Bimacure 500mg Intrauterine Suspension for Cattle

Composition

Each syringe contains:

Active substance:

Cefapirin 500 mg

(as Cefapirin benzathine)

Excipients:

Qualitative composition of excipients and other constituents

Macrogol cetostearyl ether-20

Macrogol cetostearyl ether-12

Hydrogenated castor oil

Triglycerides, medium chain

A creamy, oily suspension.

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Pharmacological properties

4.1 ATCvet code:

QG51AA05.

4.2 Pharmacodynamics

Cefapirin, a first-generation cephalosporin, is a broad-spectrum antibiotic with bactericidal action against gram-positive and gram-negative bacteria. Cefapirin is resistant to the action of penicillinase.

4.3 Pharmacokinetics

After intrauterine treatment systemic absorption is low, which is reflected by the low plasma levels of cefapirin observed shortly after treatment. High cefapirin concentrations are observed in endometrium.

Twelve hours after treatment, cefapirin levels in plasma are below detectable levels. Cefapirin concentrations in endometrium can be observed up to 24 hours.

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Target species

Cows.

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Indications

For the treatment of subacute and chronic endometritis in cows (at least 14 days after parturition) caused by bacteria susceptible to cefapirin.

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Dosage

For intrauterine use.

The contents of one syringe of the veterinary medicinal product, corresponding to 500 mg of cefapirin (as cefapirin benzathine) should be introduced into the lumen of the uterus using the disposable catheter provided as follows:

1. The product may settle but can be re-suspended by gentle shaking into a homogeneous suspension.

2. Fix the syringe to the catheter.

3. Take the cervix of the uterus into one gloved hand introduced into the rectum.

4. Introduce the catheter through the cervix into the lumen of the uterus, by gentle oscillating movements of the cervix.

5. Inject the contents of the syringe into the uterus.

Depending on the response, a second treatment 7-14 days later may be required in some cases if clinical signs persist.

In animals that have been inseminated, the veterinary medicinal product may be used one day after insemination. In cases of pyometra, pre-treatment with prostaglandin is recommended in order to induce luteolysis and remove debris from the uterine cavity.

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Contraindications

Do not use in in animals with known hypersensitivity to cephalosporins or to any of the excipients.

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Adverse reactions

Cattle (cows):

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. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Use of the veterinary medicinal product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to cefapirin and may decrease the effectiveness of the treatment.

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

Penicillin and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead to cross reactions to cephalosporins and vice versa.

Allergic reactions to these substances are occasionally serious.

1. Do not handle this veterinary medicinal product if you know you are sensitised or if you have been advised not to work with such preparations.

2. Handle this veterinary medicinal product with great care to avoid exposure, taking all recommended precautions.

3. If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.

Personal protective equipment consisting of protective gloves should be worn when handling the veterinary medicinal product.

Accidental spillage on the skin should be washed off immediately with soap and water.

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

Pregnancy and lactation:

The use is not recommended during pregnancy.

Can be used during lactation.

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Interactions

Not to be administered concurrently with other intrauterine antibiotic preparations.

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Overdose

The veterinary medicinal product is supplied as a single dose syringe therefore overdose is unlikely to occur.

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Special warnings

None.

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Withdrawal period

Meat and offal: 1 day.

Milk: Zero hours.

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Incompatibilities

None known.

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Immediate packaging

Low linear density polyethylene syringe barrel with low density polyethylene plunger and cap containing 19g of oily suspension, packed in boxes of 10 syringes. Intrauterine catheters are provided for administration.

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Storage

This veterinary medicinal product does not require any special storage conditions

Syringes are for single use only.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

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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 50146/4045

8 DATE OF FIRST AUTHORISATION

15 June 2022

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

May 2026

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 2026

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Registration holder

Bimeda Animal Health Limited

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