Romidys 1mg/ml Solution For Injection
Country: Ireland
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
13-03-2012
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Active ingredient:
romifidine hypochloride 1 mg
Available from:
Virbac S.A.
ATC code:
QN
Pharmaceutical form:
Solution for injection
Therapeutic group:
NERVOUS SYSTEM
Therapeutic area:
Cats Non Food, Dogs Non Food
Authorization date:
2011-02-25
Summary of Product characteristics
Revised: February 2011
AN: 01019/2010
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Romidys 1 mg/ml solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of Romidys 1 mg/ml solution for injection contains:
ACTIVE INGREDIENT
Romifidine hydrochloride
1 mg
equivalent to 0.876 mg romifidine
PRESERVATIVES
Methyl parahydroxybenzoate
(E218)
1.8 mg
Propyl parahydroxybenzoate
(E216)
0.2 mg
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear almost colorless solution
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Sedative for use in dogs and cats for restraint; to facilitate handling, clinical
examinations, minor surgical interventions and manipulations. Premedicati on
agent prior to the induction of general anaesthesia. For profound
sedation/analgesia in dogs it may also be used with an opioid analgesic. In cats
combination with ketamine provides surgical anaesthesia.
4.3 CONTRAINDICATIONS
Do not use in pregnant animals.
Do not use in animals suffering from diabetes mellitus.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
As a dose-dependent increase in blood urea may occur in cats, sufficient fluid
intake should be ensured.
Revised: February 2011
AN: 01019/2010
Page 2 of 7
4.5 SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Sedated animals should be restrained to prevent injury. Care should be
taken to ensure that animals have sufficient fluid
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