Romidys 1 mg/ml Solution for Injection

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.
Premedication
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 intake. Animals,
which
undergo
prolonged
sedation,
should
be
prevented
from
becoming
hypothermic.
Care
should
be
taken
in
animals
in
poor
health,
or
in
cases
of
cardiovascular,
renal,
hepatic
or
pancreatic
disease,
and
in
animals
suffering from respiratory distress. The clinical condition of cats
suffering
from pancreatitis should be closely monitored (see Section 5.9).
ii.
Special precautions to be taken by the person administering the
medicinal
products to animals
This product contains an α
2
-adrenergic agonist.
In the case of 
                                
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