leaflet
Vial,
Carton
front/back
panel,
Carton top flap, Leaflet
Vial,
Carton
front/back
panel,
Carton top flap, Leaflet
Vial,
Carton
front/Back
Panel,
Leaflet
+
RLP
Approved
Net
contents:
Directions
for
Use
HEADING:
RESTRAINTS:
CONTRAINDICATIONS:
PRECAUTIONS:
Side
effects:
Dosage
&
ADMINISTRATION:
VIAL: 100 mL and 250 mL
Vial: READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE:
Carton Side Panel1: READ THE ENCLOSED LEAFLET BEFORE USING THIS
PRODUCT.
DIRECTIONS FOR USE:
Leaflet:
DIRECTIONS FOR USE:
Not required.
CONTRAINDICATIONS:
This product is contraindicated for use
in
animals that are
known to be allergic to
penicillin.
DEPOCILLIN® not to
be
used when
it
is
known
that
1?.-lactamase
producing bacteria are involved.
PRECAUTIONS:
Persons who are allergic to penicillins should avoid direct contact
with the product.
This product contains Povidone (PVP) which may cause anaphylaxis
in
young
cattle-
antihi

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Summary of Product characteristics

PRODUCT NAME: DEPOCILLIN PROCAINE PENICILLIN 300MG/ML
INJECTION
MATERIAL SAFETY DATA SHEET
THIS REVISION ISSUED: JULY, 2009
PAGE: 1 OF 6
MATERIAL SAFETY DATA SHEET
Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461
(Business Hours)
Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800
764 766 in New Zealand)
SUBSTANCE:
Water solution of procaine penicillin and other ingredients in 100mL
and 50 mL multidose
vials
TRADE NAME:
DEPOCILLIN PROCAINE PENICILLIN 300MG/ML INJECTION
RECOMMENDED USE:
Prescription Only drug for animal treatment only - An antibiotic
injection for use in horses,
cattle, sheep, pigs, dogs and cats.
APVMA NO:
37258
CREATION DATE:
October, 2006
THIS VERSION ISSUED:
July, 2009
and is valid for 5 years from this date.
STATEMENT OF HAZARDOUS NATURE:
THIS PRODUCT IS CLASSIFIED AS:
Not classified as hazardous according to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S25, S45. Avoid contact with eyes. In case of accident or if you feel
unwell, contact a doctor or
Poisons Information Centre immediately (show the label where
possible).
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
PHYSICAL DESCRIPTION & COLOUR:
White to off-white liquid.
ODOUR:
Characteristic odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product. A
significant ingredient is an
antibiotic. Any person with a history of allergies to this class of
substances should avoid all contact with this product as it
may cause sensitisation.
This is an antibiotic preparation, and has mild acute effects.
However, if taken in large quantities, or under non medical
supervision, may cause adverse health effects. Unlikely to cause
problems in normal use.
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. However
product may be mildly
irritating, although un

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