Novomate 277.8 mg/ml Powder and Solvent for Suspension for Injection for Cattle

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
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.
Do not handle this product if you know you are sensitised to penicillins or any of the
excipients, or if you have been advised not to work with such preparations.

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Handle the product with great care to avoid exposure, taking all recommended
precautions.
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 breathing are more serious symptoms and require urgent medical attention.
Care should be taken to avoid accidental selfinjection and contact with the skin. In
case of accidental self‐injection, seek medical advice immediately.
Wash hands after use.
4.6 Adverse reactions (frequency and seriousness)
Animals may experience discomfort or pain upon administration of the product.
Minimal swelling, which should resolve without treatment, may be observed at the
injection site after administration of the product.
In very rare cases anaphylactic shock may occur, which can be fatal.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
4.7 Use during pregnancy, lactation or lay
Pregnancy:
Can be used during pregnancy.
Lactation:
Can be used during lactation.
4.8 Interaction with other medicinal products and other forms of interaction
Penicillins should not be administered concurrently with bacteriostatic antibiotics.
4.9 Amounts to be administered and administration route
For intramuscular use.
Reconstitution: Reconstitute the suspension by using a suitably scaled syringe to add
exactly 15 ml solvent to the contents of the 5 g powder vial OR exactly 30 ml solvent
to the contents of the 10 g powder vial, giving reconstituted volumes of 18 ml and 36
ml respectively. Once broached, the solvent vial with any residual solvent must be
discarded.
Use only 5 g vial with 15 ml diluent and 10 g vial with 30 ml diluent to provide the
correct dose.
Shake well after reconstitution and before each use.

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Dosage:
The dose is 15 mg penethamate hydriodide per kg bodyweight.
This is equivalent to 5.4 ml of the reconstituted suspension per 100 kg bodyweight.
Shake well before administration.
The injection should be repeated with a time interval of 24 hours for 4 consecutive
days in total.
The injection site volume should not exceed a maximum of 20 ml per injection site.
To ensure a correct dosage, bodyweight should be determined as accurately as
possible to avoid under-dosing.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
None known.
4.11 Withdrawal period(s)
Meat and offal: 10 days
Milk: 96 hours
5.