VOMEND 5 mg/ml inj. for dog and cat
Country: Netherlands
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
04-05-2013
Summary of Product characteristics
(SPC)
04-05-2013
Active ingredient:
metoclopramide hydrochloride 5.27 mg/ml
Available from:
Eurovet Animal Health
ATC code:
QA03FA01
Pharmaceutical form:
Solution for injection
Therapeutic group:
metoclopramide
Therapeutic area:
Cats Non Food, Dogs Non Food
Authorization date:
2010-11-15
Patient Information leaflet
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
Summary of Product characteristics
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
