NOAH Compendium

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Date: Thursday, July 9, 2020 13:58

Release 2.120
Alamycin LA 200 mg/ml Solution for Injection
 
Species: Cattle, Pigs, Sheep
Therapeutic indication: Pharmaceuticals: Antimicrobials: Injections
Active ingredient: Oxytetracycline
Product:Alamycin LA 200 mg/ml Solution for Injection
Product index: Alamycin LA Injection
Cattle - milk: 8 days
Cattle - meat: 41 days
Sheep - meat: 24 days
Pig - meat: 20 days
Withdrawal notes: Sheep Milk: 7 days
Qualitative and quantitative composition
Active substance(s):
Oxytetracycline
200 mg
(Equivalent to Oxytetracycline Dihydrate)
216 mg
Excipients:
Sodium Formaldehyde Sulphoxylate
2 mg
For a full list of excipients, see section Pharmaceutical Particulars
Pharmaceutical form
Solution for injection.
A clear amber solution.
Clinical particulars
Target species
Cattle, sheep and pigs.
Indications for use, specifying the target species
The product is indicated for use in cattle, sheep and pigs in the treatment of:
Atrophic rhinitis caused by Bordetella bronchiseptica, Mannheimia haemolytica and Pasteurella multocida.
Navel/joint ill caused by Trueperella pyogenes, E. coli or Staphylococcus aureus.
Mastits caused by Corynebacterium pyogenes, E. coli, Staphylococcus aureus, Streptococcus agalactiae or Streptococcus uberis.
Metritis caused by E. coli or Streptococcus pyogenes.
Pasteurellosis and infections of the respiratory tract caused by Mannheimia haemolytica and Pasteurella multocida.
Septicaemia caused by Salmonella dublin and Streptococcus pyogenes.
Erysipelas caused by Erysipelothrix rhusiopathiae.
The product can also be used in the control of enzootic abortion in sheep.
Contraindications
Not for use in horses, dogs, cats.
Not for use in animals suffering from hepatic or renal damage.
Special Warnings for Each Target Species
No special warnings.
Special Precautions for Use
Special Precautions for use in animals
Do not dilute the product.
If concurrent treatment is administered, use a separate injection site.
Special precautions to be taken by the person administering the product to the animals
Wash hands after use. In case of contact with eyes or skin, wash immediately with plenty of water as irritation may occur.
Take care to avoid accidental injection.
Adverse reactions (frequency and seriousness)
Although the product is well tolerated, occasionally a slight local reaction of a transient nature has been observed.
Use during pregnancy, lactation or lay
The use of oxytetracycline during the period of tooth and bone development, including late pregnancy may lead to tooth discoloration, the product can be safely administered to lactating animals.
Interactions with other medicinal products and other forms of interaction
None known.
Amount to be administered and administration route
The recommended dose rate is 20 mg/kg bodyweight (i.e. 1 ml per 10 kg bodyweight) administered by deep intramuscular injection. The product is recommended for a single administration only.
Maximum recommended dose at any one site:
Cattle: 20ml
Pigs: 10ml
Sheep: 5ml
Piglets:
1 day 0.2ml
7 days 0.3ml
14 days 0.4ml
21 days 0.5ml
Over 21 days 1.0 ml/10kg.
Overdose (symptoms, emergency procedures, antidotes) (if necessary)
There is no known specific antidote, if signs of possible overdose occur, treat the animal symptomatically.
Withdrawal periods
Cattle:
Meat – 41 days
Milk – 8 days
Sheep:
Meat – 24 days
Milk – 7 days
Pigs:
Meat – 20 days
Pharmacological particulars
Pharmacotherapeutic group: Antibiotic
ATCvet Code: QJ01AA06
Pharmacodynamic properties
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 aminoacyl-transfer RNA to the acceptor site on the messenger RNA ribosome complex. This effectively prevents the addition of 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.
Oxytetracycline had been shown to be effective in vitro against the following bacterial species: Bordetella bronchiseptica, Corynebacterium pyogenes, Erysipelothrix rhusiopathiae, Escherichia coli, Histophilus somni, Pasteurella haemolytica, Pasteurella multocida, Salmonella dublin, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus faecalis, Streptococcus pyogenes and Streptococcus uberis.
Pharmacokinetic properties
Blood levels persist for at least 4 days after administration by the intramuscular route. Maximum blood levels are achieved between 4 and 8 hours following intramuscular administration.
Pharmaceutical particulars
List of excipients
Sodium formaldehyde sulphoxylate
Magnesium Oxide Light
2-Pyrrolidone
Povidone K12
Monoethanolamine
Hydrochloric Acid
Water for Injections
Major Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
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.
Following withdrawal of the first dose, use the product within 28 days.
Discard unused material
When the vial has been broached and contents exposed to air, the solution may darken but the potency will be unchanged.
Nature and composition of immediate packaging
Amber type II glass vials of 50 ml and 100 ml sealed with Chlorobutyl Rubber Bungs and aluminium seal.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal products 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 (if different from distributor)
Norbrook Laboratories Limited
Station Works
Newry
Co. Down
BT35 6JP
Northern Ireland
Marketing Authorisation Number
Vm 02000/4117
Significant changes
Date of the first authorisation or date of renewal
20 October 1993
Date of revision of the text
January 2020
Any other information
Nil.
Legal category
Legal category: POM-V
GTIN
GTIN description:Alamycin LA Injection 100ml
GTIN:5023534000112