Noroseal 2.6 g Intramammary Suspension for Cattle

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Bismuth subnitrate, heavy
Available from:
Norbrook Laboratories Limited
ATC code:
QG52X
INN (International Name):
Bismuth subnitrate, heavy
Dosage:
2.6 g/syringe
Pharmaceutical form:
Intramammary suspension
Prescription type:
LM: Licensed Merchant as defined in relevant national legislation
Therapeutic group:
Cattle
Therapeutic area:
VARIOUS PRODUCTS FOR TEATS AND UDDER
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization number:
VPA10999/158/001
Authorization date:
2013-07-26

Read the complete document

Health Products Regulatory Authority

03 August 2018

CRN000X1F

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Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Noroseal 2.6 g Intramammary Suspension for Cattle

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 4g Intramammary syringe contains:

Active substance:

Bismuth subnitrate, heavy

​2.6g

For the 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 new 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 such as bacteriological sampling.

4.3 Contraindications

See section 4.7. Do not use in lactating cows. 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.

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

excipients.

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4.4 Special warnings for each target species

None.

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.

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03 August 2018

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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 interactions

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 massage the

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 period(s)

Meat & offal: zero days

Milk: zero hours

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5 PHARMACOLOGICAL or IMMUNOLOGICAL 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

6.1 List of excipients

Aluminium Stearate

Povidone, iodinated

Liquid Paraffin

6.2 Major incompatibilities

None known.

6.3 Shelf-life

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

6.4 Special precautions for storage

No special precautions for storage.

6.5 Nature and composition of immediate packaging

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.

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6.6 Special precautions for the disposal of unused veterinary medicinal

products or waste materials derived from the use of such products

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

Camlough Road

Newry

Co. Down

BT35 6JP

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

VPA10999/158/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 26

July 2013

Date of latest renewal: 25

July 2018

10 DATE OF REVISION OF THE TEXT

August 2018

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