Alamycin Aerosol 3.2% w/v Cutaneous Spray, solution
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 140g aerosol can contains:
Active Substance
Oxytetraycline 3.2 % w/v
(as oxytetracycline hydrochloride)
Excipient
Patent Blue V (E131) 0.3 % w/v
PHARMACEUTICAL FORM
Cutaneous Spray, solution
A blue opaque solution
Target Species
Cattle, sheep and pigs.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Alamycin Aaerosol is indicated for topical use in the treatment of foot rot in sheep and topical infections caused by organisms sensitive to oxytetracycline in cattle,sheep and pigs.
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active substance.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
SPECIAL PRECAUTION(S) FOR USE IN ANIMALS
For external use only.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
Keep away from eyes.
Use only in a well ventilated area.
Avoid inhalation and contact with skin.
Wash hands after use.
Wash any splashes immediately.
Do not spray on a naked flame or any incandescent material.
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
USE DURING PREGNANCY, LACTATION OR LAY
No adverse effects or foetal abnormalities have been observed following the administration of oxytetracycline aerosol during pregnancy or lactation.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
None known.
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
Foot Rot
For the treatment of foot rot, clean the affected area prior to administration. Holding the can upright, spray at a distance of 6 – 8 inches away for a minimum of 5 seconds or until the area is covered.
Treated sheep should be allowed to stand on dry ground for one hour before returning to pasture
Wounds:
Wounds should be cleaned prior to application
OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES), if necessary
Not applicable.
WITHDRAWAL PERIOD(S)
Meat: 0 days
Milk: 0 hours
PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic Group: Antibiotics for topical use; Oxytetracycline.
ATCvet Code: QD06AA03.
Pharmacodynamic properties
Oxtetracycline is a bacteriostatic antibiotic that inhibits protein synthesis in susceptible bacteria. Inside thecell it binds irreversibly to receptors on the 30S subunit of the bacterial ribosome where it interferes withthe 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 proteinsynthesis.
PHARMACEUTICAL PARTICULARS
List of excipients
Patent Blue V (E131)
Magnesium chloride
Povidone
Propylene Glycol
Ethanolamine
Purified Water
Isopropyl Alcohol
Methyl Alcohol
INCOMPATIBILITIES
None known.
SHELF-LIFE
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years
SPECIAL PRECAUTIONS FOR STORAGE
Pressurised container, protect from sunlight and do not expose to temperatures above 50°C.
Store below 25°C.
NATURE AND COMPOSITION OF IMMEDIATE PACKAGING
140g pressurised aluminium can with valves, caps and actuators.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS
Do not incinerate or puncture the can even when empty.
Unused product or waste material should be disposed of in accordance with current practice for pharmaceutical waste under national waste disposal regulations.