SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the veterinary medicinal product

Norocillin 30% w/v Suspension for Injection

2. Qualitative and quantitative composition

Active Substance:

Procaine Penicillin 300 mg/ml (30.0% w/v)

Excipients:

Methyl Parahydroxybenzoate 0.112% w/v

Ethyl Parahydroxybenzoate 0.023% w/v

Propyl Parahydroxybenzoate 0.016% w/v

For a full list of excipients, see section 6.1

3. Pharmaceutical form

Suspension for Injection

A white to off-white suspension.

4. Clinical Particulars

4.1 Target species

Cattle

Sheep

Pigs

4.2 Indications for use, specifying the target species

For the treatment of systemic infections caused by or associated with organisms sensitive to penicillin.

In vitro tests have shown the following organisms to be sensitive: Arcanobacterium (Actinomyces) pyogenes, Erysipelothrix rhusiopathiae, Listeria, Mannheima haemolytica, Pasteurella multocida, Staphylococcus spp (non-penicillinase producing) and Streptococcus spp.

Norocillin is recommended, therefore, in the treatment of diseases caused by susceptible organisms including:

erysipelas; navel/joint-ill; respiratory tract infections including pneumonia and atrophic rhinitis; listeriosis; septicaemia; urogenital tract infections and the control of secondary bacterial invaders in diseases of primary viral origin.

4.3 Contraindications

Do not inject intravenously or intrathecally.

Do not use in known cases of hypersensitivity to penicillin.

Not to be used on very small herbivores such as guinea pigs, gerbils and hamsters.

4.4 Special Warnings for each target species

None.

4.5 Special precautions for use

(i) Special precautions for use in animals

Shake the container before use.

Care should be taken not to overdose.

Use of the 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 epidemiological information.

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

Care should be taken to avoid accidental self-injection.

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.

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

2. Handle this 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.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

Occasionally in sucking and fattening pigs, administration may cause a transient pyrexia, vomiting, shivering, listlessness and in-coordination.

4.7 Use during pregnancy, lactation or lay

Norocillin can be safely administered to pregnant and lactating animals. However in pregnant sows and gilts a vulval discharge which could be associated with abortion has been reported.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

Administer by deep intramuscular injection only.

The recommended dose rate is: 10 mg/kg bodyweight (1ml/30 kg) daily for 3 to 5 days.

To ensure the correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.

Penicillins show a wide margin of safety.

Cattle: Meat – 7 Days.

Milk – 84 Hours.

Pigs: Meat – 7 Days.

Sheep: Meat – 7 Days.

Do not use in sheep producing milk for human consumption.

5. pharmacological properties

Pharmacotherapeutic group: Antibacterials for systemic use.

ATC Vet Code: QJ01CE09

5.1 Pharmacodynamic properties

Antimicrobial activity is achieved by interference in the final stage of bacterial cell wall synthesis by binding to the PBP's (penicillin binding proteins).

6. Pharmaceutical particulars

6.1 List of excipients

Methyl Parahydroxybenzoate

Ethyl Parahydroxybenzoate

Propyl Parahydroxybenzoate

Povidone K12

Disodium Edetate Dihydrate

Potassium Dihydrogen Phosphate

Sodium Citrate Dihydrate

Polysorbate 80

Simeticone

Water for Injections

6.2 Incompatibilities

None known.

Shelf life of the veterinary medicinal product as packaged for sale: 2 Years

Shelf life after first opening the immediate packaging: 28 Days

Following withdrawal of the first dose, use the product within 28 days.

Discard unused material.

Glass vials: Do not store above 25ºC.

Plastic vials: Store in a refrigerator (2ºC – 8ºC).

Protect from light.

50 ml and 100 ml multidose type II clear glass vials closed with bromobutyl rubber bungs and aluminium caps.

50 ml, 100 ml, 250 ml and 500 ml multidose clear polyethylene terephthalate (PET) vials closed with bromobutyl rubber bungs and aluminium caps.

Not all pack sizes may be marketed.

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

7. MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Newry

BT35 6JP

8. MARKETING AUTHORISATION NUMBER

Vm 02000/4099

Date: 20^th April 1998

10. DATE OF REVISION OF THE TEXT

Date: December 2013

Approved: 20/12/2013