Redymox 150 mg/ml Suspension for Injection for Cattle, Sheep, Pigs, Dogs and Cats

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
Care should be taken to avoid accidental self-injection. In the case of accidental self-
injection, seek medical advice immediately and show the package leaflet or the label
to the physician.
Penicillins and cephalosporins may cause hypersensitivity (allergy) following
injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins 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 skin rash, you should seek
medical advice and show the package leaflet or the label to the physician. Swelling
of the face, lips or eyes or difficulty with breathing, are more serious symptoms and
require urgent medical attention.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
Other precautions:
Not applicable.
3.6 Adverse events
Cattle, sheep, pigs, dogs, cats:
Rare
(1 to 10 animals / 10,000 animals
treated):
Injection site irritation
Very rare
(<1 animal/ 10,000 animals treated,
including isolated reports):
Allergic reaction (e.g. anaphylactic shock
and urticaria)
2,3
Typically of low intensity and recedes spontaneously and quickly. Frequency may
be decreased by reducing the volume of injection per injection site.
treatment should be discontinued and symptomatic treatment should be initiated.
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 also the last section of the package leaflet for respective contact details.
3.7 Use during pregnancy, lactation or lay
Pregnancy and Lactation:
Can be used during pregnancy and lactation.
3.8 Interaction with other medicinal products and other forms of interaction
It is not generally recommended to use bactericidal and bacteriostatic antibiotics at
the same time.
Beta-lactam antibiotics are known to interact with antibiotics with bacteriostatic action
such as chloramphenicol, macrolides, sulfonamides and tetracyclines. There is also
synergic action of penicillins with aminoglycosides.
3.9 Administration routes and dosage
Cattle, sheep and pigs : By intramuscular injection only.
Dogs and cats : By subcutaneous or intramuscular injection.
Shake the vial vigorously to achieve full resuspension before use.
This product does not contain an antimicrobial preservative.
Swab the septum before removing each dose.
To ensure the correct dosage, bodyweight should be determined as accurately as
possible to avoid underdosing.
The dosage rate is 7 mg/kg once daily for up to 5 days in all species.
Massage the injection site.
AnimalWeight (kg)Dosage volume (ml)Cattle450 kg20.0 mlSheep65 kg3.0 mlPigs150 kg7.0 mlDogs20 kg1.0 mlCats5 kg0.25 ml
(Guide-dose volume is approximately equivalent to 0.25 ml per 5 kg daily).
Normal aseptic precautions should be observed.
If dose volume exceeds 20 ml in cattle or 10 ml in pigs, it should be divided and
injected into two sites.
The stopper should not be punctured more than 40 times.
3.10 Symptoms of overdose (and where applicable, emergency procedures
and antidotes)
The safety of amoxicillin is typical of that of other penicillins in that intrinsic toxicity is
very low. Amoxicillin has a wide safety margin.
In case of overdose, treatment is symptomatic.
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: 24 hours.
Sheep
Meat and offal: 10 days.
Not authorised in sheep producing milk for human consumption.
Pigs
Meat and offal: 16 days.
4.