Citramox L.A. 150 mg/ml Suspension for Injection for Cattle and Pigs

phase), because it could select antimicrobial-resistant bacteria within the intestinal
microbiota of the calf and increase the faecal shedding of these bacteria
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
Penicillin and cephalosporin may cause an allergic reaction following accidental
injection, inhalation ingestion or absorption via the skin, which may be life
threatening.
Hypersensitivity to penicillin may lead to cross sensitivity to cephalosporins and vice
versa. People with known hypersensitivity to penicillins or cephalosporins, should
avoid contact with the veterinary medicinal product. Handle the veterinary medicinal
product with great care to avoid exposure.
Personal protective equipment consisting of gloves should be worn when handling
the veterinary medicinal product. Wash hands after use of the veterinary medicinal
product.
In case of accidental exposure to the skin or eyes, wash immediately with plenty of
water.
Do not smoke, eat or drink during use of the veterinary medicinal product.
If you develop symptoms following exposure, such as a skin rash, seek medical
advice immediately and show the package leaflet or the label to the physician.
Swelling of the face, lips and eyes or difficulty with breathing are more serious
symptoms and require urgent medical attention.
Special precautions for the protection of the environment:
Not applicable.
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3.6 Adverse events
Cattle:
Undetermined frequency
(cannot be estimated from the
available data):
Hypersensitivity reaction
(e.g. urticaria,
anaphylactic shock)
Elevated liver enzymes
Injection site reaction
, Injection site swelling
1
varying in severity
of low intensity and recedes spontaneously and quickly
Pigs:
Undetermined frequency
(cannot be estimated from the
available data):
Hypersensitivity reaction
(e.g. urticaria,
anaphylactic shock)
Elevated liver enzymes
Injection site induration
varying in severity
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or its local representative or the national
competent authority via the national reporting system. See the package leaflet for
respective contact details.
3.7 Use during pregnancy, lactation or lay
Pregnancy and lactation:
Laboratory studies in rats and rabbits have not produced any evidence of
teratogenic, foetotoxic or maternotoxic effects of amoxicillin. However, the safety of
the veterinary medicinal product has not been established during pregnancy and
lactation. Use only according to the benefit-risk assessment by the responsible
veterinarian.
3.8 Interaction with other medicinal products and other forms of interaction
Do not use with antibiotics, which inhibit bacterial protein synthesis, as these can
antagonise the bactericidal action of penicillins.
Because there is evidence of in vitro
bacteriostatic antibiotics (e.g. chloramphenicol, erythromycin and other macrolides,
tetracyclines, sulfonamides, etc.), use together has been generally not
recommended, but actual clinical importance is not clear. There is also synergic
action of penicillins with aminoglycosides.
Amoxicillin may decrease the renal excretion of methotrexate causing increased
levels and potential toxic effects.
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Probenecid competitively blocks the tubular secretion of most penicillins, thereby
increasing serum levels and serum half-lives.
3.9 Administration routes and dosage
Intramuscular use.
To ensure a correct dosage, body weight should be determined as accurately as
possible.
15 mg amoxicillin per kg bodyweight; corresponding to 1 ml of the veterinary
medicinal product per 10 kg. Administration should be repeated once after 48 hours.
In cattle, do not administer more than 20 ml of the veterinary medicinal product per
injection site.
In pigs, do not administer more than 6 ml of the veterinary medicinal product per
injection site.
A separate injection site should be used for each administration.
Shake the vial vigorously to achieve full resuspension before use. As with other
injectable preparations normal aseptic precautions should be observed.
For 100 ml vials:
Do not broach the vial more than 15 times: if necessary, use automatic syringes.
For 250 ml vials:
Do not broach the vial more than 20 times: if necessary, use automatic syringes.
3.10 Symptoms of overdose (and where applicable, emergency procedures and
antidotes)
Amoxicillin has a wide safety margin. In case of overdose, treatment is symptomatic.
High doses or very prolonged use have been associated with neurotoxicity.
3.11 Special restrictions for use and special conditions for use, including
restrictions on the use of antimicrobial and antiparasitic veterinary
medicinal products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Cattle:
Meat and offal: 18 days
Milk: 3 days
Pigs:
Meat and offal: 20 days
4.