SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the veterinary medicinal product

Alamycin LA 300 Solution for Injection 300 mg/ml.

2. Qualitative and quantitative composition

Active Substance: %w/v

Oxytetracycline 30.00

(as Oxytetracycline dihydrate 32.40)

Excipients:

Sodium Formaldehyde Sulphoxylate Anhydrous 0.40

For a full list of excipients, see section 6.1

3. Pharmaceutical form

Solution for injection

Clear dark amber liquid.

4. Clinical Particulars

4.1 Target species

Cattle,

Sheep,

Pigs

4.2 Indications for use, specifying the target species

For the treatment of conditions caused by or associated with organisms sensitive to oxytetracycline including:

Bordetella bronchiseptica

Actinomyces pyogenes

Erysipelothrix rhusiopathiae

Pasteurella spp

Staphylococcusspp

Streptococcus spp

Certain mycoplasma, rickettsiae, protozoa and chlamydia are also sensitive to oxytetracycline.

The product is indicated for the treatment and control of pasteurellosis, pneumonia, atrophic rhinitis, erysipelas, joint-ill, navel-ill, summer mastitis in cows, ovine keratoconjunctivitis (pink-eye) and enzootic abortion in sheep.

4.3 Contraindications

Do not dilute the product.

4.4 Special Warnings for each target species

Oxytetracycline therapy does not completely eliminate chlamydial infection in the flock.

4.5 Special precautions for use

Use of the product should be based on susceptibility testing of bacteria isolated from the animal. If this is not possiable, therapy should be based on local (regional, farm level) epidemiological information about susceptability of the target bacteria.

Special precautions for use in animals

If concurrent treatment is administered use a separate injection site.

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

Wash hands after use. In case of contact with eyes or skin, wash off immediately with water as irritation may occur. Avoid accidental self-injection.

4.6 Adverse reactions (frequency and seriousness)

Although the product is well tolerated, occasionally a slight local reaction of a transient nature may be observed.

4.7 Use during pregnancy, lactation or lay

The use of this product during the period of tooth and bone development, including late pregnancy, may lead to discoloration. The product can be safely administered during lactation.

4.8 Interaction with other medicinal products and other forms of interaction

None known

4.9 Amounts to be administered and administration route

To ensure a correct dosage, bodyweight should be determined as accurately as possible, to avoid under dosing.

Deep intramuscular injection.

Alamycin LA 300 can be administered at the standard dose of 20 mg/kg to obtain 3 to 4 days duration of activity or at a high dose of 30 mg/kg for prolonged duration of activity (i.e. activity maintained for 5 to 6 days).

Cattle, Sheep and Pigs: Standard dose - 20 mg/kg (1ml/15kg)

High dose - 30 mg/kg (1ml/10kg)

Maximum recommended dosage at one site:

Cattle 15 ml

Pigs 10 ml

Sheep 5 ml

Piglets 1 day: 0.2ml

7 days: 0.3 ml

14 days: 0.4 ml

21 days: 0.5 ml

Over 21 days: 1ml/10 kg

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

Excessive dosages can cause nephrotoxicity in cattle. No treatment specified.

Animals must not be slaughtered for human consumption during treatment.

20 mg/kg dose:

Cattle – Meat 28 days

Pigs – Meat 14 days

Sheep – Meat 28 days

30 mg/kg dose:

Cattle – Meat 35 days

Pigs – Meat 28 days

Sheep – Meat 28 days

Milk for human consumption must not be taken during treatment.

Cattle – Milk 10 days

Sheep – Milk 8 days.

5. pharmacological properties

Pharmacotherapeutic group: Antibacterial

ATC Vet Code: QJ01AA06

Oxytetracycline is a bacteriostatic antibiotic that inhibits protein synthesis in susceptible bacteria. Inside the cell it binds irreversibly to receptors on the 30S subunit of the bacterial ribosome where it interferes with the binding of the aminoactyl-transfer RNA to the acceptor site on the messenger RNA ribosome complex. This effectively prevents the addition of the amino acids to the elongating peptide chain, inhibiting protein synthesis.

The product is specifically formulated to provide a prolonged action, resulting in sustained antibacterial activity. Following intramuscular administration, effective blood levels persist for 3-4 days at a dose rate of 20mg/kg and for 5-6 days at a dose rate of 30mg/kg. Maximum blood levels are achieved between 4-6 hours following administration.

6. Pharmaceutical particulars

6.1 List of excipients

Sodium Formaldehyde Sulphoxylate Anhydrous

Magnesium Oxide Light

Dimethylacetamide

Ethanolamine (for pH adjustment)

Water for injections

None known.

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

Shelf life after 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 safely

This product does not contain any microbial preservative.

100 ml, 250 ml and 500 ml amber glass Type I vial with bromobutyl rubber bung with aluminium seal.

Not all pack sizes may be marketed.

Any unused product or waste material should be disposed of in accordance with national requirements.

7. MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Newry

Co. Down, BT35 6JP

Northern Ireland

8. MARKETING AUTHORISATION NUMBER(S)

Vm: 02000/ 4113

9. DATE OF FIRST AUTHORISATION

13^thDecember 1993

10. DATE OF REVISION OF THE TEXT

February 2009