Rompun 2% w/v Solution for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Xylazine

Available from:

Bayer plc

ATC code:

QN05CM92

INN (International Name):

Xylazine

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Cattle, Dogs, Horses

Therapeutic area:

Neurological Agent sedative

Authorization status:

Authorized

Authorization date:

1995-12-14

Summary of Product characteristics

Revised: May 2017
AN: 00069/2017
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Rompun 2% w/v Solution for Injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance(s)
Xylazine hydrochloride
2.332g/100ml
(equivalent to 2.0g/100ml xylazine base)
Excipients
Methyl hydroxybenzoate (E218)
0.150g/100ml
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, horses, dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Sedative with some analgesic and muscle relaxant properties for use in
cattle,
horses, dogs and cats.
All cases where sedation is required including:
i)
Handling fractious animals (e.g. for transportation).
ii)
Medical examination e.g. X-ray examination, removal of bandages,
examination of teats, penis and oral cavity.
iii)
Pre-medication for minor superficial operations, painful manipulative
procedures and local or regional anaesthesia.
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Revised: May 2017
AN: 00069/2017
4.3
CONTRA-INDICATIONS
Do not use in the latter stages of pregnancy except at parturition. As
the safety
of xylazine use during organogenesis has not been fully demonstrated
by current
methods it should be used with caution during the first month of
pregnancy.
In the cat and dog, because of the emetic effect which is sometimes
produced,
do not use xylazine in mechanical complications of the alimentary
tract e.g.
obstruction of the oesophagus, gastric torsion or hernia.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
_Applicable to all species_
Use with care in elderly or debilitated patients which may be
adversely affected
by profound cardiovascular changes.
_Cattle_
Tympany should be prevented in recumbent cattle by sternal recumbency.
For operations in lateral or dorsal recumbency, lower head and neck to
prevent
inhalation of ruminal contents.
Maintain recumbent and drowsy animals in the shade. In case of
accidental
overdosage leading to respiratory failure, cold water douches and
arti