SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF VETERINARY MEDICINAL PRODUCT

TETROXY L.A.

200mg/ml Oxytetracyline Solution for Injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Substance

Oxytetracycline

(as Oxytetracycline Dihydrate) 200 mg/ml .

Excipient(s)

Polyvinylpyrrolidone (K - 17) Co-solvent

N-Methyl Pyrrolidone Co-solvent

For full list of excipients refer to section 6.1

3. PHARMACEUTICAL FORM

Solution for injection.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle, Sheep and Pigs.

4.2 Indications for use, specifying the target species

Tetroxy L.A. is indicated in the treatment and control of diseases caused by or

associated with organisms sensitive to Oxytetracycline in cattle, sheep and

pigs.

4.3 Contraindications

Not recommended for cats, dogs, horses and donkeys.

4.4 Special warnings for each target species

Prolonged use of anti-infectives may result in super infection by non-susceptible organisms. Photodermatitis may occasionally occur after treatment under strong exposure to sunlight.

4.5 Special precautions for use

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

Not recommended in cases of renal impairment (see also 4.4 above). Discard unused material.

Take care to avoid accidental self injection. In case of contact with eyes or skin, wash immediately with plenty of water as irritation may occur. Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

Occasional local reaction of a transient nature may occur at the site of injection.

4.7 Use during pregnancy, lactation or lay

The use of Tetroxy L.A. during the period of tooth development including late

Pregnancy may lead to discoloration.

4.8 Interaction with other medicinal products and other forms of interactions

Do not dilute. It is unwise to administer bacteriostatic and bactericidal

antibiotics concurrently.

4.9 Amounts to be administered and administration route

Tetroxy L.A. is administered by deep intramuscular injection at the rate of 1 ml

per 10kg bodyweight which is equivalent to 20mg Oxytetracycline per kg.

It is recommended that the following amounts of Tetroxy L.A. at one site should

not be exceeded:

Cattle and Sheep - 10 ml

Pigs - 5 ml

Pigs under 10 kg - maximum dose of 1 ml

Effective blood levels are maintained for up to 72 hours in cattle and 48 hours in pigs and sheep.

Because of the sustained blood levels attained at the above dosage rates with

Tetroxy L.A., this is a single dose treatment.

4.10 Overdose

Not applicable.

4.11 Withdrawal Periods

Cattle (meat & offal): 39 days

Pigs (meat & offal): 40 days

Sheep (meat & offal): 28 days

Do not use in animals producing milk for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Tetroxy L.A. is a multidose injection product containing Oxytetracycline

Dihydrate Ph. Eur. equivalent to 200mg Oxytetracycline per ml.

The product is long acting and is intended to be administered as a single

dose. Effective blood levels are maintained for up to 72 hours in cattle and 48

hours in pigs and sheep. Long acting antibiotic preparations are not only

convenient but may also provide more constant blood and tissue drug

concentrations by avoiding the peaks and troughs associated with conventional

administration

Tetroxy L.A. is recommended for the treatment and control of diseases in cattle,

sheep and pigs caused by or associated with organisms sensitive to Oxytetracycline.

Oxytetracycline is a broad spectrum antibiotic of the tetracycline group. The drug was discovered in the 1950’s. It is derived from a soil mould, Actinomyces rimosus.Oxytetracycline is bacteriostatic at therapeutic concentration but may be bactericidal at higher concentrations.

The mode of action of Oxytetracycline and other tetracyclines involves interference with protein and RNA synthesis in the growing and reproducing bacterial cell.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Magnesium Oxide Heavy, N-Methyl Pyrrolidone, Pvidone K17, Sodium Formaldehyde Sulphoxylate as Sodium Formaldehyde Sulphoxylate Dihydrate, Ethanolamine, Hydrochloric Acid, Water for Injection

6.2 Incompatibilities

Tetroxy L.A. should not be brought into contact with calcium solutions. Do not

dilute.

6.3 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.

Discard unused material.

6.4 Special precautions for storage

Do not store above 25°C.

Protect from light.

6.5 Nature and contents of immediate packaging

100ml amber Type II glass vials, fitted with bromobutyl rubber stoppers and

sealed with plain aluminium caps containing a clear yellow to amber sterile

aqueous solution.

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

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

7. MARKETING AUTHORISATION HOLDER

Bimeda Chemicals Ltd.

Broomhill Road,

Tallaght,

Dublin 24.

Ireland.

8. MARKETING AUTHORISATION NUMBER

Vm02676/4137.

9. DATE OF THE FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

12 November 1990

10. DATE OF REVISION OF THE TEXT

February 2011