Birp Oral Emulsion for Cattle

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Simethicone

Available from:

Alfasan Nederland B.V.

ATC code:

QA16Q

INN (International Name):

Simethicone

Pharmaceutical form:

Oral emulsion

Prescription type:

AVM-GSL - Authorised Veterinary Medicine – General Sales List

Therapeutic group:

Cattle

Therapeutic area:

Gastrointestinal antibloat

Authorization status:

Authorized

Authorization date:

1994-03-30

Summary of Product characteristics

Revised: August 2021
AN: 00888/2021
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Birp Oral Emulsion for Cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Qualitative composition
Simethicone
EXCIPIENTS
Sodium propyl hydroxybenzoate
Sodium methyl hydroxybenzoate
For a full list of excipients, see
section 6.1.
Quantitative composition % w/v
1.00
0.05
0.15
3.
PHARMACEUTICAL FORM
Oral emulsion.
A white emulsion of Simethicone.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the relief of gaseous and frothy bloat in cattle.
4.3
CONTRAINDICATIONS
None known.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Secondary or free-gas bloat most often occurs in single animals, in
which
there is obstruction of eructation. In such cases, treatment should be
supported by veterinary diagnosis of the cause of the failure of
eructation.
In outbreaks of primary frothy bloat, management strategies should be
introduced to reduce foam production in the rumen or to control access
of
cattle to pasture or grains that promote excess gaseous foams.
Revised: August 2021
AN: 00888/2021
Page 2 of 4
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Use the container on one occasion only; discard it and any remaining
contents after use.
ii.
Special precautions for the person administering the veterinary
medicinal
product to animals
Wash hands after use.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
No special precautions.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.9
AMOUNT(S) TO BE ADMINISTERED AND ADMINISTRATION ROUTE
By oral administration, 50 to 100 ml. A second dose may be given 3
hours
later if required.
4.10
OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES), IF NECESSARY
Not known.
4.11
WITHDRAWAL PERIOD(S)
Meat: Zero days
Milk: Zero hours
5.
PHARMACOLOGICAL PROPERTIES
PHARMACOTHERAPEUTIC