Pro-Dynam Oral Powder 1 g phenylbutazone per sachet

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Phenylbutazone
Available from:
Dechra Veterinary Products A/S
ATC code:
QM01AA01
INN (International Name):
Phenylbutazone
Dosage:
1.0 g/sachet
Pharmaceutical form:
Oral powder
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Non food-producing horses
Therapeutic area:
phenylbutazone
Therapeutic indications:
N.S.A.I.D.
Authorization status:
Authorised
Authorization number:
VPA10803/001/001
Authorization date:
2000-10-01

Read the complete document

IRISH MEDICINES BOARD ACT 1995

EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (No. 2) REGULATIONS 2007

(S.I. No. 786 of 2007)

VPA:

10803/001/001

Case No: 7006940

The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby

grants to:

Dechra Veterinary Products A/S

Mekuvej 9

DK-7171 Uldum

Denmark

an authorisation, subject to the provisions of the said Regulations and the general conditions of the attached authorisation, in respect of the

Veterinary Medicinal Product:

Pro-Dynam Oral Powder, 1 g phenylbutazone per sachet

The particulars of which are set out in Part 1 and Part 2 of the said Schedule. The authorisation is also subject to any special conditions as may

be specified in the said Schedule.

The authorisation,unless revoked, shall continue in force from

12/11/2009

Signed on behalf of the Irish Medicines Board

________________

A person authorised in that behalf by the said Board.

(NOTE: This authorisation replaces any previous authorisation in respect of this product which is now null and void.)

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1

Part II

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Pro-Dynam Oral Powder 1 g phenylbutazone per sachet

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance

Each 5g sachet contains phenylbutazone 1 g

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

White oral powder.

4 CLINICAL PARTICULARS

4.1 Target Species

Horses

4.2 Indications for use, specifying the target species

The product is indicated for the treatment of musculoskeletal conditions in the horse where relief from pain and a

reduction in the associated inflammation is required, e.g. in lameness associated with osteoarthritic conditions, bursitis,

laminitis and soft tissue inflammation, particularly where continued mobility is considered desirable.

It is also of value in limiting post surgical inflammation, myositis and other soft tissue inflammation.

Pro-Dynam can be used as an anti-pyretic where this is considered advisable e.g. in viral respiratory infections.

4.3 Contraindications

Do not use in animals with known hypersensitivity to the active ingredient.

Use is contra-indicated in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of

gastro-intestinal ulceration or bleeding or where there is evidence of a blood dyscrasia.

Do not administer other NSAID’s concurrently or within 24 hours of each other.

4.4 Special warnings for each target species

The clinical effects of phenylbutazone can be evident for at least three days following cessation of therapy.

This should

be borne in mind when examining horses for soundness.

Some equestrian authorities regard phenylbutazone as a 'prohibited substance'

within their rules.

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4.5 Special precautions for use

Special precaution(s) for use in animals

Do not exceed the stated dose as the therapeutic index of phenylbutazone is low.

Use in any animal less than 6 weeks of age or in aged animals may involve additional risk.

If such use cannot be

avoided animals may require careful clinical management.

Avoid use in any dehydrated, hypovolaemic or hypotensive animal as there is a potential risk of increased renal

toxicity.

NSAID’s can cause inhibition of phagocytosis and hence in the treatment of inflammatory conditions associated with

bacterial infections, appropriate concurrent antimicrobial therapy should be instigated.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Wash hands after use.

Avoid contact with the eyes.

In case of accidental eye contact, irrigate eyes with plenty of clean water.

If irritation

persists seek medical advice.

Care should be taken to avoid inhaling or ingesting the powder.

In the event of accidental inhalation or ingestion seek medical advice and show the product packaging.

4.6 Adverse reactions (frequency and seriousness)

In common with other NSADs that inhibit prostaglandin synthesis, there may be gastric and/or renal intolerance.

This

is usually associated with overdosage and such events are rare.

Recovery is usual on cessation of treatment and

following the initiation of suppportive symptomatic therapy (see 4.10 for further information).

4.7 Use during pregnancy, lactation or lay

Pregnancy:

Care should be exercised if administered to pregnant mares.

Although no adverse effects of phenylbutazone on the

foetus or maintenance of pregnancy have been reported during field use, no definitive safety studies have been carried

out in the mare.

Foetotoxic effects of phenylbutazone have been recorded in experimental animal species at high dose

levels.

Lactation:

Phenylbutazone does not readily cross the blood milk barrier.

If the administration of phenylbutazone to pregnant or lactating mares is considered essential, the potential benefits

should be weighed against the potential hazard to the mare and/or foal.

Avoid use around time of parturition.

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4.8 Interaction with other medicinal products and other forms of interaction

Concurrent administration of potential nephrotoxic drugs should be avoided.

Phenylbutazone is extensively bound to plasma proteins.

It may displace other drugs that are highly protein bound, e.g.

some sulphonomides, warfarin or it may itself be displaced to produce an increase in non-bound pharmacologically

active concentrations, which can lead to toxic effects.

Concurrent therapy with other therapeutic agents should be undertaken with caution due to the risk of metabolic

interactions.

Phenylbutazone may interfere with the metabolism of other drugs, eg warfarin, barbiturates with resultant

toxicity.

There is evidence to indicate that the pharmacokinetics of penicillin products may be affected by concurrent

administration of products containing phenylbutazone, with a possible reduction of therapeutic efficacy, since tissue

penetration may be reduced.

The distribution in other drugs given concurrently may also be affected.

4.9 Amounts to be administered and administration route

Pro-Dynam should be administered by mouth.

For each 450 kg (1000 lbs) bodyweight the following dosage guide should be used according to individual response:

Day 1

Two sachets twice daily (equivalent to 4.4 mg/kg on each occasion).

Day 2-4

One sachet twice daily (equivalent to 2.2 mg/kg on each occasion) followed by one sachet daily (2.2 mg/kg

daily) or on alternate days as required.

If no response is evident after 4-5 days, discontinue treatment. Hay may delay the absorption of phenylbutazone and so

the onset of a clinical effect.

It is advisable not to administer hay immediately prior to, or during the administration of

Pro-Dynam.

For ease of administration Pro-Dynam may be mixed with a quantity of bran or oats.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Overdosing may result in gastric and large intestinal ulceration and general enteropathy.

Renal papillary damage may

also occur with impaired renal function.

Subcutaneous oedema, especially under the jaw, may become evident due to

plasma protein loss.

There is no specific antidote.

If signs of possible overdosage occur, treat the animal symptomatically.

4.11 Withdrawal Period(s)

Not for use in horses intended for human consumption.

Treated horses may never be slaughtered for human consumption.

The horse must have been declared as not intended for human consumption under national horse passport legislation.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids

ATCvet code: QM01AA01

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5.1 Pharmacodynamic properties

Phenylbutazone is a pyrazolone non-steroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory and

antipyretic activiey.

These pharmacodynamic effects are achieved through inhibition of prostaglandin synthesis (cyclo-

oxygenase).

5.2 Pharmacokinetic properties

The plasma elimination half life of phenylbutazone in the horse varies from 3.5 - 8.0 hours.

Normally peak plasma

levels are achieved approximately 2-3 hours after adminsintration.

Oral bioavailability is high but absorption may be

delayed if administered on a full stomach.

Hay in the diet may further delay absorption due to binding and so the onset

of a clinical effect.

Phenylbutazone binds heavily to plasma albumin.

Phenylbutazone is metabolised in the liver to oxphenbutazone, which also has similar pharmacological activity.

Further metabolism takes place to gamma-hydroxyphenylbutazone.

Excretion is mainly via the urine.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Glucose Monohydrate

Methylhydroxypropylcellulose

6.2 Incompatibilities

None known.

6.3 Shelf-life

Shelf-life of the veterinary medicinal product as packaged for sale: 5 years

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

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6.5 Nature and composition of immediate packaging

Paper sachets with an outer lamination of aluminium foil and an inside lamination of polyethylene, containing 5g of

white powder.

Supplied in cartons of 100 sachets.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials

Any unused veterinary medicinal product or waste materials derived from such veterinairy medicinal products should

be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Dechra Veterinary Products A/S

Mekuvej 9

DK-7171 Uldum

Denmark

8 MARKETING AUTHORISATION NUMBER(S)

VPA 10803/001/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

December 2006

10 DATE OF REVISION OF THE TEXT

November 2009

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