NIRAMINE 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

Safety Data Sheet (SDS)

08-11-1995

Active ingredient:

CHLORPHENIRAMINE MALEATE

Available from:

JUROX PTY LIMITED

INN (International Name):

chlorpheniramine as maleate(7mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

CHLORPHENIRAMINE MALEATE ANTIHISTAMINE Active 10.0 mg/ml

Units in package:

50mL

Class:

VM - Veterinary Medicine

Therapeutic group:

Therapeutic area:

ANTIHISTAMINES

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: Nil ESI: This product does no hav e an ESI established.; Host/pest details: CAT: [CORTICOSTEROID]; CATTLE: [CORTICOSTEROID]; DOG: [CORTICOSTEROID]; GOAT: [CORTICOSTEROID]; HORSE: [CORTICOSTEROID]; PIGS: [CORTICOSTEROID]; SHEEP: [CORTICOSTEROID]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [CORTICOSTEROID]; CATTLE: [CORTICOSTEROID]; DOG: [CORTICOSTEROID]; GOAT: [CORTICOSTEROID]; HORSE: [CORTICOSTEROID]; PIGS: [CORTICOSTEROID]; SHEEP: [CORTICOSTEROID]; For the treatment of allergic reactions in horses, cattle, sheep, goats, pigs, dogs and cats.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Niramine Injection (RLP)
31JUL12
(Copy in the header will not appear on the final printed label)
Vial label Panel 1/Catton Front and Back Panels
PRESCRIPTION
ANIMAL REMEDY
KEEP
OUT
OF
REACH
OF
CHILDREN
FOR
ANIMAL
TREATMENT
ONLY
NIRAMINE
INJECTION
10
mg/mL CHLORPHENIRAMINE
MALEATE
(equivalent to 7 mg/mL Chlorpheniramine)
1/2
•
RLP
Approved
For
the
treatment
of
allergic reactions in horses, cattle, sheep, goats, pigs, dogs
and
cats.
50ML
[JUROX LOGO]
Vial label Panel 2
DIRECTIONS
FOR
USE
DOSAGE AND ADMINISTRATION
IN USE
SHELF
LIFE:
After initial broaching, use all product within 28 days and store
betw
ee
n 2° and 8°C
(Ref
ri
gerate, Do
Not
Freeze, Store Upright).
Use subcutaneously or intramuscularly at the following dose rate
s:
Dogs, Cats, up tolO kg bodyweight: 0.5 mL.
Dogs over 10 kg: 0.5
mL
per 10 kg bodyweight.
Goats, Pigs, Sheep: 10 - 15 kg bodyweight: 1 - 2 mL,
15-
25
kg
bodyweight:
2-
3
mL
Cattle,
Hor
ses: 5
mL
per 500 kg bodyweight.
WITHHOLDING PERIOD: ZERO (0) DAYS.
TRADE ADVICE: ESI not established.
FIRST AID
If
poisoning occ
ur
s contact a doctor
or
Poisons Information
Ce
ntre.
Phone Austra
li
a 131126
DISPOSE
of
contain
er
by
wrapping with pa
per
a
nd
placing in garbage.
STORE bel
ow
30°C (Room Temperature). Protect from light. After initial broaching
use a
ll
product within 28 days and store between 2°C and 8°C (Refrigerate,
Do
Not
Fr
eeze, Store Upright).
Jurox
Pty
Limited
85
Gardiner Street, Rutherford
NSW
2320
Infoline 1800 023 312
B
EXP.
APVMA
36239/53467
[Item code]
Infopest
Verified
Niramine Injection (RLP)
31JUL12
2/2
(Copy in the header will not appear on the final printed label)
Carton Side Panel 1
DIRECTIONS FOR USE:
DOSAGE AND ADMINISTRATION
IN USE SHELF LIFE:
After initial broaching, use all product within 2g days and store
between 2e and
gee
(Refrigerate,
Do
Not
Freeze, Store Upright).
Use
subcutaneously or intramuscularly
at
the following dose rates:
Dogs, Cats, up tolO
kg
bodyweight: 0.5 mL.
Dogs
over
10 kg: 0.5
mL
per
10
kg
bodyweight.
Goats, Pigs, Sheep:
10
-
15
kg
bodyweight:

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Summary of Product characteristics

NIRAMINE INJECTION
Page 1 of 5
continued
ISSUED:
13 AUGUST 2012
SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME:
NIRAMINE INJECTION
PRODUCT CODE:
61060
RECOMMENDED USE:
For the treatment of allergic reactions in horses, cattle, sheep,
goats, pigs,
dogs and cats.
COMPANY IDENTIFICATION:
Jurox Pty Limited
ADDRESS:
85 Gardiner Street
Rutherford NSW 2320
Australia
CUSTOMER CENTRE:
1800 023 312
NATIONAL POISONS INFORMATION CENTRE:
131126 (Australia-wide)
EMERGENCY TELEPHONE NUMBER:
1800 023 312 (9a.m. – 5p.m.)
SECTION 2: HAZARDS IDENTIFICATION
GHS HAZARD CLASSIFICATIONS:
SKIN SENSITIZER CATEGORY 1
EXCLAMATION MARK
SIGNAL WORD:*
WARNING
HAZARD STATEMENTS:*
H317
May cause an allergic skin reaction.
PRECAUTIONARY STATEMENTS:*
PREVENTION
P261
Avoid breathing vapours/spray.
P272
Contaminated work clothing should not be allowed out of the workplace.
P280
Wear protective gloves e.g. PVC or vinyl and protective eyewear e.g.
Safety
glasses with eye side shields or chemical goggles.
RESPONSE
P302+P352
IF ON SKIN: Wash with plenty of soap and water.
P333+P313
If skin irritation or rash occurs: Get medical advice/attention.
P363
Wash contaminated clothing before reuse.
DISPOSAL
P501
Dispose of contents/container in accordance with local/national
regulations.
* N.B.: These statements are determined by Work Health and Safety
regulations and may not reflect Signal Headings and
First Aid and Safety statements on product labelling, which are
determined by a competent authority during assessment
for registration.
NIRAMINE INJECTION
Page 2 of 5
continued
SECTION 3: COMPOSITION / INFORMATION ON INGREDIENTS
INGREDIENT
CAS NO.
CONTENT
Chlorpheniramine maleate
113-92-8
1%
Water
7732-18-5
99%
SECTION 4: FIRST AID MEASURES
FIRST AID MEASURES:
Consult the National Poisons Centre on 131126 or a doctor immediately
in every case of
suspected chemical poisoning. Never give fluids or induce vomiting if
a patient is unconscious
or convulsing regardless of cause of injury. If medical
advice/attention is need

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Safety Data Sheet

WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Limited
TECHNICAL NOTES
ACTIVE CONSTITUENTS
Chlorpheniramine maleate 10 mg/mL (equivalent to 7 mg/mL
Chlorpheniramine).
ACTIONS
Chlorpheniramine is an antihistamine compound combining a high degree
of potency and rapidity of action with a relative absence
of undesirable side effects. Chlorpheniramine has 5 to 20 times the
activity on a weight basis of other commonly used antihistamines
such as mepyramine and promethazine. It also causes less sedation than
the former compound.
Chlorpheniramine may be useful in allergic conditions due to abnormal
histamine activation including dermatoses, insect bites and
stings, nonspecific pruritus, urticaria and skin irritation in serum
sickness and drug sensitivity; also supportive treatment in laminitis,
azoturia, mastitis, lantana poisoning and milk fever.
INDICATIONS
For the treatment of allergic reactions in horses, cattle, sheep,
goats, pigs, dogs and cats.
DOSAGE AND ADMINISTRATION
Use subcutaneously or intramuscularly at the following dose rates:
Dogs, Cats, up to 10 kg bodyweight:
0.5 mL
Dogs over 10 kg:
0.5 mL per 10 kg bodyweight
Cattle, Horses:
5 mL per 500 kg bodyweight
Goats, Pigs, Sheep (10-15 kg bodyweight):
1-2 mL
(15-25 kg bodyweight):
2-3 mL
NIRAMINE
Injection
WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Limited
TECHNICAL NOTES
WITHHOLDING PERIOD
ZERO (0) days.
TRADE ADVICE
This product does not have an ESI established.
For advice on the ESI contact Jurox Pty Limited on 1800 023 312 before
using this product.
FIRST AID
If poisoning occurs, contact a doctor or Poisons Information Centre on
13 1126
GHS INFORMATION
For GHS Information see Safety Data Sheet.
PRESENTATION
Injection (multi-dose vials): 50 mL.
STORAGE
STORE below 30°C (room temperature). After initial broaching use all
product within 28 days and store between 2°C and 8°C
(Refrigerate , Do Not Freeze, Store Upright).
POISONS SCHEDULE
S4.
REGISTRATION NUMBER
APVMA No. 36239
AU -

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