Spasmipur 20mg/ml Solution for Injection 50ml

Spasmipur hyoscine butylbromide injection for horses, cattle, sheep and pigs

Hyoscine butylbromide is an antispasmodic agent which relaxes smooth muscle of the organs of the abdominal and pelvic cavities. It antagonises the actions of acetylcholine at muscarinic receptors.

Spasmipur is used to treat acute spasms of the gastrointestinal tract (colic) and of the urinary tract, and as an aid in procedures for which reduced peristaltic activity of the gut or reduced contractions in the urinary tract are required. The treatment is essentially symptomatic, so the underlying disorder also needs appropriate handling by your vet.

Key features of Spasmipur 20mg/ml Solution for Injection:

• Active ingredient: hyoscine butylbromide 20mg per ml (equivalent to 13.8mg hyoscine).
• Licensed for horses, cattle, sheep and pigs.
• Intravenous or intramuscular injection: intramuscular only where intravenous injection is not possible.
• 50ml multi-dose vial: the stopper can be punctured a maximum of 25 times; use within 28 days of first opening.
• Single active ingredient: for a combination with the analgesic metamizole, Spasmium Comp is the related product.

For use under veterinary direction

Spasmipur is a prescription-only veterinary medicine and is dosed by bodyweight for each species. Horses should be monitored carefully following treatment. See our range of vet medicines and equine care products.

Always follow the directions and dosage given to you by your prescriber.

Dosage

For intravenous or intramuscular use.

Horses, cattle and pigs: 0.2 - 0.4 mg of hyoscine butylbromide/kg body weight by intravenous injection (equivalent to 0.1 - 0.2 ml of the veterinary medicinal product/10 kg body weight).

Sheep: 0.7 mg of hyoscine butylbromide/kg body weight by intravenous injection (equivalent to 0.35 ml of the veterinary medicinal product/10 kg body weight).

Do not use in horses less than 6 weeks of age.

To reduce contractions of the smooth muscle in the gastrointestinal or urinary tract (spasmolytic effect)

If necessary, treatment can be repeated once at 12 hours after initial administration according to the veterinarian criteria.

Only in cases where intravenous injection is not possible, the veterinary medicinal product may be administered intramuscularly at the higher dose specified for the respective target species.

For clinical procedures

Administer immediately before inactivity in the gastrointestinal or urinary tract is required. For clinical procedures use intravenous administration only.

Administration

A slow injection when using either the intravenous or the intramuscular route is recommended.

To ensure a correct dosage, body weight should be determined as accurately as possible and dosing devices or syringes with suitable graduations are to be used.

The rubber stopper can be punctured a maximum of 25 times.

Before use

Do not use:

• in case of paralytic ileus, mechanical obstruction, or cardiac disorders.
• in cases of hypersensitivity to the active substance or to any of the excipients.
• in horses with glaucoma.
• in horses less than 6 weeks of age.

Special precautions for use in animals: Horses should be monitored carefully following treatment. The treatment is essentially symptomatic and an appropriate handling of the underlying disorder is necessary.

Precautions for the person giving the injection:

• People with known hypersensitivity to hyoscine butylbromide or benzyl alcohol should avoid contact with the veterinary medicinal product.
• Accidental self-injection may result in cardiac and circulatory effects. Avoid accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
• The veterinary medicinal product can cause skin and eye irritation. Avoid contact with skin and eyes. In the case of contact with skin, wash with soap and water. If irritation persists, seek medical advice. Wash hands after use.
• If the veterinary medicinal product comes into contact with the eyes, rinse the eyes immediately with plenty of water and seek medical attention if irritation persists.

Pregnancy and lactation: Laboratory studies in mice have not produced any evidence of teratogenic effects. No information on use during pregnancy in the target species is available. An effect upon the smooth muscles of the birth canal can occur. Hyoscine butylbromide, like all other anticholinergic agents, can inhibit the production of milk. Due to its low solubility in fat, excretion of hyoscine butylbromide in milk is very low. Use only according to the benefit-risk assessment by the responsible veterinarian.

Interactions: This veterinary medicinal product may enhance the tachycardic effects of beta-adrenergic drugs and may alter the effect of other drugs, such as digoxin. The effects of hyoscine butylbromide may be potentiated by the concomitant use of other anticholinergic drugs. Co-administration with other anticholinergic or parasympatholytic drugs should be avoided.

Withdrawal periods: Meat and offal: horses 3 days, cattle 2 days, sheep 18 days, pigs 9 days. Milk: horses, cattle and sheep 12 hours.

Adverse events and overdose

Horses: Very rare (less than 1 animal in 10,000 animals treated, including isolated reports): tachycardia. Undetermined frequency (cannot be estimated from the available data): colic, due to inhibition of motility.

Cattle, sheep, pigs: Very rare (less than 1 animal in 10,000 animals treated, including isolated reports): tachycardia.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system.

Overdose: In case of overdose, anticholinergic symptoms, such as urinary retention, thirst, tachycardia, inhibition of gastrointestinal motility and transient visual disturbances may occur. If necessary, parasympathomimetic drugs can be administered. In addition, appropriate supportive measures should be used as required.

Storage and disposal

• This veterinary medicinal product does not require any special storage conditions. After first opening the immediate packaging, do not store above 25°C.
• Shelf life after first opening the immediate packaging: 28 days.
• Medicines should not be disposed of via wastewater or household waste. Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

Active ingredient: Hyoscine butylbromide 20 mg per ml (equivalent to 13.8 mg hyoscine).

Other ingredients: Benzyl alcohol (E1519) 20 mg per ml, Water for injection.

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We cannot guarantee the Patient Information Leaflet is accurate and is for reference only.