SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Noroseal 2.6g Intramammary Suspension for Cattle (AT, CZ, CY, DK, FI, DE, EL, HU, IE, MT, PL, RO, SK, SE, UK)

Intraseal 2.6g Intramammary Suspension for Cattle (BE, BG, EE, ES, IT, LT, LU, LV, NL, NO, PT, SI)

Noroseal Intramammary Suspension for Cattle (FR)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 4g Intramammary syringe contains:

Active substance:

Bismuth subnitrate, heavy 2.6g

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Intramammary suspension

Light brown suspension.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle (dairy cows)

4.2 Indications for use, specifying the target species

Prevention of ascending intramammary infections throughout the dry period.

In cows considered likely to be free of sub-clinical mastitis, the product may be suitable for use on its own in dry cow management for mastitis control.

Selection of cows for treatment with the product 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 sub-clinical mastitis or bacteriological sampling.

4.3 Contraindications

Do not use the product alone in cows with clinical or sub-clinical mastitis at drying off period. See section 4.5

Do not use during lactation.

4.4 Special warnings

In clinical field trials, use of the product was combined with a long-acting intramammary antimicrobial at drying-off.

4.5 Special precautions for use

(i) Special precautions for use in animals

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.

It is important to observe strict aseptic technique for the administration of the product, because the product does not have antimicrobial activity.

Do not administer any other intramammary product following administration of the product.

In cows that may have sub-clinical mastitis, the product may be used following administration of a suitable dry cow antibiotic treatment to the infected quarter.

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

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 doctor.

If you know that you are allergic to bismuth salts, avoid using this product.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

None known

4.7 Use during pregnancy, lactation or lay

Pregnancy:

As the product is not systemically absorbed following intramammary infusion, the product can be used in pregnant animals. At calving, the seal may be ingested by the calf. Ingestion of the product by the calf is safe and produces no adverse effects.

Lactation:

If accidentally used in a lactating cow, a transient rise in somatic cell count (up to 2-fold) may be observed. In such an event, strip out the seal manually, no additional precautions are necessary.

4.8 Interaction with other medicinal products and other forms of interaction

In clinical trials, the compatibility of the product has only been shown with a cloxacillin-containing dry cow preparation.

4.9 Amounts to be administered and administration route

Intramammary use.

Infuse the content of one syringe of the product into each udder quarter immediately after the last milking of the lactation (at drying off). Do not massagethe teat or udder after infusion of the product.

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

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 avoid contamination of the syringe nozzle. Following infusion it is advisable to use an appropriate teat dip or spray.

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

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Twice the recommended dose has been administered to cows without any clinical adverse effects.

4.11 Withdrawal periods

Meat & offal: zero days

Milk: zero hours

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Various products for teats and udder

ATCvet code: QG52X

5.1 Pharmacodynamic properties

Infusion of the product into each udder quarter produces a physical barrier against the penetration of bacteria thereby reducing the incidence of ascending intramammary infections during the dry period.

5.2 Pharmacokinetic particulars

Bismuth subnitrate, heavy is not systemically 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).

6. PHARMACEUTICAL PARTICULARS

Aluminium Stearate

Povidone, iodinated

Liquid Paraffin

None known

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

6.4. Special precautions for storage

No special precautions for storage.

Low density polyethylene syringe with a smooth tapered hermetically sealed nozzle.

Pack sizes:

Cartons of 24 and 60 syringes or buckets of 120 syringes including 24, 60 or 120 individually wrapped teat cleaning towels.

Not all pack sizes may be marketed.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements

7. MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Newry

Co. Down

BT35 6JP

Northern Ireland

8. MARKETING AUTHORISATION NUMBER

Vm: 02000/4361

9. DATE OF FIRST AUTHORISATION

Date:05 August 2013

10. DATE OF REVISION OF THE TEXT

Date: April 2015

Approved: 15 May 2015