Birp Oral Emulsion for Cattle
Simethicone
Last verified
Veterinary medicinal product: oral emulsion. Distribution category: AVM-GSL (Veterinary Medicines Regulations 2013, Schedule 3). Active substance: Simethicone.1
In short: questions and answers
- Does Birp Oral Emulsion for Cattle need a prescription?
- Over the counter. As stated in the registration decision.1
- Which animals is Birp Oral Emulsion for Cattle for?
- Cattle.1
- What is the active substance in Birp Oral Emulsion for Cattle?
- Simethicone. ATCvet code: QA16Q.13
- What is the withdrawal period of Birp Oral Emulsion for Cattle according to the leaflet?
- Cattle, meat: 0 days; Cattle, milk: 0 days.3
- Dispensing
- Over the counter1
AVM-GSL: Authorised Veterinary Medicine - General Sale List. No prescription is needed and it may be sold by any retailer.12
Supplied without a prescription. As stated in the registration decision.
- Animal species
- Cattle1
- Active substance
- Simethicone
- ATCvet code
- QA16Q3
- Manufacturer
- Marketing authorisation holder: Alfasan Nederland B.V.
Withdrawal period
Summary of product characteristics
Composition
Active substance
| Qualitative composition | Quantitative composition % w/v |
|---|---|
| Simethicone | 1.00 |
| Excipients | |
| Sodium propyl hydroxybenzoate | 0.05 |
| Sodium methyl hydroxybenzoate | 0.15 |
For a full list of excipients, see section 6.1.
6.1 List of excipients
Sodium propyl hydroxybenzoate
Sodium methyl hydroxybenzoate
Glycerol monostearate (self emulsifying)
Dilute hydrochloric acid (for pH adjustment)
Water, purified
Pharmaceutical form
Oral emulsion.
A white emulsion of Simethicone.
Pharmacological properties
Pharmacotherapeutic group
Other alimentary tract and metabolism products, other alimentary tract and metabolism products for veterinary use, Drugs for treatment of acetonemia
ATC Vet Code
QA16Q
5.1 Pharmacodynamic properties
The product is not pharmacologically active, and acts locally in the rumen of cattle by changing the surface tension of small gas bubbles trapped in foam, causing them to coalesce.
Simethicone (activated dimethicone, activated polymethylsiloxane) is used widely in the treatment of flatulence and for the elimination of gas or air foam from the gastrointestinal tract in man.
5.2 Pharmacokinetic properties
Simethicone is not absorbed following oral administration. Physiologically, silicones are extremely inert. It is considered to be non-toxic.
Target species
Cattle.
Indications
For the relief of gaseous and frothy bloat in cattle.
Dosage
By oral administration, 50 to 100 ml. A second dose may be given 3 hours later if required.
Contraindications
None known.
Adverse reactions
None known.
Warnings
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.
Use during pregnancy, lactation or lay
No special precautions.
Interactions
None known.
Overdose
Not known.
Special warnings
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.
Withdrawal period
Meat: Zero days
Milk: Zero hours
Incompatibilities
None known.
Immediate packaging
100 ml, low density, opaque, polyethylene bottle with a black, urea formaldehyde R6/22 mm cap, with an expanding polyethylene wad.
Storage
Shake the bottle before use.
Do not store above 25oC.
Do not freeze.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Disposal of unused product
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Additional information
Vm 36408/4016
9 DATE OF FIRST AUTHORISATION
30 March 1994
10 DATE OF REVISION OF THE TEXT
August 2021
Approved 18 August 2021
Registration holder
Alfasan Nederland B.V.
Kuipersweg 9
3449 JA Woerden
The Netherlands
Regulations
- Veterinary Medicines Regulations 2013 (SI 2013/2033), Schedule 32