Butasal 100 mg/ml + 0.05 mg/ml Solution for Injection for Horses, Cattle, Dogs and Cats

Composition

Each ml of the solution for injection contains:

Active substances:

Butafosfan 100.0 mg

Cyanocobalamin (vitamin B12) 0.05 mg

Excipients:

Clear red solution without visible particles.

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Pharmacological properties

4.1 ATCvet code: QA12CX99

4.2 Pharmacodynamics

Butafosfan is a synthetically produced organic phosphorus compound. It is used as an exogenous source of phosphorus, which is important for energy metabolism. It is essential for gluconeogenesis since most intermediates of that process need to be phosphorylated.

Cyanocobalamin is a unique cobalt-containing vitamin which is a semi-synthetic form of vitamin B12. It functions as a co-factor for two of the enzymes important in fatty acid synthesis and in the biosynthesis of glucose from propionate.

Cyanocobalamin belongs to the family of water-soluble B-vitamins which are synthesized by the microbial flora in the digestive tract of domestic animals (forestomachs and large intestine).

When administered parenterally, cyanocobalamin is directly available as a source of vitamin B12.

4.3 Pharmacokinetics

Butafosfan is rapidly absorbed from the injection site when administered subcutaneously or intramuscularly. The maximum plasma concentration is reached approximately 30 minutes after administration. Butafosfan is distributed to the liver, kidney, muscle and skin/fat and is excreted rapidly, mainly in urine (74 % in the first 12 hours), while less than 1 % is excreted in faeces.

In studies in cattle after a single intravenous administration of a single dose of 5 mg/kg body weight elimination is relatively rapid with a terminal half-life of 3.2 hours. In cows it was established that milk excretion was low.

In studies in horses, after intravenous administration of butafosfan at a dose of 10 mg/kg of body weight, the value Cmax was reached within 1 minute, while the biological half-life is approximately 78 minutes.

In studies in dogs after a single subcutaneous administration of a single dose of 20 mg/kg body weight, absorption and butafosfan elimination is relatively rapid. Tmax in dogs is 0.75 h, while the terminal half-life is approximately 9 hours.

Cyanocobalamin is rapidly and extensively absorbed into the blood after subcutaneous or intramuscular administration to animals. In serum, it is bound to specific transport proteins called transcobalamins. It is distributed extensively into all tissues and tends to accumulate in the liver. The principal routes of excretion of absorbed vitamin B12 are via urine, bile, and faeces. Urinary excretion of unmetabolised vitamin B12 by kidney glomerular filtration is minimal and biliary excretion via faeces is the major excretory route. Much of the cobalamin excreted in bile is reabsorbed; at least 65 to 75 % is reabsorbed in the ileum by means of the “intrinsic factor” active transport mechanism.

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Target species

Horses, cattle, and dogs

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Indications

All target species:

- Supportive treatment and prevention of hypophosphatemia and/or cyanocobalamin (vitamin B12) deficiency.

Cattle:

- Supportive treatment to restore rumination following surgical treatment of displaced abomasum associated with secondary ketosis.

- Complementary treatment of parturient paresis in addition to Ca/Mg therapy.

- Prevention of ketosis development, if administered before calving.

Horses:

- Adjunctive therapy in horses suffering from muscular exhaustion.

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Dosage

Cattle, horses: for intravenous (i.v.) use.

Dogs: for intravenous (i.v.), intramuscular (i.m.), subcutaneous (s.c.) use.

It is recommended that the solution is warmed to body temperature before administration.

The dose depends on the animal’s body weight (bw) and condition.

For the supportive treatment of secondary ketosis in cows, the recommended dose should be administered on three consecutive days.

For the prevention of ketosis in cows, the recommended dose should be administered on three consecutive days within the period of 10 days before expected calving.

For other indications, treatment should be repeated as necessary.

The cap may be safely punctured up to 15 times.

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Contraindications

Do not use in cases of hypersensitivity to the active substance(s) or to any of the excipient(s).

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Adverse reactions

Horses, cattle and dogs:

1 Has been reported following subcutaneous administration in dogs.

2 In cases where rapid intravenous infusion has occurred.

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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Intravenous administration should be done very slowly since cases of circulatory shock may be associated with too rapid injection.

In dogs suffering from chronic renal insufficiency the veterinary medicinal product should only be used according to the benefit-risk assessment by the responsible veterinarian.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

Benzyl alcohol may cause hypersensitivity (allergic reactions). People with known hypersensitivity to benzyl alcohol or any of the excipients should avoid contact with the veterinary medicinal product.

This veterinary medicinal product may cause skin and eye irritation. Avoid contact with skin and eyes. In case of accidental exposure, rinse the affected area thoroughly with water.

Self-injection should be avoided. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Wash hands after use.

Special precautions for the protection of the environment:

Not applicable

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable

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Use during pregnancy, lactation or lay

Can be used during pregnancy and lactation in cows.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation in mares and bitches. Laboratory studies in rats have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.

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Interactions

None known.

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Overdose

No adverse effect was reported after intravenous administrations up to 5 times the recommended dose in cattle.

Except transient slight swelling at the injection site, no other adverse effect was reported after subcutaneous administrations up to 5 times the recommended dose in dogs.

No overdose data are available for dogs after intravenous and intramuscular administrations.

No overdose data are available for horses.

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Special warnings

It is recommended to determine the cause(s) of the metabolic or reproductive disorders to define the most appropriate measures of prevention and treatment and the need for a therapy with supplemental phosphorus and vitamin B12.

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Withdrawal period

Cattle, horses:

Meat and offal: zero days

Milk: zero hours

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Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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Immediate packaging

Amber glass vial, closed with a bromobutyl rubber stopper and secured with an aluminium cap or flip-off cap with polypropylene cover.

Package size:

Cardboard boxes of 1 vial of 50 mL or 100 mL

Cardboard box of 6 carton boxes of 1 vial of 50 mL or 100 mL

Not all pack sizes may be marketed.

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Storage

Do not store above 25 °C.

Keep the vial in the outer carton in order to protect from light.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years

Shelf life after first opening the immediate packaging: 28 days

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Disposal of unused product

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.

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Additional information

Vm 51467/4002

8 DATE OF FIRST AUTHORISATION

06 May 2021

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

February 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Gavin Hall Approved: 19 May 2025

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Registration holder

Interchemie Werken De Adelaar Eesti AS

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