Duphamox La 150 Mg/Ml Suspension For Injection

Summary

Revised: March 2015

AN: 01594/2014

SUMMARY OF PRODUCT CHARACTERISTICS

NAME OF THE VETERINARY MEDICINAL PRODUCT

Duphamox LA 150 mg/ml suspension for injection

QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Substances: Per ml

Amoxicillin Trihydrate 150mg

Excipients:

Butylated Hydroxyanisole 0.08mg

Butylated Hydroxytoluene 0.08mg

For a full list of excipients, see section 6.1.

PHARMACEUTICAL FORM

Suspension for injection.

An off white oily suspension.

CLINICAL PARTICULARS

Target Species

Cattle
Sheep
Pigs
Dogs
Cats

Indications for use specifying the target species

For the treatment of infections caused by susceptible organisms including:

Escherichia coli
Proteus mirablis
Some Salmonella spp.
Staphylococci (non-penicillinase producing)
Streptococci (non-penicillinase producing)
Klebsiella pneumoniae

Not effective against beta-lactamase producing organisms. The product 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:

Alimentary tract

Respiratory tract

Skin and soft tissue

Urogenital tract, and

In prevention of post-operative infections (treat before surgery)

Contraindications

Not suitable for intravenous or intrathecal use.
Should not be used in rabbits, hamsters, gerbils or guinea pigs.
Not for use in known cases of hypersensitivity to penicillins or cephalosporins.

Special warnings for each target species

None

Special precautions for use

Special precautions for use in animals

Shake the container before use.

Swab the septum before removing each dose.

Use a dry, sterile needle and syringe.

This product does not contain an antimicrobial preservative.

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

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.

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

Handle this product with great care to avoid exposure, taking all recommended precautions.

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.

Adverse reactions (frequency and seriousness)

Occasional local tissue reaction may result from use of this product.
Not effective against beta-lactamase producing organisms.

Use during pregnancy, lactation or lay

Can be safely administered during pregnancy and lactation.

Interactions with other medicinal products and other forms of interaction

None known.

Amounts to be administered and administration route

Administration is by the intramuscular route for cattle, sheep and pigs and by the intramuscular or subcutaneous route in dogs and cats. The recommended dosage rate is 15 mg/kg bodyweight repeatable if necessary after 48 hours. The product is recommended for single administration only. Massage the injection site after injection. If dose volume exceeds 20ml in cattle or 10ml in sheep and pigs, it should be divided and injected into two sites.

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

Dose volume is equivalent to 1ml per 10kg bodyweight.

As with other injectable products, normal aseptic precautions should be observed.
An appropriately graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important when injecting small volumes.

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

Not applicable.

Withdrawal periods

Cattle - meat and offal: 23 days.

Cattle - milk: 84 hours.

Sheep and pigs - meat and offal: 16 days.

Not for use in sheep producing milk for human consumption.

PHARMACOLOGICAL PROPERTIES

Amoxicillin is a broad-spectrum semi-synthetic penicillin bactericidal in action. 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. After administration, amoxicillin is absorbed and widely distributed in the body and high levels are found in kidney, urine, liver and bile.

ATCVet Code:QJ01CA04

PHARMACEUTICAL PARTICULARS

List of excipients

Butylated Hydroxyanisole
Butylated Hydroxytoluene
Aluminium Stearate
Propylene Glycol Dicaprylocaprate

Incompatibilities

None known.

Shelf life

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

Shelf life after first opening the immediate packaging: 28 days.

Special precautions for storage

Do not store above 25°C.
Protect from light.

Nature and composition of immediate packaging

100 ml and 50 ml clear, colourless Type II or III multidose glass vials, closed with nitrile rubber bungs and aluminium overseals.

50 ml, 100 ml, 250 ml and 500 ml clear polyethylene terephthalate vials sealed with nitryl bungs and aluminium overseals.

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

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

MARKETING AUTHORISATION HOLDER

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

MARKETING AUTHORISATION NUMBER

Vm:42058/4044

DATE OF FIRST AUTHORISATION

Date:21 August 1986

DATE OF REVISION OF THE TEXT

Date:March 2015

APPROVED 31/03/15

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