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Prascend 1mg Tablets x 60 Pack PRESCRIPTION REQUIRED

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£75.56
SKU:
333918-1
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Product Description

Prascend can be sold in any quantity.Please contact us on 0845 519 1093 to place your order if you require less than x 60 tablet pack

Prascend 1 mg tablets for horsesfor the treatment of clinical signs associated with Pituitary Pars Intermedia Dysfunction, PPID (Equine Cushing’s Disease).

Introduction

Address: Ellesfield Avenue

Bracknell

Berkshire RG12 8YS

Telephone: Sales & Marketing Enquiries 01344 746959

Telephone: Technical Enquiries 01344 746957

Fax: 01344 741349

Presentation

Tablet - Pink, modified rectangular shape scored tablet, engraved on one side the Boehringer Ingelheim logo and the letters “PRD” and contains 1.0 mg pergolide (as pergolide mesylate 1.31 mg)

Uses

For the treatment of clinical signs associated with Pituitary Pars Intermedia Dysfunction, PPID (Equine Cushing’s Disease).

Dosage and administration

Administer orally, once daily, at an average starting dose of 2 µg/kg bodyweight. Studies from the published literature cite the most common, average dose as 2 µg /kg with a range from 0.25 mg - 5 mg total daily dose per horse (0.6 – 10 µg/kg). The starting dose (2 µg/kg) should then be titrated according to the individual response as determined by monitoring (see below). Practical starting doses are recommended as follows:

Horse Body Weight

Starting Dose

Dosage Range

Number of Tablets

200 - 400 kg

0.5 mg

1.3 - 2.5 μg/kg

½

400 - 600 kg

1.0 mg

1.7 - 2.5 μg/kg

1

301 - 850 kg

1.5 mg

1.8 - 2.5 μg/kg

1 ½

851 - 1000 kg

2.0 mg

2.0 - 2.4 μg/kg

2

Tablets may be administered orally by dissolving the tablet with a small amount of water and/or mixing with molasses or other sweetener; taking care to rinse the dosing apparatus with water to ensure entire dose is administered; use immediately. Most horses respond to therapy and are stabilised at an average dose of 2 µg/kg. Clinical improvement with pergolide is expected within 6 to 12 weeks. Some horses may respond clinically at lower or varying doses, and it is recommended to titrate to the lowest effective dose per individual based on response to therapy, whether it is effectiveness or signs of intolerance. A small number of horses may require doses as high as 10 µg/kg per day. In these rare situations, appropriate additional monitoring should be implemented.

Monitoring and dose titration

Pre-treatment samples should be taken for appropriate diagnostic endocrinologic laboratory tests (e.g., serum or plasma ACTH or serum cortisol response to the low-dose dexamethasone suppression test) to diagnosis disease, monitor treatment, and for dose titration. Following initial diagnosis, repeat samples should be taken for endocrinologic testing for dose titration and monitoring of treatment at intervals of 6 weeks until stabilisation of clinical signs and/or diagnostic testing occurs. The approach to treatment is to titrate to the lowest effective dose per individual based on response to therapy, whether it is effectiveness or signs of intolerance. Dose titration is based on clinical sign improvement (e.g., hirsutism, polyuria, polydipsia, muscle wasting, abnormal fat distribution, chronic infections, etc.), and/or diagnostic testing improvement/normalisation (e.g., serum ACTH or serum cortisol response to the low-dose dexamethasone suppression test). Depending on the severity of the disease, time to treatment response may vary among individuals. For example, if clinical signs are not improving or if the diagnostic testing has not yet normalised at the first 6 week interval, the total daily dose may be increased by 0.5 mg. Some individuals may be improving but not yet normalised/stabilised and their dose may or may not need to be titrated based on the veterinarian’s discretion and the individual’s response/tolerance to the drug dose.Should clinical signs not be adequately controlled (based on clinical evaluation and/or diagnostic testing) consideration should be given to increasing the total daily dose by 0.5 mg increments every 6 weeks until stabilisation occurs and if the drug is tolerated at that dose. If signs of dose intolerance develop, treatment should be stopped for 2-3 days and reinstituted at one-half the previous dose. The total daily dose may be then be titrated back up to the desired clinical effect by 0.5 mg increments every 2-4 weeks. If a dose is missed, the next scheduled dose should be administered as prescribed. Following stabilisation, regular clinical assessment and diagnostic testing should occur every 6 months to monitor treatment and dose.

Contra-indications, warnings, etc

Do not use in horses with hypersensitivity to pergolide mesylate or other ergot derivatives.

Do not use in horses less than 2 years of age.

Appropriate endocrinologic laboratory tests (e.g., serum ACTH or serum cortisol response to the low-dose dexamethasone suppression test) should be conducted as well as evaluation of clinical signs in order to establish a diagnosis of PPID.

Potential adverse reactions in horses include inappetence, transient anorexia and lethargy, mild central nervous system signs (e.g., mild depression and mild ataxia), diarrhoea and colic. If signs of dose intolerance develop, treatment should be stopped for 2-3 days and then reinstituted at one-half of the previous dose. The total daily dose may be then be titrated back up until the desired clinical effect is achieved, increasing in 0.5 mg increments every 2-4 weeks.

Use only according to the benefit/ risk assessment by the responsible veterinarian during pregnancy. The safety has not abeen shown in pregnant mares. Laboratory studies in mice and rabbits have not produced any evidence of teratogenic effects. At higher doses, reduced fertility was seen in mice. The safety has not been shown in lactating horses. In mice, reduced body weights and survival rates in the progeny were attributed to the pharmacological inhibition of prolactin secretion resulting from lactation failure.

Pergolide mesylate is approximately 90% bound to plasma proteins in humans and laboratory animals; caution should be exercised if it is co-administered with other drugs known to affect protein binding.

Dopamine antagonists, such as neuroleptics (phenothiazines), domperidone, or metoclopramide ordinarily should not be administered concurrently with pergolide mesylate (a dopamine agonist); these agents may diminish the effectiveness of pergolide mesylate.

There is no clinical experience with massive overdose.

Withdrawal period

Not authorised 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. Not authorised for use in mares producing milk for human consumption.

User precautions:

User precautions

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Do not induce vomiting. Pergolide mesylate should not be administered by persons who have had adverse reactions to ergotamine or other ergot derivatives. Breaking tablets will result in an increased opportunity for exposure to the active ingredient. It has been reported that pergolide tablets may cause eye irritation, an irritating smell, or headache when tablets are split or crushed. Caution is advised to minimise exposure risks when splitting tablets, and tablets should not be crushed. In case of contact with skin, wash exposed place with water. In the event of pergolide exposure to the eye, the affected eye should be flushed immediately with water, and medical advice obtained. For nasal irritation, move to fresh air and obtain medical attention if breathing difficulty develops. Pregnant or lactating women should wear gloves when administering the product

Pharmaceutical precautions

Dispose of any unused product and empty packaging in accordance with guidance from your local waste regulation authority.

Do not store above 25°C.

Store the blister in the original carton.

Keep out of reach and sight of children.

Legal category

POM-V

Packaging Quantities

Prascend tablets are packed in cold-formed aluminium blisters, containing each 10 tablets. The forming material is nylon/ aluminium foil/ UPVC. The lidding material is aluminium foil with a vinyl heat seal coating.

Further information

Nil

Marketing authorisation number

Vm 00015/4081.

Significant Changes

Prascend 1 mg tablets for horses

Boehringer Ingelheim Limited

New Product

06/09/2010

GTIN (Global Trade Item No)

Other Details

Policy number:

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Product Reviews

  1. prascend

    Posted by Avril Yard on 9th Mar 2014

    I am now finding that the tablets my horse is on are doing him good, he is looking good and his coat isnt too bad this winter.


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Animal Dispensaries Ltd, Unit 19, Macmerry Industrial Estate, Macmerry, East Lothian. EH33 1RD. Resident Vet: Ms Iona Warren