Metomotyl 5 mg/ml Solution for Injection for Cats and Dogs

Composition

Each ml contains:

Active substance:

Metoclopramide 4.457 mg equivalent to metoclopramide hydrochloride 5 mg

Excipients:

Metacresol 2 mg

For the full list of excipients, see section 6.1.

6.1 List of excipients

Metacresol

Sodium chloride

Water for injections

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Pharmaceutical form

Solution for injection.

Clear colourless solution.

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Pharmacological properties

Pharmacotherapeutic group: drugs for functional gastro-intestinal disorders, propulsives

ATCvet code: QA03FA01

5.1 Pharmacodynamic properties

Metoclopramide is an original orthopramide molecule.

The anti-emetic action of metoclopramide is mainly due to its antagonist activity at D2 receptors in the central nervous system, preventing nausea and vomiting triggered by most stimuli.

The prokinetic effect on the gastroduodenal transit (increase in intensity and rhythm of stomach contractions and opening of the pylorus) is mediated by muscarinic activity, D2 receptor antagonist activity and 5-HT4 receptor agonist activity at the gastro-intestinal level.

5.2 Pharmacokinetic particulars

Metoclopramide is rapidly and completely absorbed after parenteral administration.

After subcutaneous administration to dogs and cats, maximum concentrations are obtained after 15-30 min.

Metoclopramide is rapidly distributed into most tissues and fluids, crosses the blood-brain barrier and enters the central nervous system.

Metoclopramide is metabolised by the liver.

The elimination of metoclopramide is rapid, 65% of the dose being eliminated within 24 hours in the dog, primarily by the urinary route.

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Target species

Cats and dogs

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Indications

Symptomatic treatment of vomiting and reduced gastro-intestinal motility associated with gastritis, pyloric spasm, chronic nephritis and digestive intolerance to some drugs. Prevention of vomiting after surgery.

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Dosage

Intramuscular or subcutaneous use

0.5 to 1 mg of metoclopramide hydrochloride per kg of body weight per day by intramuscular or subcutaneous routes, divided in 2 or 3 administrations:

- for twice daily administration: 2.5 to 5 mg/10 kg of body weight per injection i.e. 0.5 to 1 ml/10 kg of body weight per injection.

- for administration 3 times a day: 1.7 to 3.3 mg/10 kg of body weight per injection i.e. 0.34 to 0.66 ml/10 kg of body weight per injection.

The interval between two administrations should be at least 6 hours.

The stopper should not be punctured more than 20 times.

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Contraindications

Do not use in cases of:

- gastro-intestinal perforation or obstruction.

- gastro-intestinal hemorrhage

- hypersensitivity to the active substance or to any of the excipients.

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Adverse reactions

Dogs:

Very rare (<1 animal / 10,000 animals treated, including isolated reports):

Extrapyramidal effects (agitation, ataxia, abnormal positions and/or movements, prostration, tremors and aggression, vocalisation)*

Allergic reaction

*The observed effects are transient and disappear when treatment is stopped.

Cats:

Very rare (<1 animal / 10,000 animals treated, including isolated reports):

Extrapyramidal effects (agitation, ataxia, abnormal positions and/or movements, prostration, tremors and aggression, vocalisation)*

Allergic reaction

Drowsiness

Diarrhoea

*The observed effects are transient and disappear when treatment is stopped.

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Warnings

Special precautions for use in animals

The dosage must be adapted in animals with renal or hepatic insufficiency (due to an increase in the risk of side effects).

Avoid administration to animals with seizure disorders or head trauma. Avoid in dogs with pseudopregnancy.

Avoid administration to animals with epilepsy. The dosage should be carefully observed, especially in cats and small breed dogs.

In animals with pheochromocytoma, metoclopramide may induce a hypertensive crisis.

Following prolonged vomiting, consideration should be given to fluid and electrolyte replacement therapy.

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

Wash hands after administration to the animal.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

In case of accidental spillage onto skin or eyes, wash immediately with abundant water. If adverse effects appear, seek medical advice immediately and show the package leaflet or the label to the physician.

Special precautions for the protection of the environment

Not applicable.

Other precautions:

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

Laboratory studies in laboratory animals have not produced any evidence of teratogenic or foetotoxic effects.

However, studies on laboratory animals are limited and the safety of the active substance has not been evaluated in the target species. Use only according to the benefit/risk assessment by the responsible veterinarian.

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Interactions

In cases of gastritis, avoid the co-administration of anticholinergic drugs (atropine) as they may counteract the effects of metoclopramide on gastro- intestinal motility.

In cases of simultaneous diarrhoea, there is no contraindication to the use of anticholinergic drugs.

Concurrent use of metoclopramide with neuroleptics derived from phenothiazine (acepromazine) and butyrophenones increases the risk of extrapyramidal effects (see section 4.6).

Metoclopramide can potentiate the action of central nervous system depressants. If used concurrently, it is advised to use the lowest dosage of metoclopramide to avoid excessive sedation.

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Overdose

Most of the clinical signs reported after an overdosage are well-known extrapyramidal side effects (see section 4.6).

In the absence of a specific antidote, it is recommended to offer a calm environment to the animal until extrapyramidal side effects disappear. Metoclopramide being rapidly metabolised and eliminated, side effects generally disappear quickly.

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Special warnings

None

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Withdrawal period

Not applicable.

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Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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Immediate packaging

Nature of container:

Clear colourless type I glass vial

Red chlorobutyl 20 mm stopper

Aluminium 20 mm cap

Pack size:

Cardboard box containing 1 vial of 5, 10, 20, 25, 30 or 50 mL

Not all pack sizes may be marketed.

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Storage

Keep the vial in the outer carton in order to protect from light.

Do not freeze.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

Shelf life after first opening the immediate packaging: 28 days

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Disposal of unused product

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. Medicines should not be disposed of via wastewater.

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Additional information

Vm 41821/5014

9 DATE OF FIRST AUTHORISATION

09 September 2014

10 DATE OF REVISION OF THE TEXT

December 2023

11 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ or ‘PID’ on www.gov.uk.

Approved: 13 March 2024

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Registration holder

Le Vet Beheer B.V.

Wilgenweg 7

3421 TV Oudewater

The Netherlands

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