VOREN DEXAMETHASONE ESTER FOR INJECTION
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
19-06-2017
Send request.
Active ingredient:
DEXAMETHASONE 21-ISONICOTINATE
Available from:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
INN (International Name):
dexamethasone isonicotinate(1mg/mL)
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
DEXAMETHASONE 21-ISONICOTINATE STEROID-GLUCOCORTICOID Active 1.0 mg/ml
Units in package:
50mL
Class:
VM - Veterinary Medicine
Therapeutic group:
CAT | CATTLE | DOG | HORSE | PIGS | SHEEP EWE (FEMALE) | BEEF | BITCH | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BUL
Therapeutic area:
ENDOCRINE SYSTEM
Therapeutic indications:
ALLERGIES | ANTI-INFLAMMATORY AGENT | ARTHRITIS | AZOTURIA | BURSITIS | ECLAMPSIA | ECZEMA | GRASS TETANY | INTERVERTEBRAL DISC SYNDROME | KETOSIS | MASTITIS | OEDEMA | OTITIS EXTERNA | PERITONITIS | POST-PARTURIENT PARESIS | PREGNANCY TOXAEMIA | PREOPERATIVE SHOCK PROPHYLAXIS | PUERPERAL SEPSIS | SUNBURN | TENOSYNOVITIS | ACETONAEMIA | ACUTE CANINE OTITIS | ALLERGIC DISEASES | ANTIPYRETIC | ASSOCIATED WITH YEAST &/OR BAC | BONE SORENESS | BRUISING | BURSITIS | CHRONIC CANINE OTITIS | ELEVATED KETONES | EXERTIONAL RHABDOMYOLYSIS | HYPOMAGNESAEMIA | INFLAMMATORY RHEUMATIC ARTHRIT | JOINT DISEASE | LIGAMENT SPRAINS | MALASSEZIA PACHYDERMATIS | MUSCLE SORENESS | NON-CLINICAL KETOSIS | OSTEOARTHRITIS | OTITIS (CANINE) | PHYSIOLOGICAL OF THE MAMMARY G | PLATELET ACTIVITY | RHEUMATISM | SPRAINS | STAGGERS | STRAINS | SUBCLINICAL MASTITIS | TENDON SPRAINS | TRAUMATIC SWELLING | TYING-UP
Product summary:
Poison schedule: 4; Withholding period: WITHOLDING PERIOD: Do not use less tha n 28 days before slaughter for human co nsumption. TRADE ADVICE: EXPORT SLAUGH TER INTERVAL (ESI): This product does n ot have an ESI established. For advice on the ESI, contact the manufacturer on 1800 038 037 before using this product .; Host/pest details: CAT: [ALLERGIES, ANTI-INFLAMMATORY AGENT, ARTHRITIS, ECZEMA, INTERVERTEBRAL DISC SYNDROME, MASTITIS, OTITIS EXTERNA, PERITONITIS, PUERPERAL SEPSIS]; DOG: [ALLERGIES, ANTI-INFLAMMATORY AGENT, ARTHRITIS, ECZEMA, INTERVERTEBRAL DISC SYNDROME, MASTITIS, OTITIS EXTERNA, PERITONITIS, PUERPERAL SEPSIS]; HORSE: [ALLERGIES, ANTI-INFLAMMATORY AGENT, ARTHRITIS, AZOTURIA, BURSITIS, MASTITIS, PERITONITIS, PUERPERAL SEPSIS, TENOSYNOVITIS]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [ALLERGIES, ANTI-INFLAMMATORY AGENT, ARTHRITIS, ECZEMA, INTERVERTEBRAL DISC SYNDROME, MASTITIS, OTITIS EXTERNA, PERITONITIS, PUERPERAL SEPSIS]; DOG: [ALLERGIES, ANTI-INFLAMMATORY AGENT, ARTHRITIS, ECZEMA, INTERVERTEBRAL DISC SYNDROME, MASTITIS, OTITIS EXTERNA, PERITONITIS, PUERPERAL SEPSIS]; HORSE: [ALLERGIES, ANTI-INFLAMMATORY AGENT, ARTHRITIS, AZOTURIA, BURSITIS, MASTITIS, PERITONITIS, PUERPERAL SEPSIS, TENOSYNOVITIS]; For the treatment of diseases that respond to corticosteroid therapy in horses, dogs & cats..Contraindications: Osteoporotic processes, diabetes mellitus, and active tuberculosis; Voren should not be used during the last third of pregnancy.
Authorization status:
Stopped
Authorization date:
2021-07-01
Patient Information leaflet
BOEHRINGER INGELHEIM PTY LIMITED, VETMEDICA DIVISION
VOREN DEXAMETHASONE ESTER FOR INJECTION
35959/102379
COMPANY NAME:
PRODUCT NAME:
APVMA APPROVAL NO:
LABEL NAME:
VOREN DEXAMETHASONE ESTER FOR INJECTION
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
1 mg/ml DEXAMETHASONE ISONICOTINATE
CLAIMS:
For the treatment of diseases that respond to corticosteroid therapy
in horses, dogs and
cats.
NET CONTENTS:
50mL
DIRECTIONS FOR USE:
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
SHAKE well before use
USE within 4 weeks of initial broaching
RESTRAINTS:
DO NOT USE in horses that may be used for human consumption.
CONTRAINDICATIONS:
This product is contraindicated for use in animals suffering from
osteoporotic processes,
diabetes mellitus, and active tuberculosis.
This product is contraindicated for use in the last third of
pregnancy.
PRECAUTIONS:
SIDE EFFECTS:
In very rare cases anaphylactic reactions can occur. These reactions
can be fatal.
In spite of its prolonged and increased specific glucocorticoid
action, after parenteral
administration, as compared with other corticoids derivatives, Voren
does not show any
significant increase in toxicity. The acute toxicity (LD50) in mice
after intraperitoneal
administration, and an observation time of 7 days is 446 mg/kg.
In an evaluation of the sub-chronic toxicity of Voren (application
over a period of 16 weeks), RLP APPROVED
it was shown that besides its specific steroid effects, Voren produced
no other non-specific
organ damage. In the same manner as all other glucocorticoids, Voren
causes an inhibition
of ACTH production, which leads to a diminished activity of the
adrenal cortex for the
duration of the treatment. This state, however, is reversible, and
only calls for extra caution
in a prolonged treatment with repeated administration. In cases of
prolonged administration
the doses of Voren should be gradually withdrawn towards the end of
treatment. Gradual
withdrawal to the substance should l
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