Country: Austria
Language: English
Source: HMA (Heads of Medicines Agencies)
metoclopramide hydrochloride 5.27 mg/ml
Eurovet Animal Health
QA03FA01
Solution for injection
metoclopramide
Cats Non Food, Dogs Non Food
2010-11-15
1/13 ANNEX III LABELLING AND PACKAGE LEAFLET 2/13 A. LABELLING 3/13 PARTICULARS TO APPEAR ON THE OUTER PACKAGE 5, 10, 20, 25, 30 AND 50 ML 1. NAME OF THE VETERINARY MEDICINAL PRODUCT VOMEND 5 mg/ml solution for injection for dogs and cats Metoclopramide hydrochloride (Austria, Germany, Italy, Luxembourg, Portugal, The Netherlands, United Kingdom) VOMEND ANTI-EMETICUM solution for injection Metoclopramide hydrochloride (France) VOMEND ANTI-EMETICUM 5 mg/ml solution for injection for dogs and cats Metoclopramide hydrochloride (Belgium, Spain) Vomend Vet. 5 mg/ml solution for injection for dogs and cats Metoclopramide hydrochloride (Finland, Sweden) 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES 1 ml contains: Metoclopramide (as hydrochloride monohydrate) 4.457 mg equivalent to metoclopramide hydrochloride 5 mg Benzyl alcohol (E1519) 18 mg 3. PHARMACEUTICAL FORM Solution for injection 4. PACKAGE SIZE 5, 10, 20, 25, 30 and 50 ml 5. TARGET SPECIES Dogs, cats 6. INDICATION(S) Read the package leaflet before use. 7. METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular or subcutaneous use. 8. WITHDRAWAL PERIOD 4/13 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. 10. EXPIRY DATE EXP: {month/year} Once opened, use by ___/___/___ Shelf-life after first opening: 28 days. 11. SPECIAL STORAGE CONDITIONS Read the package leaflet before use. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIAL Read the complete document
1/5 1 PART 1B-1 SUMMARY OF PRODUCT CHARACTERISTICS 2/5 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vomend 5 mg/ml solution for injection for dogs and cats (Austria, Germany, Italy, Luxembourg, Portugal, The Netherlands, United Kingdom) VOMEND ANTI-EMETICUM solution for injection (France) VOMEND ANTI-EMETICUM 5 mg/ml solution for injection for dogs and cats (Belgium, Spain) Vomend Vet. 5 mg/ml solution for injection for dogs and cats (Finland, Sweden) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Metoclopramide (as hydrochloride monohydrate) 4,457 mg equivalent to metoclopramide hydrochloride 5 mg EXCIPIENTS: Benzyl alcohol (E1519) 18 mg For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection. Clear colourless aqueous solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Symptomatic treatment of vomiting and reduced gastro-intestinal motility associated with gastritis, pyloric spasm, chronic nephritis and digestive intolerance to some drugs. 4.3 CONTRAINDICATIONS Do not use in cases of gastro-intestinal perforation or obstruction. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 3/5 3 4.5 SPECIAL PRECAUTIONS FOR USE 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 epilepsy. The dosage should be carefully observed, especially in cats a Read the complete document