Rompun Dry Substance 500 mg Powder and Solvent for 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:

Horses, Zoo Animals

Therapeutic area:

Neurological Agent sedative

Authorization status:

Expired

Authorization date:

1993-08-20

Summary of Product characteristics

Revised: June 2011
AN: 00335/2011
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Rompun Dry Substance
500 mg Powder and Solvent for Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE CONSTITUENTS
MG PER VIAL
Xylazine
(as Xylazine hydrochloride
500
583)
RELEVANT CONSTITUENTS OF THE EXCIPIENTS
Solvent for use with Rompun Dry Substance is Water for Injection 10 ml
per vial.
For full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses, Zoo animals
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For use in horses and zoo animals where sedation is required,
including,
1.
Handling fractious animals e.g. for transportation
2.
Medical examinations e.g. X-ray examination, removal of bandages,
examination of teats, penis and oral cavity
3.
Pre-medication for minor superficial operations, painful manipulative
procedures and local or regional anaesthesia.
4.3
CONTRAINDICATIONS
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.
Revised: June 2011
AN: 00335/2011
Page 2 of 7
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Caution is required when pulmonary disease is present or suspected. In
recumbent ruminants, tympany should be prevented by maintaining
sternal
recumbency. For operations on ruminants in lateral or dorsal
recumbency it is
advisable to lower the head and neck in order to avoid inhalation of
saliva or
ruminal fluids. Following intravenous injection in horses, there is a
transient rise
followed by a fall in blood pressure.
Transient hyperglycaemia is a common finding after Rompun sedation.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
With horses and zoo animals the usual precautions required for
handling
should always be observed