Revozyn RTU 400 mg/ml Suspension for Injection for Cattle

phase), because it could select antimicrobial-resistant bacteria (e.g. ESBL) 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
This veterinary medicinal product can cause sensitisation and contact dermatitis.
Hypersensitivity to penicillins may lead to cross reactions to cephalosporins, and vice
versa.
Allergic reactions to these substances may occasionally be serious.
Handle this product with great care to avoid direct skin contact or self-injection.
People with known hypersensitivity to penicillin should avoid contact with the
veterinary medicinal product.
Personal protective equipment consisting of gloves should be worn when handling
the veterinary medicinal product.
Wash hands after use.
In case of accidental contact with the skin, wash immediately with plenty of water. If
symptoms following exposure such as skin develop or in case of accidental self-
injection, seek medical advice immediately 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.
Special precautions for the protection of the environment
Not applicable.
4.6 Adverse reactions (frequency and seriousness)
Cattle (lactating cows):
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Urticaria, Anaphylactic shock
a
, death
a
.
Sensitisation against penicillins.
Undetermined frequency
(cannot be estimated from the
available data):
Skin reactions (mild), such as dermatitis
a
Anaphylactic shock can be fatal, very rarely

Revised: February 2023
AN: 00451/2022Page 3 of 5
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.
4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy or lactation.
4.8 Interaction with other medicinal products and other forms of interaction
The veterinary medicinal product should not be administered concurrently with
bacteriostatic antibiotics.
4.9 Amount(s) to be administered and administration route
Shake well before use.
For intramuscular administration only, preferably in the neck.
Administer alternately on the left and the right side.
Administer 10-15 mg penethamate hydriodide per kg body weight per day, once daily
for 3 consecutive days, corresponding to 2.5-3.75 ml of the veterinary medicinal
product per 100 kg body weight per day, once daily for 3 consecutive days.
Avoid underdosing. To ensure a correct dosage, body weight should be determined
as accurately as possible.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In case of overdose, no adverse effects other than those mentioned in section 4.6 are
to be expected.
4.11 Withdrawal period(s)
Milk: 4 days.
Meat and offal: 10 days.
5.