SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

ORBESEAL Dry cow intramammary suspension

Finland only – ORBESEAL (2.6g bismuth subnitrate, heavy; intramammary

suspension)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 4g syringe contains:

Active substance: Bismuth subnitrate, heavy 2.6g

Excipient(s): qs 4g

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Intramammary suspension (Greyish white, smooth, unctuous cream).

4. CLINICAL PARTICULARS

4.1 Target species

Cattle (dairy cows).

4.2 Indications for use, specifying the target species

Prevention of new intramammary infections throughout the dry period.

In cows considered likely to be free of sub-clinical mastitis, Orbeseal can be used on its own in dry cow management and mastitis control.

Selection of cows for treatment with Orbeseal 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

See section 4.7. Do not use the product alone in cows with sub-clinical mastitis at drying off. Do not use in cows with clinical mastitis at drying off.

4.4 Special warnings

None.

4.5 Special precautions for use

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 Orbeseal, because the product does not have antimicrobial activity.

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

In cows that may have sub-clinical mastitis, Orbeseal 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

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 absorbed following intramammary infusion, Orbeseal can be used in pregnant animals. At calving, the seal may be ingested by the calf. Ingestion of Orbeseal by the calf is safe and produces no adverse effects.

Lactation:

Orbeseal 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.

4.8 Interaction with other medicinal products and other forms of interaction

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

4.9 Amounts to be administered and administration route

For intramammary infusion only.
Infuse the contents of one syringe of Orbeseal 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.

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.

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

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

4.11 Withdrawal period(s)

Meat: Zero days.
Milk: Zero days.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Various products for teats and udder

ATCvet code: QG52X

5.1 Pharmacodynamic properties

Infusion of Orbeseal into each udder quarter produces a physical barrier against the entry of bacteria thereby reducing the incidence of new intramammary infections during the dry period.

5.2 Pharmacokinetic particulars

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).

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Liquid paraffin

Aluminium Di Tri Stearate

Silica, Colloidal Anhydrous

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 5 years

6.4. Special precautions for storage

No special precautions for storage.

6.5 Nature and composition of immediate packaging

A single dose intramammary syringe containing 4 g of a greyish white intramammary paste.
Primary packaging: Low-density polyethylene syringe with a smooth, tapered hermetically sealed nozzle.

Marketing presentations: boxes of 24, 60 and 120 syringes.

Not all pack sizes may be marketed

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused product, seal stripped from an animal at calving or waste materials should be disposed of in accordance with national requirements.

7. MARKETING AUTHORISATION HOLDER

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

8. MARKETING AUTHORISATION NUMBER

Vm 42058/4092

9. DATE OF FIRST AUTHORISATION

25 June 2002

10. DATE OF REVISION OF THE TEXT

March 2014

Approved: 20/03/2014