DL-ACETYL METHIONINE INJECTABLE AMINO ACID SUPPLEMENT

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

01-07-2013

Summary of Product characteristics (SPC)

01-07-2013

Active ingredient:

N-ACETYL-DL-METHIONINE

Available from:

JAYDEE LABORATORIES PTY LTD

INN (International Name):

acetylmethionine(200mg/mL)

Pharmaceutical form:

INJECTION

Composition:

N-ACETYL-DL-METHIONINE AMINO ACID-METHIONINE Active 200.0 mg/ml

Units in package:

50mL

Class:

VM - Veterinary Medicine

Manufactured by:

JAYDEE LABORATORIES

Therapeutic group:

Therapeutic area:

NUTRITION & METABOLISM

Therapeutic indications:

Product summary:

Poison schedule: 0; Withholding period: WHP: NIL ESI: NOT REQUIRED; Host/pest details: CAT: [MINERAL AND NUTRITIONAL ADDITIVE]; CATTLE: [MINERAL AND NUTRITIONAL ADDITIVE]; DOG: [MINERAL AND NUTRITIONAL ADDITIVE]; GOAT: [MINERAL AND NUTRITIONAL ADDITIVE]; HORSE: [MINERAL AND NUTRITIONAL ADDITIVE]; PIGS: [MINERAL AND NUTRITIONAL ADDITIVE]; SHEEP: [MINERAL AND NUTRITIONAL ADDITIVE]; Poison schedule: 0; Withholding period: ; Host/pest details: CAT: [MINERAL AND NUTRITIONAL ADDITIVE]; CATTLE: [MINERAL AND NUTRITIONAL ADDITIVE]; DOG: [MINERAL AND NUTRITIONAL ADDITIVE]; GOAT: [MINERAL AND NUTRITIONAL ADDITIVE]; HORSE: [MINERAL AND NUTRITIONAL ADDITIVE]; PIGS: [MINERAL AND NUTRITIONAL ADDITIVE]; SHEEP: [MINERAL AND NUTRITIONAL ADDITIVE]; For use as a supportive therapy in the treatment of liver disease in horses, cattle, sheep, goats, pigs dogs and cats..

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

PANTONE 032 C

PANTONE 1385 C

DYELINE
File Name: 36730_XXXXX_50mL_Carton Label_MPL_V01.pdf
DATE CREATED: 20/10/2008 – REVISED 20/10/2008
SIZE: 45mm wide x 80mm high x 45mm deep
SCALE: 100% (A4 paper)
FOR ANIMAL TREATMENT ONLY
DL-ACETYL
METHIONINE
INJECTABLE AMINO
ACID SUPPLEMENT
Acetyl dl-Methionine 200 mg/mL
FOR USE AS A SUPPORTIVE THERAPY
IN THE TREATMENT OF LIVER DISEASE
IN HORSES, CATTLE, SHEEP, GOATS,
PIGS, DOGS AND CATS.
50 ML
VETOQUINOL S.A.

DISTRIBUTED BY
Distributed by:
AUSRICHTER PTY LTD
ABN 79 000 908 529
2/21 Chester Street, Camperdown NSW 2050
Phone: (02) 9517 1166
Manufactured by:
VETOQUINOL S.A.
Magny-Vernois BP 189
70204 LURE Cedex (France)
APVMA Approval No.: 36730/50ML/0108
STORE BELOW 25
O
C (AIR CONDITIONING).
PROTECT FROM LIGHT.
KEEP OUT OF REACH OF CHILDREN
Dispose of empty container by wrapping
in paper and putting in garbage. Discarded
needles/sharps should immediately be placed
in a designated and appropriately labelled
‘sharps’ container.
B:
Exp:
DIRECTIONS FOR USE: Administer by
slow intra-muscular injection.
DOSAGE: Horses, Cattle, Sheep,
Goats and Pigs: 10 mL per 100 kg
bodyweight. Dogs: 10 mL per 20
kg bodyweight. Cats: 1 mL per kg
bodyweight.
Repeat treatment after one week or as
directed by a veterinary surgeon.
WITHHOLDING PERIODS: NIL
EXPORT SLAUGHTER INTERVAL (ESI):
NOT REQUIRED.
FIRST AID: If poisoning occurs, contact
a doctor or Poisons Information
Centre. Phone Australia 131126.
DL-
ACE
TYL

MET
HIO
NIN
E
DL-ACETYL
METHIONINE



APPROVED
LABEL



Info

PEST

Verified

B:
Exp:
PANTONE 032 C

PANTONE 1385 C

DYELINE
File Name: 36730_XXXXX_50mL_Bottle Label_MPL_V01.pdf
DATE CREATED: 20/10/2008 – REVISED 20/10/2008
SIZE: 125mm wide x 40mm high
SCALE: 100% (A4 paper)
FOR ANIMAL TREATMENT ONLY
DL-ACETYL
METHIONINE
INJECTABLE AMINO
ACID SUPPLEMENT
Acetyl dl-Methionine 200 mg/mL
FOR USE AS A SUPPORTIVE THERAPY

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Summary of Product characteristics

Dl-Acetyl Methionine - Issue 1
I:\Msdsjuly2000\Intervet\Dl-Acetyl Methionine.Doc
Page 1 of 5
MATERIAL SAFETY DATA SHEET
DL-ACETYL METHIONINE




Date of Issue:
September 23, 1999
Company Address:
Intervet (Australia) Pty Limited
P.O. Box 6446,
Baulkham Hills B.C. NSW 2153
Phone: (02) 9680-6999
Fax:
(02) 9680-6980
Emergency Tel. No.
Veterinary Advisor
24 Hr Emergency Service:
(02) 9798-8441
1. IDENTIFICATION
1.10
Product Name:
Dl-Acetyl Methionine Injectable Amino Acid
1.11
Correct Shipping Name:
Not Available
1.12
Other Names:
Acetyl methionine
1.13
UNNO:
None Allocated
1.14
Hazchem Code:
None Allocated (not listed as a hazardous substance)
1.15
Dangerous Goods Class:
None
Sub-risk:
None Allocated (not listed as a hazardous substance)
1.16
Poison Schedule:
1.17
Manufacturers Product
Code:
1.18
Use:
Non-Prescription drug for animal treatment only – For
supportive therapy in liver disease as an injection for use in
horses, cattle, sheep, pigs, dogs and cats.
Dl-Acetyl Methionine - Issue 1
I:\Msdsjuly2000\Intervet\Dl-Acetyl Methionine.Doc
Page 2 of 5
1.2 Ingredients
1.20
Chemical Entity
CAS No.
Proportion per 100 mL
* Methionine DL acetyl
59-51-8
20.0 g
Potassium monophosphate
NL
+
Chlorocresol
59-50-7
+
Sodium phosphate
7558-79-4
+
Sodium hydroxide
1310-73-2
+
Water for injection
7732-18-5
To
100 mL
* Active Constituent
+ Confidential Manufacturing Information
1.21
Chemical Characterisation:
The amino acid methionine in a sterile injection.
1.3 Physical Description / Properties
1.30
Form:
Sterile liquid contained in 50 mL brown glass multidose
vials.
1.31
Colour:
Clear solution
1.32
Odour:
Slightly alcoholic odour
1.33
Change in Physical State:
Not relevant
1.34
SG
:
Not available
1.35
Vapour Pressure:
Not available
1.36
Viscosity:
Not relevant
1.37
Solubility in Water:
Miscible
1.38
pH Value:
Not available
1.39
Flash Point:
Non flammable
1.40
Ignition Temperature:
Not relevant
1.41
Exp

Read the complete document