Procactive 300 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 cephalosporins may cause hypersensitivity (allergy) following injection,
inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead to cross
sensitivity to cephalosporins and vice versa. Allergic reaction to these substances
may occasionally be serious. This veterinary medicinal product also contains a
paraben preservative which may cause a contact hypersensitivity reaction in
previously sensitised individuals.
1. People with known hypersensitivity to this veterinary medicinal product, or if you
have been advised not to work with such preparations, should avoid contact with the
veterinary medicinal product.
2. Handle this veterinary medicinal product with great care to avoid exposure,
taking all recommended precautions.
3. If you develop symptoms following exposure, such as a skin rash, you should
seek medical advice 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.
People developing a reaction after contact with the veterinary medicinal product
should avoid handling the veterinary medicinal product and other penicillin and
cephalosporin containing products in the future.
Personal protective equipment consisting of gloves should be worn when handling
and administering the veterinary medicinal 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.
Special precautions for the protection of the environment:
Not applicable
3.6 Adverse events
Cattle:
Rare
(1 to 10 animals / 10,000 animals
treated):
Anaphylactic-type reaction
,
Hypersensitivity reaction
,
Anaphylactic shock
1.
May be caused by the content of povidone.
2.
Penicillins and cephalosporins may cause this following administration of the
product. May occasionally be serious.
Pigs:
Rare
(1 to 10 animals / 10,000 animals
treated):
Pyrexia
, Apathy
, Systemic disorder
NOS
Vomiting
Shivering
, Incoordination
Vaginal discharge
Hypersensitivity reaction
,
Anaphylactic shock
1.
In suckling and fattening pigs which may be caused by the release of
procaine
2.
Toxic effects have been observed in young piglets, which are transient but
can be potentially lethal, especially at higher doses
3.
In pregnant sows and gilts could be associated with abortion.
4.
Penicillins and cephalosporins may cause this following administration of
the product. May occasionally be serious.
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
There is no evidence that this veterinary medicinal product presents any particular
hazard to the dam or foetus.
Laboratory studies in animals have not produced any evidence of teratogenic,
foetotoxic or maternotoxic effects.
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.
Pregnancy and lactation:
Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
3.8 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.
3.9 Administration routes and dosage
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.
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.
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.
The use of suitability calibrated measuring equipment is recommended.
The cap may be safely punctured up to 50 times.
3.10 Symptoms of overdose (and where applicable, emergency procedures and
antidotes)
In the case of overdose, central nervous symptoms and/or convulsions may occur.
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
3.12 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)
4.