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Clinical particulars
Target species
Cattle, sheep, pigs, dogs and cats.
Indications for use
Amfipen LA is indicated for treatment of diseases or secondary infections due to the following bacteria sensitive to ampicillin in dogs, cats, cattle, sheep and pigs and where prolongation of activity from a single injection is required: Streptococcus spp., Trueperella pyogenes, Mannheimia haemolytica, Pasteurella multocida, Erysipelothrix rhusiopathiae, Staphylococcus aureus and Staphylococcus species.
Contraindications
Do not use in case of hypersensitivity to the active substance, or to any of the excipients.
Do not administer to rabbits, hamsters or guinea pigs. Not effective against beta-lactamase producing organisms.
Do not use this product in horses due to the likelihood of severe local reaction at the injection site.
Do not inject dogs and cats intramuscularly.
Do not use in animals producing milk for human consumption.
Special warnings for each target species
Severe disturbances of the intestinal bacterial flora of herbivores may occur.
Special precautions for use
Whenever possible, the product should only be used based on susceptibility testing.
Official and local antimicrobial policies should be taken into account when the product is used.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to ampicillin and may decrease the effectiveness of treatment with other beta-lactams due to the potential for cross-resistance.
Operator warnings
Penicillin and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.
1. Do not handle this product if you know you are sensitised or if you have been advised not to work with such preparations.
2. Handle this product with great care to avoid exposure, taking all recommended precautions.
3. If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
Care should be taken to avoid accidental self-injection. In case of accidental self-injection, seek medical advice immediately. Wash hands after use.
Adverse reactions
Severe disturbances of the intestinal bacterial flora of herbivores may occur.
Allergies to ampicillin can occur rarely. Local swelling at the injection site may occur in dogs, this usually regresses spontaneously in 2-4 days.
Use during pregnancy or lactation
No special precautions necessary.
Interactions
Bacteria, particularly gram-negative organisms, that show a cross-resistance with other ß lactam antibiotics may show resistance.
There is antagonism between this product and antibiotics with bacteriostatic activity.
Amounts to be administered and administration route
Dosage:
Cattle and sheep 15 mg/kg, pigs 25 mg/kg by intramuscular route.
Dogs 15 mg/kg, cats 20 mg/kg by subcutaneous route.
e.g.
Cow
500 kg
75 ml
Sheep
50 kg
7.5 ml
Pig
50 kg
12.5 ml
Dog
10 kg
1.5 ml
Cat
5 kg
1 ml
Shake well before use. Clean the area of the injection site and swab with spirit. This product does not contain an antimicrobial preservative.
Only dry sterile needles and syringes should be used for administration and the septum should be swabbed before removing each dose. Do not use the same injection site more than once during a course of treatment. Do not administer more than 10 ml per injection site in pigs and sheep and 20 ml in cattle. Treatment may be repeated once after 48 hours.
To ensure a correct dosage, body weight should be determined as accurately as possible to avoid under dosing.
Overdose
Ampicillin is a compound with a very high therapeutic ratio. It is unlikely that an overdose of Amfipen LA will have adverse effects on the treated animal. No specific antidote or treatment is recommended.
Withdrawal periods
Meat and offal
Cattle, pigs and sheep: 60 days
Not authorised for use in animals producing milk for human consumption.