VOREN

Main information

  • Trade name:
  • VOREN DEXAMETHASONE ESTER FOR INJECTION
  • Pharmaceutical form:
  • PARENTERAL LIQUID/SOLUTION/SUSPENSION
  • Units in package:
  • 50mL
  • Class:
  • Veterinary Medicine
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VOREN DEXAMETHASONE ESTER FOR INJECTION
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • CAT | CATTLE | DOG | HORSE | PIGS | SHEEP EWE (FEMALE) | BEEF | BITCH | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BUL
  • Therapeutic area:
  • corticosteroid
  • 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:
  • 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.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 35959/102379
  • Authorization date:
  • 19-01-2016
  • Last update:
  • 15-06-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

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 lead to a normal restoration of adrenal function.

As glucocorticoids inhibit antigen-antibody reaction but not antibody formation, the

treatment of acute or latent infectious conditions should only be undertaken with

appropriate antibiotic cover.

Dosage and

Administration:

As Voren is a microcrystalline suspension, and is well tolerated locally; parenteral routes of

administration may be employed at the following dosages:

Horses:

1mL per 50kg bodyweight by intramuscular injection

Cats/Dogs:

0.1 mL per kg bodyweight by intramuscular or subcutaneous injection

Doses into the synovial cavities should be reduced depending on the size of the joint cavity

involved. Should a second injection be necessary, this may be given on about the fifth day

after the first treatment, as Voren has a length of action of four days.

General Directions:

Composition

Voren® suspension is an aqueous, microcrystalline suspension of pyridine-4-carbonic acid

(dexamethasone 21) - ester having 1 mg of active substance per mL. 0.2% Nipagin/Nipasol

is added as a preservative.

Pharmacology

Glucocorticoid effect: The glucocorticoid activity of Voren was tested, after various modes

of administration, by the liver glycogen test, carried out on male rats which had been

starved for 24 hours. The parent substance, dexamethasone, served as a comparison.

After a single intramuscular injection of equimolar doses of Voren and dexamethasone, the

degree of increase of liver glycogen was evaluated with regard to the duration of action. It

was shown that the action of Voren (4 days) was maintained for a longer time than that of

dexamethasone (3 days). The index of activity of Voren is about 3 times higher than that of

dexamethasone.

Inflammation-inhibiting properties

The standard test of anti-proliferative action (the cotton pellet test in the rat) indicated that

equimolar doses produced a ratio of activity of Voren to dexamethasone of almost 28:1 in

topical use and 6:1 by intramuscular use. Oral medication indicated an equipotent activity.

A modified granuloma pouch technique was used to test the anti-exudative action of Voren

compared with dexamethasone 24 hours after the application of equimolar doses by more

than 6 times. 48 hours after application, the action of Voren was even more marked, while

that of dexamethasone had completely died away.

Action on electrolytes

The mineralocorticoid action of Voren was tested in comparison with dexamethasone by

the sodium-potassium excretion test, carried out in adrenalectomised rats. The sodium

showed no significant changes. The increase in potassium excretion was shown to be

dependent upon the dose and on the time interval between administration and testing.

lnitially Voren fell behind dexamethasone in its potassium-excreting potency. However,

after 48 hours Voren surpassed dexamethasone in this action, so that the total excretion for

the two substances over the 48-hour period is practically the same.

Clinical

The well-known and proven pharmacological advantages of Voren have been confirmed in

extensive clinical use.

In all the indications listed below, Voren proved itself too, and led to rapid recovery and

a significantly lowered proportion of relapses. This action can probably be attributed to

the marked depot-effect. ln all cases, the dose in mg was about 1/10 of the lowest usual

amount of prednisolone. Pharmacological examinations have shown that the peripheral

action on the metabolism is stronger than in any other glucocorticoids yet known, but

that the inhibitory effect on the hypophysis-adrenal cortex-system is less than that of

dexamethasone. For this reason undesirable side-effects need not be anticipated, e.g. the

polydipsia seen in dogs after prednisolone therapy does not occur.

Indications

Horses: Tenosynovitis, bursitis, arthritis, azoturia, etc.

Dogs/Cats: Eczema, otitis, arthritis, allergies, early intervertebral disc syndrome, etc.

For Official Use Only

In all species as an anti-inflammatory and anti-allergic agent, and for a general increase in

toxin tolerance, in infections such as:

Infections of young animals

Peritonitis

Withholding

Periods:

DO NOT USE in horses that may be used for human consumption.

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 empty container by wrapping with paper and putting in garbage.

Storage:

Store below 25°C (Air Conditioning). Do not freeze. Unused portion of the product should

be discarded after 28 days from the date of first use. After broaching, the product should be

stored in an upright position.

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