NV L-CARNITINE INJECTION
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
19-06-2023
Summary of Product characteristics
(SPC)
01-07-2013
Active ingredient:
CARNITINE - L
Available from:
CEVA ANIMAL HEALTH PTY LTD
INN (International Name):
carnitine(200mg/mL)
Pharmaceutical form:
MISC. VACCINES OR ANTI SERA
Composition:
CARNITINE - L VITAMIN-BT Active 200.0 mg/ml
Units in package:
100mL
Class:
VM - Veterinary Medicine
Manufactured by:
CEVA ANIMAL HEALTH
Therapeutic group:
DOG | HORSE | BITCH | CASTRATE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT
Therapeutic area:
NUTRITION & METABOLISM
Therapeutic indications:
MINERAL AND NUTRITIONAL ADDITIVE | ACETONAEMIA | ACTINOBACILLOSIS | AMINO ACID SUPPLEMENT | AMINO ACIDS | BONE FRAGILITY | BONE GROWTH | CALCIUM SUPPLEMENT | CARTILAGE STRENGTH | COPPER DEFICIENCY | EGG SHELL | FATTY ACID DEFICIENCY | FATTY LIVER | GLUCOSE | GRASS TETANY | HEPATOTOXIC DRUGS | HYPOCALCAEMIA | HYPOMAGNESAEMIA | ILEITIS | IODINE DEFICIENCIES | LACTATING | LAXATIVE | L-CARNITINE SUPPLEMENT | LIVER ABSCESS | LIVER DAMAGE | LYSINE DEFICIENCIES | MILK FEVER | MINERAL ADDITIVE | MYOPATHIES | MYOSITIS SYNDROME | PANGAMIC ACID | PHOSPHOROUS SUPPLEMENT | RICKETS | SELENIUM DEFICIENCY | SHELL STRENGTH | SOFT BONE DISEASE | VITAMIN B12 | VITAMIN D SUPPLEMENT | VITAMIN E DEFICIENCIES | ZINC DEFICIENCIES
Product summary:
Poison schedule: 0; Withholding period: WHP:Nil; Host/pest details: DOG: [MINERAL AND NUTRITIONAL ADDITIVE]; HORSE: [MINERAL AND NUTRITIONAL ADDITIVE]; Poison schedule: 0; Withholding period: ; Host/pest details: DOG: [MINERAL AND NUTRITIONAL ADDITIVE]; HORSE: [MINERAL AND NUTRITIONAL ADDITIVE]; Carnitine supplement for horses and dogs.
Authorization status:
Registered
Authorization date:
2023-07-01
Patient Information leaflet
Product Name:
APVMA Approval No:
NV L-CARNITINE INJECTION
40293/140132
Label Name:
NV L-CARNITINE INJECTION
Signal Headings:
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
200 mg/mL Carnitine
Claims:
Carnitine supplement for horses and dogs.
Net Contents:
100 mL
Directions for Use:
Restraints:
Contraindications:
Precautions:
Side Effects:
Dosage and
Administration:
Administer by intramuscular injection.
Horses: 3 mL/100 kg bodyweight
Dogs: 1 mL/10 kg bodyweight
Administer twice weekly or as directed by a veterinary surgeon.
After withdrawal of the first dose, use remaining product within 3
months after opening.
General Directions: RLP APPROVED
Withholding Periods:
NIL
Trade Advice:
Safety Directions:
First Aid Instructions:
If poisoning occurs, contact a doctor or Poisons Information Centre.
Phone Australia
131126.
First Aid Warnings:
Additional User
Safety:
Environmental
Statements:
Disposal:
Dispose of container by wrapping with paper and putting in garbage.
Discarded needles/
sharps should immediately be placed in a designated and appropriately
labelled ‘sharps’
container.
Storage:
Store below 25°C (Air Conditioning). Protect from light.
Keep out of reach of children.
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Summary of Product characteristics
L-Carnitine Injection
Creation Date: March 2004
Version: 3
Revision Date: May 2011
Next revision due: May 2016
MATERIAL SAFETY DATA SHEET
_L-CARNITINE INJECTION_
Page 1 of 6
COMPANY DETAILS
COMPANY:
ADDRESS:
Ceva Animal Health Pty Ltd
11 Moores Road
ABN 54 002 692 426
Glenorie NSW 2157 Australia
TELEPHONE NUMBER:
FACSIMILE NUMBER:
+61 (02) 9652 7000
+61 (02) 9652 7001
EMERGENCY TELEPHONE NUMBER:
+61 (02) 9652 7000 (Business Hours)
Poisons Information Centre: 131126
SUBSTANCE IDENTIFICATION
PRODUCT NAME: _NV L-Carnitine Injection _
_ _
OTHER NAMES: L-Carnitine
MANUFACTURER’S PRODUCT CODE: LCT
UN NUMBER: None allocated
DANGEROUS GOODS CLASS AND SUBSIDIARY RISK: None allocated
HAZCHEM CODE: None allocated
SUSDP POISONS SCHEDULE NUMBER: Not Scheduled
USE: Injectable L-carnitine supplement for use in horses and
dogs with confirmed deficiencies. For
animal treatment only.
STATEMENT OF HAZARDOUS NATURE: Not hazardous according to criteria
of NOHSC Australia.
RISK PHRASES: Not hazardous – no risk phrases identified.
SAFETY PHRASES: Not hazardous – no
safety phrases identified.
SECTION 1 – IDENTIFICATION OF MATERIAL AND SUPPLIER
SECTION 2 – HAZARDS IDENTIFICATION
L-Carnitine Injection
Creation Date: March 2004
Version: 3
Revision Date: May 2011
Next revision due: May 2016
MATERIAL SAFETY DATA SHEET
_L-CARNITINE INJECTION_
Page 2 of 6
The substance is a complex mixture, including the following
ingredients.
INGREDIENTS:
CHEMICAL NAME
CAS NUMBER
PROPORTION
*
L-Carnitine
541-15-1
20% (200 mg/mL)
Benzyl A
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