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Q7427_vomend_5_mg_ml_s.1_8.tp

Dechra Veterinary Products
Limited
(A business unit of Dechra
Pharmaceuticals PLC)
Sansaw Business Park
Hadnall, Shrewsbury
Shropshire SY4 4AS
Tel: 01939 211200
VOMEND® 5 MG/ML SOLUTION FOR INJECTION
diately and show the package leaflet or the label to FOR DOGS AND CATS
Qualitative and quantitative composition
pyramidal effects (agitation, ataxia, abnormal posi- Metoclopramide (as hydrochloride monohydrate) tions and/or movements, prostration, tremors and 4.457 mg (equivalent to metoclopramide hydro- aggression, vocalisation) have been observed after treatment of dogs and cats. The observed effects are transient and disappear when treatment is stopped.
For a full list of excipients, see Excipients.
In very rare cases, allergic reactions may occur.
Pharmaceutical form
Use during pregnancy and lactation: Laboratory studies in laboratory animals have not produced anyevidence of a teratogenic or foetotoxic effects. How- Clinical particulars
ever, studies on laboratory animals are limited and Target species: Dogs and cats.
the safety of the active substance has not been evaluated in the target species. The use of the product iting and reduced gastrointestinal motility associated during pregnancy and lactation must be made ac- with gastritis, pyloric spasm, chronic nephritis and cording to the benefit/risk assessment carried out by digestive intolerance to some drugs.
testinal perforation or obstruction.
administration of anticholinergic drugs (atropine) asthey may counteract the effects of metoclopramide Special precautions for use in animals: The dosage must be adapted in animals with renal or hepatic In cases of simultaneous diarrhoea, there is no insufficiency (due to an increase in the risk of side contraindication to the use of anticholinergic drugs.
Concurrent use of metoclopramide with neurolep- Avoid administration to animals with epilepsy. The tics derivated from phenothiazine (acepromazine) and dosage should be carefully observed, especially in butyrophenones increases the risk of extrapyramidal effects (see Adverse reactions).
Metoclopramide can potentiate the action of central should be given to fluid and electrolyte replacement nervous system depressants. If used concurrently, it is advised to use the lowest dosage of metoclopram- Special precautions to be taken by the person admin- istering the veterinary medicinal product to ani- Amounts to be administered and administration Intramuscular or subcutaneous use. 0.5 mg metoclopramide hydrochloride per kg body weight, if In case of accidental self-injection, seek medical advice immediately and show the package leaflet orthe label to the physician.
Most of the clinical signs reported after In case of accidental exposure by spillage onto the an overdosage are well known extrapyramidal side skin or eyes, wash immediately with abundant water.
effects (see Adverse reactions). In the absence of a If adverse effects appear, seek medical advice imme- specific antidote, it is recommended to offer a calm environment to the animal until extrapyramidal side Shelf life after first opening the immediate packag- effects disappear. Metoclopramide being rapidly me- tabolised and eliminated, side effects generally dis- Do not use after the expiry date stated on the label Pharmacological
properties Pharmacotherapeutic
package. Keep out of the reach and sight of children.
ATC Vet Code: QA03FA01Pharmacodynamic properties Metoclopramide is an original orthopramide mole- type I, filled with 5, 10, 20, 25, 30 and 50 ml.
cule. The anti-emetic action of metoclopramide is Bromobutyl rubber stoppers type I (the stoppers are mainly due to its antagonist activity at D2 receptors secured with aluminium caps). 1 vial in a cardboard in the central nervous system, preventing nausea and box. Not all pack sizes may be marketed.
vomiting triggered by most stimuli. The prokineticeffect on the gastro-duodenal transit (increase in intensity and rhythm of stomach contractions and or waste materials derived from such veterinary opening of the pylorus) is mediated by muscarinic medicinal products should be disposed of in accor- activity, D2 receptor antagonist activity and 5-HT receptor agonist activity at the gastrointestinal level.
Marketing authorisation holder (if different from
Metoclopramide is rapidly and completely ab- distributor)
sorbed after parenteral administration. After subcu- 25, 5531 AE Bladel, The Netherlands.
taneous administration to dogs and cats, maximum Marketing authorisation number Vm 16849/4020
concentrations are obtained after 15-30 minutes.
Metoclopramide is rapidly distributed into most tis- Date of first authorisation 20.12.2010
sues and fluids, crosses the blood-brain barrier andenters the central nervous system. Metoclopramide Date of revision of the text December 2010
is metabolised by the liver. The elimination of meto-clopramide is rapid, 65% of the dose being eliminated Any other information
within 24 hours in the dog, primarily by the urinary To be supplied only on veterinary prescription.
Manufacturing authorisation holder responsible for batch release: Eurovet Animal Health BV, Handelsweg Pharmaceutical particulars
25, 5531 AE Bladel, The Netherlands.
sodium hydroxide (for pH adjustment), hydrochloric Legal category POM-V
acid (for pH adjustment), water for injections.
GTIN (Global Trade Item No)
Vomend 5 mg/ml Solution for Injection for Dogs and Vomend 5 mg/ml Solution for Injection for Dogs and product as packaged for sale: 2 years.
Requested by: lynne.easton@dechra.com
Approved datasheets found: 1
Creation date: 9/10/2013 14:56:59 (UK)
Approved for book but not on website: 0
Datasheets marked as draft (ignored): 0
Vomend 5 mg/ml Solution for Injection for Directory of participants
Dechra Veterinary Products
Limited
(A business unit of Dechra
Pharmaceuticals PLC)
Sansaw Business Park
Hadnall, Shrewsbury
Shropshire SY4 4AS
Tel: 01939 211200Fax: 01939 211201email: info.uk@dechra.comwww.dechra.com LIST OF PRODUCTS BY THERAPEUTIC INDICATION List of Products by Therapeutic Indication
PHARMACEUTICALS
Enteric preparations
Vomend 5 mg/ml Solution for Injection for Dogs List of Products by Species
Please note that a species in brackets after a product name may not necessarily be a part of that product namebut is intended to make the index easier to use.
Vomend 5 mg/ml Solution for Injection for Dogs and Vomend 5 mg/ml Solution for Injection for Dogs and List of Products by Active Ingredients
This index of non-proprietary names (active ingredients) is provided to enable users of the Compendium toidentify the brand names of relevant products when only the non-proprietary names are known.
It should be noted that although different products may contain the same active ingredient this does not implythat they are equivalent in regard to bioavailability or therapeutic activity.
Some products contain a number of ingredients and it has not been possible in every instance to identify suchproducts by a reference in this index to each ingredient.
Non-proprietary name in bold type. Proprietary name in ordinary type.
Metoclopramide
Vomend 5 mg/ml Solution for Injection for Dogs GRED
IN
E
IV

Alphabetical Index of Products

Source: http://specific-diets.pl/files/dechra/Downloads/Pharma/Datasheets/Vomend_5_mg_ml_Solution_for.pdf%2008-10-2013.pdf

Grant9900-final.pdf

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