Alamycin La 300 Solution For Injection 300 Mg/Ml
Revised: 09 February 2009
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
(as Oxytetracycline dihydrate 32.40)
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
4.2 Indications for use, specifying the target species
For the treatment of conditions caused by or associated with organisms sensitive to oxytetracycline including:
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.
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
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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
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
Ethanolamine (for pH adjustment)
Water for injections
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after opening the immediate packaging: 28 days
Special precautions for storage
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.
Nature and composition of immediate packaging
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.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused product or waste material should be disposed of in accordance with national requirements.
7. MARKETING AUTHORISATION HOLDER
Norbrook Laboratories Limited
Co. Down, BT35 6JP
8. MARKETING AUTHORISATION NUMBER(S)
Vm: 02000/ 4113
9. DATE OF FIRST AUTHORISATION
10. DATE OF REVISION OF THE TEXT