Procactive 300 mg/ml Suspension for Injection for Cattle, Sheep 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
Penicillins and cephalosporins may cause hypersensitivity (allergy) following
injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead
to cross sensitivity to cephalosporins and vice versa. Allergic reactions to these
substances may occasionally be serious. This product also contains a paraben
preservative which may cause a contact hypersensitivity reaction in previously
sensitised individuals.
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.

Revised: January 2026
AN: 00471/2025
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 and
eyes or difficulty with breathing are more serious symptoms and require urgent
medical attention.
People developing a reaction after contact with the product should avoid handling the
product and other penicillin and cephalosporin containing products in the future.
It is recommended to wear gloves when handling and administering the product.
In case of accidental eye contact, rinse thoroughly with water.
In case of accidental skin contact wash exposed skin thoroughly with soap and
water.
In case of accidental self-injection, seek medical advice immediately and show the
package leaflet or the label to the physician.
4.6 Adverse reactions (frequency and seriousness)
In suckling and fattening pigs, pyrexia, vomiting, shivering, listlessness and
incoordination have been reported rarely, which may be caused by the release of
procaine.
Systemic toxic effects have been observed in young piglets, which are transient but
can be potentially lethal, especially at higher doses.
In pregnant sows and gilts, a vulvar discharge which could be associated with
abortion has been reported rarely.
In cattle, anaphylactic reactions have been reported rarely, which may be caused by
the content of povidone.
Penicillins and cephalosporins may cause hypersensitivity (allergy) following
administration of the product. Allergic reactions to these substances may
occasionally be serious and include anaphylactic shock.
In case of side effects, the animal has to be treated symptomatically.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- 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
There is no evidence that this product presents any particular hazard to the dam or
foetus.
The safety of the veterinary medicinal product has not been established during
pregnancy and lactation. However, in pregnant sows and gilts, a vulvar discharge
which could be associated with abortion has been reported.
Use during pregnancy and lactation only accordingly to the benefit/risk assessment
by the responsible veterinarian.

Revised: January 2026
AN: 00471/2025
4.8 Interaction with other medicinal products and other forms of interaction
The bactericidal efficacy of penicillin is counteracted by bacteriostatic medicinal
products.
The effect of aminoglycosides can be enhanced by penicillins.
The excretion of benzylpenicillin is prolonged by acetylsalicylic acid.
Cholinesterase inhibitors delay the degradation of procaine.
4.9 Amounts to be administered and administration route
For intramuscular use. Shake well before use.
The recommended dosage rate is 10 mg/kg bodyweight procaine benzylpenicillin
(corresponding to 5.66 mg benzylpenicillin/kg bodyweight) equivalent to 1 ml per
30 kg bodyweight daily. The treatment duration is 3 to 7 days.
Do not inject more than 2.5 ml per injection site in pigs.
Do not inject more than 12 ml per injection site in cattle.
Do not inject more than 2 ml per injection site in sheep.
If no clinical response is seen within 3 days, redetermine the diagnosis and change
the treatment if necessary.
The appropriate treatment duration should be chosen based on the clinical needs
and individual recovery of the treated animal. Consideration should be given to the
accessibility of the target tissue and characteristics of the target pathogen.
To ensure a correct dosage, body weight should be determined as accurately as
possible to avoid underdosing.
The cap may be safely punctured up to 50 times.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In the case of overdose, central nervous symptoms and/or convulsions may occur.
4.11 Withdrawal periods
Pigs:
Meat and offal: 6 days for treatment duration 3-5 days
8 days for treatment duration 6-7 days
Cattle:
Meat and offal: 6 days for treatment duration 3-5 days
8 days for treatment duration 6-7 days
Milk: 96 hours (4 days)
Sheep:
Meat and offal: 4 days for treatment duration 3-5 days
6 days for treatment duration 6-7 days
Milk: 156 hours (