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Buscopan is given to relieve abdominal discomfort and cramps. It acts to reduce gut muscle spasm and discomfort. Injections and tablets are available.
Colourless solution for injection. Each ml contains 20 mg hyoscine butylbromide plus 1.8 mg methyl parahydroxybenzoate and 0.2 mg propyl parahydroxybenzoate as excipients.
Horse: The product is indicated for antispasmodic treatment in case of equine colic.
Calf: The product is indicated for antispasmodic effect, as an aid to the symptomatic treatment of calf scour. Oral re-hydration and other appropriate therapy must also be administered as required.
Horse: The product should be administered at a dosage of 0.3 mg hyoscine butylbromide per kg body weight, by a single intravenous injection. This corresponds to 1.5 ml of the product/100 kg body weight i.v.
Calf:The product should be administered at a dosage of 0.4 mg hyoscine butylbromide per kg body weight, by a single intramuscular injection. This corresponds to 2 ml of the product/100 kg body weight i.m.
Do not use in horses suffering from paralytic ileus.
Do not use in horses less than 6 weeks of age.
Do not use in case of hypersensitivity to the active substance or any of the excipients.
In case of no clinical response the necessity for surgical intervention should be taken into consideration.
Horses should be monitored carefully following treatment. If the response to treatment with the product is poor, careful re-evaluation of the diagnosis should be made and the possibility of surgical intervention should be considered, as the product does not mask symptoms of surgical cases.
In cases of mechanical obstruction of the gut, concomitant therapy with polyionic fluids, laxatives and analgetics should be considered.
In animals with cardiac dysfunction the product should be administered after making a risk/benefit assessment.
People with known hypersensitivity to hyoscine butylbromide or methyl-, or propyl parahydroxybenzoate should avoid contact with the product. Wear impermeable gloves. In the case of accidental spillage onto the skin or eyes, wash off splashes from skin and eyes with clean running water.
A slight transient increase in heart rate may be observed due to the parasympatholytic activity of hyoscine butylbromide.
The use is not recommended during pregnancy.
The effects of hyoscine butylbromide may be potentiated by the concomitant use of other anticholinergic drugs. Do not use in combination with other drugs that act on the (para) sympathic system. Concomitant therapy should take in consideration the pharmacokinetic properties of hyoscine butylbromide. Concurrent use of Non-Steroidal-Anti-Inflammatory Drugs (NSAIDS), or other products with analgesic properties may mask signs of clinical conditions requiring further diagnosis and treatment.
In a tolerance study in horses, using up to 5 times the recommended dosage of 0.3 mg/kg, the product is well tolerated.
A five-fold overdose occasionally produced signs of a transient, slight decrease in defecation frequency. A ten-fold over dosage in horses produced a transitory absence of pupillary light reflex, a transitory increase of heart rate and lower intestinal motility. Signs of colic due to enteroparalysis appear 6 - 8 hours after administration. Adverse effects after over dosage should disappear without any further treatment within 6 hours.
Intramuscular injection of the product at up to three-fold of the recommended dose was systemically and locally well tolerated in calves. In case of overdose parasympatholytic symptomatology may be present.
Horse: Meat and offal: 1 day
Calf: Meat and offal: 2 days
Not permitted for use in lactating animals producing milk for human consumption.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Shelf life after first opening the immediate packaging: 28 days
This veterinary medicinal product does not require any special storage conditions.
Any unused product or waste materials should be disposed of in accordance with local requirements.
For animal treatment only.
Keep out of reach and sight of children.
Colourless injection glass vials (Type I) with siliconized and Teflon-faced stoppers made of bromobutyl rubber and crimp-on aluminium caps. Each vial contains 50 ml and is packed into a collapsible carton.
Like other belladonna alkaloid derivatives, this compound antagonises the actions of acetylcholine at the muscarinic receptor and also possesses slight additional activity at nicotinic receptors. Its pharmacological profile is qualitatively similar to the principal member of this class, atropine. In contrast to atropine hyoscine butylbromide does not cross the blood-brain barrier and exhibits less impact on the cardiovascular system as well as less inhibition of salivary and lacrimal secretion. In comparison to atropine the duration of effect is shorter and disappears without any antidote. The antispasmodic effect of hyoscine butylbromide results in relaxation of smooth musculature lasting for approximately 20 - 45 minutes. A dose dependent increase in heart rate as well as inhibition of salivation and lacrimation can be observed.
The quaternary ammonium structure of the active substance prevents penetration into the central nervous system after parenteral administration. The elimination half-life from plasma in the target species is 1 - 2 hours. Hyoscine butylbromide is very rapidly eliminated from the blood. Two hours after the intravenous administration of the product, serum levels of hyoscine butylbromide fall below the lower limit of detection of 100 ng/ml. After parenteral administration in horses, hyoscine butylbromide is eliminated mainly via urine, mainly as unchanged substance.
Buscopan 20 mg/ml solution for injection for horses and calves
A slightly yellow solution for injection. Each ml contains 4 mg butylscopolamine bromide and 500 mg metamizole as active ingredients plus 5 mg phenol as preservative.
As an aid in the control of pain associated with simple equine colic and as a diagnostic aid in more severe equine colics.
For the control of diarrhoea in cattle, horses and dogs particularly when pain or abdominal discomfort is present.
For the control of pain associated with urinary obstruction in horses and dogs.
Use aseptic techniques
5 ml per 100 kg bodyweight by intravenous injection only
5 ml per 100 kg bodyweight by intravenous or intramuscular injection
0.1 ml per kg bodyweight by intravenous or intramuscular injection
Due to a risk of local reactions, do not use the intramuscular route in horses.
Do not use in pregnant animals as safety during pregnancy in the target species has not been established.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in horses suffering from paralytic ileus.
In horses, a slight transient increase in heart rate may be observed due to the parasympatholytic activity of butylscopolamine bromide.
Take care to avoid self-injection. In a very small number of people, metamizole can cause reversible, but potentially serious agranulocytosis and other reactions such as skin allergy. Avoid use of the product if you are known to be sensitive to pyrazolones, or are sensitive to aspirin. Wash any splashes from the skin. If accidental self-injection occurs, seek medical advice and show the Doctor the product packaging.
Studies in laboratory animals (rabbit, rat) have not produced any evidence of a teratogenic effect. No information on use during pregnancy in the target species is available and therefore this product should not be used.
The effects of metamizole and/or butylscopolamine bromide may be potentiated by concurrent use of other anticholinergic or analgesic drugs.
The acute toxicity of both compounds is very low. In studies with rats, the symptoms were non-specific and included ataxia, mydriasis, tachycardia, prostration, convulsions, coma and respiratory signs.
Symptomatic treatment should be initiated in case of overdosage.
Animals should not be slaughtered for human consumption during treatment.
Meat and offal:
Horses - 12 days
Cattle - 9 days after intravenous injection, 28 days after intramuscular injection.
Do not use in cows producing milk for human consumption.
Do not store above 25°C. Protect from light. Avoid introduction of contamination during use. Should any apparent growth or discolouration occur, discard the product.
Shelf life of the unopened vial: 4 years
Following withdrawal of the first dose use the product within 28 days after which discard unused material.
Keep out of the reach and sight of children.
For animal treatment only.
To be supplied only on veterinary prescription. To be used in accordance with the directions of a veterinary surgeon.
Any unused product or waste material should be disposed of in accordance with national requirements.
Multidose amber 100ml Type II glass injection bottles with grey bromobutyl rubber stoppers and aluminium overseals.
Butylscopolamine bromide is a spasmolytic agent with particular activity on the smooth muscle of the digestive and urinary systems. It antagonises the actions of acetylcholine at the muscarinic receptor and also has some activity at nicotinic receptors. Its pharmacological profile is similar to atropine, the main member of this class.
The quarternary ammonium structure confers poor absorption after oral administration and prevents penetration of the central nervous system after parenteral administration. 17-24% is plasma protein bound and plasma elimination half-life is 2-3 hours. It is excreted mostly unchanged - about 54% via the kidneys in urine after parenteral administration. After oral administration, only around 1% is excreted in urine.
Metamizole is a non-steroidal anti-inflammatory drug of the pyrazolone group and also has analgesic and anti-pyretic effects. It is rapidly absorbed with absolute bioavailability of nearly 100%. The primary metabolite in plasma and urine is 4-methyl-aminoantipyrine (MAA), which is pharmacologically active with a plasma half life of around 6 hours. Other metabolites are present in smaller quantities. The metabolites are bound (to various degrees) to plasma proteins, with 56% MAA bound. Excretion occurs mainly via the kidney, with 50-70% of the dose eliminated in urine, depending on species.
Buscopan Compositum Solution for Injection
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