SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the veterinary medicinal product

Amoxycare LA 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

In vitroamoxicillin is effective against a wide range of Gram-positive and Gram-negative bacteria which include:

Escherichia coli

Klebsiella pneumoniae

Proteus species

Salmonella species

Staphylococci and

Streptococci

Not effective against beta-lactamase producing organisms.

Amoxycare LA Injection is suitable for the control of infections due to susceptible micro-organisms in cattle, sheep, pigs, dogs and cats where a single injection giving prolonged activity is required. It may also protect from secondary bacterial invasion due to sensitive organisms in cases where bacteria are not the initial cause of the disease.

Indications include infections of:

(a) Alimentary tract

(b) Respiratory tract

(c) Skin and soft tissue

(d) Urogenital tract and,

(e) In prevention of post-operative infection (treat before surgery).

4.3 Contraindications

This product is not suitable for intravenous or intrathecal use.

This product should not be administered to rabbits, hamsters, gerbils or guinea pigs.

Not for use in known cases of hypersensitivity to penicillins or cephalosporins.

4.4 Special Warnings for each target species

No special warnings.

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.

Shake well before use. Following withdrawal of the first dose, use the product within 28 days. Discard unused material. This product does not contain an antimicrobial preservative. Swab the septum before removing each dose. Use a dry sterile needle and syringe.

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.

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 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 urgentmedical attention.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

Occasional local tissue reaction may occur with use of Amoxycare LA.

4.7 Use during pregnancy, lactation or lay

Amoxycare LA Injection can be safely administered during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

None.

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.

The recommended dosage rate is 15 mg per kg bodyweight, repeatable if necessary after 48 hours. Massage the injection site.

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

A separate injection site should be used for each administration.

Animal	Weight (kg)	Dosage volume (ml)
Cattle	450 kg	45.0 ml
Sheep	65 kg	6.5 ml
Pigs	150 kg	15.0 ml
Dogs	20 kg	2.0 ml
Cats	5 kg	0.5 ml

Dose volume is equivalent to 1 ml per 10 kg bodyweight. If dose volume exceeds 20 ml, it should be divided and injected into two sites. As with other injectable preparations normal aseptic precautions should be observed.

An appropriate graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important when injecting small volumes.

Not applicable.

Cattle

Meat: 23 days

Milk: 84 hours

Sheep

Meat: 16 days

Milk: contraindicated for use in sheep producing milk for human consumption.

Pigs

Meat: 16 days

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.

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

Do not store above 25ºC. Protect from light.

Following withdrawal of the first dose use the product within 28 days. Discard unused material.

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

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

- 50 ml, 100 ml, 250 ml and 500ml clear polyethylene terephthalate (PET) plastic vials sealed with nitrile 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: 02000/4141

9. DATE OF FIRST AUTHORISATION

Date:5November 1997

10. DATE OF REVISION OF THE TEXT

Date:October 2014

APPROVED 23/10/14