Fatroseal 2.6 g Intramammary Suspension for Dry Cows

Composition

Each 4 g intramammary syringe contains:

Active substance:

Bismuth, heavy 1.858 g equivalent to Bismuth subnitrate, heavy 2.6 g

Excipients:

Qualitative composition of excipients and other constituents

Aluminium stearate

Silica, colloidal anhydrous

Paraffin, liquid

White to greyish homogeneous suspension.

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Pharmacological properties

4.1 ATCvet code: QG52X

4.2 Pharmacodynamics

Infusion of the veterinary medicinal product into each udder quarter produces a physical barrier against the entry of bacteria there by reducing the incidence of new intramammary infections during the dry period.

4.3 Pharmacokinetics

Bismuth subnitrate is not absorbed from the mammary gland, but resides as a seal in the teat until physically removed (shown in cows with a dry period up to 100 days).

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Target species

Cattle (dairy cows at drying-off).

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Indications

Prevention of new intramammary infections throughout the dry period.

In cows considered likely to be free of sub-clinical mastitis, the veterinary medicinal product can be used alone in dry cow management and mastitis control.

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Dosage

Intramammary use.

The veterinary medicinal product has a dual tip nozzle. The cap of the syringe can be partially or fully removed. It is recommended to pinch the teat at the base as it aids in positioning the paste in the teat cistern, sealing the teat canal from the top.

Short tip option: The short tip option allows for a partial insertion technique so that the syringe only needs to be inserted in the teat end.

Long tip option: The long tip option may be used for treatment convenience for example to prevent the tip from flipping out due to a moving or nervous cow.

Step 1: Removal of the breakable cap

Step 2: Short or long tip insertion

Infuse the contents of one intramammary syringe of the veterinary medicinal product into each udder quarter immediately after the last milking of the lactation at drying off. Do not massage the teat or udder after infusion of the veterinary medicinal product because it is important that the sealant stays in the teat itself and does not enter the udder.

Care must be taken not to introduce pathogens into the teat in order to reduce the risk of post-infusion mastitis.

It is essential that the teat is thoroughly cleaned and disinfected, with surgical spirit or alcohol-impregnated wipes. The teats should be wiped until the wipes are no longer visibly dirty. Teats should be allowed to dry prior to infusion. Infuse aseptically and take care to avoid contamination of the syringe nozzle. Following infusion it is advisable to use an appropriate teat dip or spray.

Under cold conditions the veterinary medicinal product may be warmed to room temperature in a warm environment, to aid syringeability.

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Contraindications

Do not use in lactating cows. See section 3.7.

Do not use the veterinary medicinal product alone in cows with sub-clinical mastitis at drying off.

Do not use in cows with clinical mastitis at drying off.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

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Adverse reactions

Cattle (dairy cow at drying-off).

Very rare (<1 animal / 10,000 animals treated, including isolated reports):

Acute mastitis1

1 Primarily due to poor infusion technique and lack of hygiene. Please refer to sections 3.5 and 3.9 regarding the importance of aseptic technique.

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:

It is good practice to observe dry cows regularly for signs of clinical mastitis. If a sealed quarter develops clinical mastitis, the affected quarter should be stripped out manually before appropriate therapy is instituted.

To reduce the risk of contamination, do not immerse the syringe in water.

Use the syringe only once.

Since the veterinary medicinal product does not have antimicrobial activity, in order to minimize the risk of acute mastitis due to poor infusion technique and lack of hygiene (see section 3.6), it is crucial to follow the aseptic technique of administration described in section 3.9.

Do not administer any other intramammary product following administration of the veterinary medicinal product. In cows that may have sub-clinical mastitis, the veterinary medicinal product may be used following administration of a suitable dry cow antibiotic treatment to the infected quarter.

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

Bismuth salts have been associated with hypersensitivity reactions.

People with known hypersensitivity (allergy) to bismuth salts should avoid contact with the veterinary medicinal product.

This veterinary medicinal product may cause skin and eye irritation.

Avoid contact with skin or eyes.

Should skin or eye contact occur, wash the affected area thoroughly with water. If irritation persists, seek medical advice and show this label to the physician.

If provided, the cleaning wipes may cause skin and eye irritation in some people due to the presence of isopropyl alcohol and chlorhexidine digluconate. Avoid contact with skin or eyes.

Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy:

The veterinary medicinal product is not absorbed following intramammary infusion. Can be used during pregnancy. At calving, the seal may be ingested by the calf. Ingestion of the veterinary medicinal product by the calf is safe and produces no adverse effects.

Lactation:

The veterinary medicinal product is contra-indicated for use during lactation. If accidentally used in a lactating cow, a small (up to 2-fold) transient rise in somatic cell count may be observed. In such an event, strip out the seal manually, no additional precautions are necessary.

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Interactions

In clinical trials, the compatibility of a comparable teat seal formulation containing bismuth subnitrate has only been shown with a cloxacillin-containing dry cow preparation. See also section 3.5 “Special precautions for safe use in the target species”.

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Overdose

Twice the recommended dose has been administered to cows with no clinical adverse effects.

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Special warnings

Selection of cows for treatment should be based on veterinary clinical judgement. Selection criteria may be based on the mastitis and cell count history of individual cows or recognised tests for the detection of subclinical mastitis or bacteriology sampling.

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Withdrawal period

Meat and offal: Zero days.

Milk: Zero hours.

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Incompatibilities

Not applicable.

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Immediate packaging

A single dose LDPE intramammary syringe closed with a LDPE cap containing 4 g of suspension, in a cardboard box.

Package sizes:

Cardboard box with 24 syringes

Cardboard box with 60 syringes

Cardboard box with 120 syringes

Cardboard box with 24 syringes and 24 cleaning wipes

Cardboard box with 60 syringes and 60 cleaning wipes

Cardboard box with 120 syringes and 120 cleaning wipes

Not all pack sizes may be marketed.

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Storage

This veterinary medicinal product does not require any special temperature storage conditions.

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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 11557/5002

8 DATE OF FIRST AUTHORISATION

30 March 2022

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

May 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: 04 July 2025

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Registration holder

Fatro S.p.A.

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