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GastroGard 37% w/w oral paste for horses

Item Number: GASTROGARD

GastroGard 37% w/w oral paste for horses

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Description

GastroGard 37% w/w oral paste for horses.

Uses
For treatment and prevention of gastric ulcers in horses, including foals from 4 weeks old.

Dosage and administration
GASTROGARD is effective in horses of various breeds and under different management conditions, foals as young as four weeks of age and weighing over 70 kg, and breeding stallions. For oral administration.

Treatment of gastric ulcers: one administration per day during 28 consecutive days at the dose rate of 4 mg omeprazole per kg body weight followed immediately by a dosage regimen of one administration per day during 28 consecutive days at the dose rate of 1 mg omeprazole per kg body weight, to reduce the recurrence of gastric ulcers during treatment.

Should recurrence occur (confirmed by gastroscopy), re-treatment at a dose rate of 4 mg omeprazole per kg body weight is recommended.

Prevention of gastric ulcers: one administration per day at the dose rate of 1mg omeprazole per kg body weight.

Packaging Quantities
Carton box of 1 or 14 syringes.

GastroGard 37% w/w oral paste for horses.

Uses
For treatment and prevention of gastric ulcers in horses, including foals from 4 weeks old.

Dosage and administration
GASTROGARD is effective in horses of various breeds and under different management conditions, foals as young as four weeks of age and weighing over 70 kg, and breeding stallions. For oral administration.

Treatment of gastric ulcers: one administration per day during 28 consecutive days at the dose rate of 4 mg omeprazole per kg body weight followed immediately by a dosage regimen of one administration per day during 28 consecutive days at the dose rate of 1 mg omeprazole per kg body weight, to reduce the recurrence of gastric ulcers during treatment.

Should recurrence occur (confirmed by gastroscopy), re-treatment at a dose rate of 4 mg omeprazole per kg body weight is recommended.

Prevention of gastric ulcers: one administration per day at the dose rate of 1mg omeprazole per kg body weight.

Packaging Quantities
Carton box of 1 or 14 syringes.


Data Sheets

GastroGard 370 mg/g oral paste Species:Horses and other equidae

Therapeutic indication:Pharmaceuticals: Enteric preparations

Active ingredient:Omeprazole

Product:GastroGard 370 mg/g oral paste

Product index:GastroGard

Withdrawal notes:Horse: Meat and offal: 1 day. Not permitted for use in mares producing milk for human consumption.

Qualitative and quantitative composition

Each gram contains:

Active substance: Omeprazole 370 mg

Excipient: Yellow iron oxide (E172) 2 mg

For the full list of excipients, see below.

Pharmaceutical form

Oral paste. Smooth homogeneous yellow to yellow-tan paste.

Clinical particulars

Target species

Horses.

Indications for use

For treatment and prevention of gastric ulcers.

Contra-indications

Do not use in mares producing milk for human consumption.

Special warnings for each target species

None.

Special precautions for use in animals

Not recommended for animals under 4 weeks of age or weighing less than 70 kg bodyweight. Stress (including high performance training and competition), feeding, management and husbandry practices may be associated with the development of gastric ulceration in horses. Individuals responsible for the well-being of horses should consider reducing the ulcerogenic challenge by modifying husbandry practices to achieve one or more of the following: reduced stress, reduced fasting, increased intake of roughage and access to grazing.

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

As this product may cause hypersensitivity, avoid direct contact with skin and eyes. Use impervious gloves and do not eat or drink when handling and administering the product. Wash hands or any exposed skin after use. In case of contact with eyes, wash immediately with clean running water and seek medical advice. Persons developing a reaction after contact with the product should avoid handling the product in future.

Adverse reactions

None known

Use during pregnancy, lactation or lay

Laboratory studies in rats and rabbits have not produced any evidence of a teratogenic effect.

In the absence of data during pregnancy and lactation, the use of GastroGard in pregnant and lactating mares is not recommended.

Interactions

Omeprazole may delay the elimination of warfarin. No other interaction with medicines routinely used in the treatment of horses is expected, although interaction with drugs metabolised by liver enzymes cannot be excluded.

Amounts to be administered and administration route

GastroGard is effective in horses of various breeds and under different management conditions; foals as young as four weeks and weighing over 70 kg; and breeding stallions.

For oral administration.

Treatment of gastric ulcers: One administration per day during 28 consecutive days at the dose rate of 4 mg omeprazole per kg bodyweight followed immediately by a dosage regimen of one administration per day during 28 consecutive days at the dose rate of 1 mg omeprazole per kg bodyweight, to reduce the recurrence of gastric ulcers during treatment. Should recurrence occur, re-treatment at a dose rate of 4 mg omeprazole per kg body weight is recommended.

It is recommended that treatment is combined with changes of husbandry and training practices (please see Special precautions for use in animals).

Prevention of gastric ulcers: One administration per day at the dose rate of 1 mg omeprazole per kg bodyweight.

To deliver GastroGard at the dose of 4 mg omeprazole/kg, set the syringe plunger to the appropriate dose division for the horse’s weight. Each full dose division on the syringe plunger delivers sufficient omeprazole to treat 100 kg bodyweight. The contents of one syringe will treat a 575 kg horse at the rate of 4 mg omeprazole per kg bodyweight.

To deliver GastroGard at the dose of 1 mg omeprazole/kg, set the syringe plunger to the dose division equivalent to one quarter of the horse’s bodyweight. At this dose, each full dose division on the syringe plunger will deliver sufficient omeprazole to treat 400 kg body weight. For example, to treat a horse weighing 400 kg, set the plunger to 100 kg.

Replace cap after use.

Overdose

No undesirable effects related to treatment were observed following daily use for 91 days at omeprazole dosages up to 20 mg/kg in adult horses and in foals older than 2 months.

No undesirable effects related to treatment (in particular no adverse effect on the semen quality or reproductive behaviour) were observed following daily use for 71 days at an omeprazole dosage of 12 mg/kg in breeding stallions.

No undesirable effects related to treatment were observed following daily use for 21 days at an omeprazole dosage of 40 mg/kg in adult horses.

Withdrawal periods

Meat and offal: 1 day. Not permitted for use in mares producing milk for human consumption.

Pharmacological particulars

Pharmacotherapeutic group

Drugs for peptic ulcer, Proton pump inhibitors.

ATCvet code: QA02BC01

Pharmacodynamic particulars

In studies lasting up to 28 days, treatment with GastroGard at the dose rate of 1 mg omeprazole per kg body weight per day has been shown to help prevent the occurrence of gastric ulcers in horses exposed to ulcerogenic conditions.

Omeprazole is a proton pump inhibitor belonging to the substituted benzimidazole class of compounds. It is an antacid, for treatment of peptic ulcers.

Omeprazole suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase enzyme system at the secretory surface of the parietal cell. The H+/K+- ATPase enzyme system is the acid (proton) pump within the gastric mucosa. Because H+/K+- ATPase is the final step involved in control of acid secretion, omeprazole blocks secretion irrespective of the stimulus. Omeprazole irreversibly binds to the gastric parietal cell H+/K+-ATPase enzyme that pumps hydrogen ions into the lumen of the stomach in exchange for potassium ions.

At 8, 16 and 24 hours after dosing horses with omeprazole at 4 mg/kg/day orally, pentagastrin-stimulated gastric acid secretion was inhibited by 99%, 95% and 90% and basal secretion was inhibited by 99%, 90% and 83%.The full effect on the inhibition of acid secretion is reached by five days after the first administration.

Pharmacokinetic particulars

The median bioavailability of omeprazole after oral administration as a paste is 10.5% (range 4.1 to 12.7%). The absorption is rapid with time to maximum plasma concentrations (Tmax) of approximately one hour after dosing. Mean peak concentration (Cmax) ranges from 385 ng/ml to 693 ng/ml after dosing with 4 mg/kg. There is a significant first-pass effect following oral administration. Omeprazole is rapidly metabolised principally into glucuronides of demethylated and hydroxylated omeprazole sulphide (urinary metabolites) and methyl sulphide omeprazole (biliary metabolite) as well as into reduced omeprazole (both). After oral administration at 4 mg/kg, omeprazole is detectable in plasma for 9 hours after treatment, and in urine as hydroxyomeprazole and O-desmethylomeprazole at 24 hours but not at 48 hours. Omeprazole is eliminated quickly, mainly by urinary route (43 to 61% of the dose), and to a smaller extent by faecal route, with a terminal half-life ranging from approximately 0.5 to 8 hours.

After repeated oral administration, there is no evidence of accumulation.

Pharmaceutical particulars

Excipients

Yellow iron oxide (E172), Monoethanolamine, Potassium sorbate, Cassia oil, Sodium stearate, Calcium stearate, Hydrogenated castor oil, Propylene glycol octanoate decanoate, Sesame oil.

Major incompatibilities

Not applicable.

Shelf life

Shelf life of the product as packaged for sale: 18 months.

Shelf life after first opening the immediate packaging: 28 days.

Special precautions for storage

Do not store above 30 °C. Replace cap after use.

Immediate packaging

Carton box of 1, 7 or 14 syringes.

Disposal

Any unused product or waste materials derived from such products should be disposed of in accordance with local requirements.

Marketing Authorisation Number

Vm 08327/4205

Significant changes

Legal category

Legal category:POM-V

GTIN

GTIN description:GastroGard 370 mg/g oral paste Carton box of x 1 syringe

GTIN:3661103041672

GTIN description:GastroGard 370 mg/g oral paste Carton box of x 7 syringes

GTIN:3661103020967

GTIN description:GastroGard 370 mg/g oral paste Carton box of x 14 syringes

GTIN:3661103042792

Delivery

Shipping charges mainland UK zone1

ValueWeightDelivery Charge
Over £49.00Any WeightFREE
Under £49.00No weight limit£4.50
Under £49.00Under 250g£2.99

Most orders are despatched the same day and standard delivery is 3 to 5 working days from despatch. FAST Expedited options are available.

NB: Orders placed with faster delivery must be placed before 13:00 to ensure same day dispatch (excluding weekends and bank holidays). Please also check on the product page that the items ordered show 'In Stock' otherwise your order will be delayed until the stock becomes available, which in most cases will only be 24hrs.

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Overseas orders

Postage outside of the UK is from £4.50

Prescription Items

Prescription items will be sent on receipt of a valid signed and dated prescription.

Pick up

We offer a pickup service for orders placed over the phone.

Please ring us on 01833 641112 for more information.

Refrigerated Items

Refrigerated items will be sent by carrier or Royal Mail with coolpacks unless you pay for a premium for a refrigerated delivery. We will contact you prior to despatch for your instructions.

Returns

We want you to be completely satisfied with any purchase. If not any item* can be returned to us within 14 days of receipt for exchange or refund Please give us a ring for a returns number on 01833 641112 or alternatively email [email protected] to obtain a returns number.

*Due to legal requirements medicines may not be returned except to correct an error in despatch or in response to an "official recall". If an item is believed to be faulty it should be returned for inspection and it may be necessary to forward it to the manufacturers for testing before replacements or refunds can be authorised. This does not infringe legal rights. Please contact our customer services for a "Returns Number" which must appear on the outside of the package or it will not be accepted. We advise customers to use an insured method of shipping and to retain proof of despatch. We may refuse returns on products specially obtained or manufactured to order. Items must be returned unsoiled and unused and sent adequately packed and carriage paid.

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