SUMMARY OF PRODUCT CHARCTERISTICS

1. Name of the veterinary medicinal product

Amoxycare Suspension for Injection 15% w/v

2. Qualitative and quantitative composition

Each ml contains

Active Substance(s) mg

Amoxicillin 150.0

(as Amoxicillin Trihydrate 172.1

Excipients

Butylated Hydroxytoluene 0.08 (as antioxidant)

Butylated Hydroxyanisole 0.08 (as antioxidant)

For a full list of excipients, see section 6.1

3. Pharmaceutical form

Suspension for injection.

An off-white suspension.

4. Clinical Particulars

4.1 Target species

Cattle

Sheep

Pigs

Dogs

Cats

4.2 Indications for use, specifying the target species

For the treatment of infections caused by a wide range of Gram-positive and Gram-negative pathogenic bacteria including:

Actinobacillus equuli Actinomyces bovis

Actinobacillus lignieresi Bacillus anthracis

Erysipelothrix rhusiopathiae Bordetella bronchiseptica

Escherichia coli Clostridium species

Haemophilus species Corynebacterium species

Pasteurellaspecies Fusiformis species

Proteus mirabilis Moraxellaspecies

Salmonella species

Staphylococci

Streptococci

Not effective against beta-lactamase producing organisms.

4.3 Contraindications

Intravenous or intrathecal use.

Use in rabbits, hamsters, gerbils and guinea pigs.

Use in known cases of hypersensitivity to Amoxicillin.

4.4 Special Warnings for each target species

None known.

i Special precautions for use in animals

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. In the case of accidental self-injection, seek medical advice immediately. 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.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

Occasional local tissue reaction may result from use of this product.

4.7 Use during pregnancy, lactation or lay

Can be safely administered during pregnancy and lactation

4.8 Interaction with other medicinal products and other forms of interaction

It is not generally recommended to use bactericidal and bacteriostatic antibiotics at the same time.

4.9 Amounts to be administered and administration route

Cattle, sheep and pigs : By intramuscular injection only

Dogs and cats : By subcutaneous or intramuscular injection.

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

The recommended dosage rate is 7 mg/kg bodyweight once a day for up to five days. Massage the injection site. A separate injection site should be used for each administration.

Animal	Weight (kg)	Dose volume (ml)
Cattle	450	20.0
Sheep	65	3.0
Pigs	150	7.0
Dogs	20	1.0
Cats	5	0.25

(Guide-dose volume is equivalent to about 0.25 ml per 5 kg daily).

Maximum dose volumes at one injection site are 20 ml cattle, 10 ml sheep and pigs. An appropriate graduated syringe must be used when administering small volumes to ensure accurate dosing. Normal aseptic precautions should be observed.

Shake vial before use. This product does not contain an antimicrobial preservative. Swab the septum before removing each dose. Use a dry, sterile needle and syringe.

Penicillins have a remarkably good safety record and overdose is highly unlikely.

Milk for human consumption must not be taken from a cow during treatment. Milk for human consumption may only be taken after 24 hours from the last treatment.

Not for use in sheep producing milk for human consumption.

Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 18 days from the last treatment. Sheep may be slaughtered for human consumption only after 10 days from the last treatment. Pigs may be slaughtered for human consumption only after 16 days from the last treatment.

5. pharmacological properties

Pharmacotherapeutic group: Antibiotic

ATC Vet Code: QJ01CA04

Amoxicillin predominately inhibits cell wall synthesis in susceptible bacteria. Amoxicillin has a unique mode of action which directly and irreversibly disrupts existing cell wall peptidoglycan rather than newly forming peptidoglycan of the divisory septal wall as with other members of the penicillin family. Amoxicillin is well absorbed after parenteral administration.

6. Pharmaceutical particulars

6.1 List of excipients

Butylated Hydroxyanisole

Butylated Hydroxytoluene

Aluminium Stearate

Propylene Glycol Dicaprylocaprate

None.

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

Do not store above 25ºC.

Amoxycare Suspension for Injection 15% w/v is supplied in:

- 50 ml and 100 ml clear glass type II vials closed with nitrile rubber bungs and aluminium overseals.

- 50 ml and 100 ml clear polyethylene terephthalate (PET) plastic vials closed with nitrile rubber bungs and aluminium overseals.

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

Camlough Road

Newry

Co. Down

BT35 6JP

Northern Ireland

8. MARKETING AUTHORISATION NUMBER

Vm 02000/4140

9. DATE OF FIRST AUTHORISATION

Date: 9 January 1998

10. DATE OF REVISION OF THE TEXT

Date: October 2014

APPROVED 23/10/14