Bimprocil 300 mg/ml Suspension for Injection for Cattle Sheep and Pigs

Excipients:
Qualitative composition of excipients
and other constituents
Quantitative composition if that
information is essential for proper
administration of the veterinary
medicinal product
Methyl parahydroxybenzoate E218 2.0 mgPovidone K30Sodium citrateDisodium edetateLecithinPotassium dihydrogen phosphatePotassium chlorideWater for injections
An off-white suspension.
3. CLINICAL INFORMATION
3.1 Target species
Cattle, sheep and pigs.
3.2 Indications for use for each target species
For the treatment of acute systemic infections caused by bacteria susceptible to
benzylpenicillin.
3.3 Contraindications
Do not inject intravenously.
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Do not use in cases of hypersensitivity to penicillin, cephalosporins, procaine or to
any of the excipients.
Do not use in cases of severe renal dysfunction with anuria and oliguria.
Do not use in very small herbivores such as guinea pigs, gerbils and hamsters.
Do not use in the presence of β-lactamase producing pathogens.

3.4 Special warnings
Complete cross-resistance has been shown between benzylpenicillin procaine and
other penicillins.
After absorption, benzylpenicillin poorly penetrates biological membranes (e.g.,
blood-brain barrier) since it is ionised and poorly lipid soluble. Use of the veterinary
medicinal product for treatment of meningitis or CNS infections due to e.g.,
Streptococcus suis may not be efficacious. Furthermore,
benzylpenicillin penetrates mammalian cells poorly and hence this veterinary
medicinal product may have little effect in treating intracellular pathogens e.g.,
Listeria monocytogenes.
Elevated MIC values or bi-modal distribution profiles suggesting acquired resistance
have been reported for the following bacteria:
- Glaesserella parasuis, Staphylococcus spp. causing MMA/PPDS, Streptococcus
spp. and S. suis in pigs.
- Fusobacterium necrophorum causing metritis and Mannheimia haemolytica (only in
some member states), as well as Bacteroides spp., Staphylococcus chromogenes,
Actinobacillus lignieresii and Trueperella pyogenes in cattle.
Use of the veterinary medicinal product may result in a lack of clinical efficacy when
treating infections caused by these bacteria.
3.5 Special precautions for use
Special precautions for safe use in the target species:
Use of the veterinary medicinal product should be based on susceptibility testing of
the bacteria isolated from the animal. If this is not possible, therapy should be based
on local (regional, farm level) epidemiological information about susceptibility of the
target bacteria.
Official, national and regional antimicrobial policies should be taken into account
when the veterinary medicinal product is used.
Use of the veterinary medicinal product deviating from the instructions given in the
SPC may increase the prevalence of bacteria resistant to benzylpenicillin and may
decrease the effectiveness of treatment with other penicillins and cephalosporins due
to the potential for cross-resistance.
The feeding of waste milk containing residues of antibiotics to calves should be
avoided up to the end of the milk withdrawal period (except during the colostral
phase), because it could select antimicrobial-resistant bacteria within the intestinal
microbiota of the calf and increase the faecal shedding of these bacteria.
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Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Penicillins and cephalosporins may cause sensitisation 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.
This veterinary medicinal product also contains a paraben preservative which may
cause a contact hypersensitivity reaction in previously sensitised individuals.
Do not handle this product if you know that you are sensitised, or if you have been
advised not to work with such preparations. People developing a reaction after
contact with the product should avoid handling the 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.
Handle this product with care to avoid exposure.
In case of accidental contact with eyes, rinse immediately with copious amounts of
water. Accidental spillage on the skin should be washed immediately 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.
If you develop symptoms such as a skin rash following exposure, seek medical
advice and show this warning to the doctor. Swelling of the face, lips, eyes, or
difficulty with breathing are more serious symptoms and require urgent medical
attention.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
Pigs:
Uncommon
(1 to 10 animals / 1 000 animals
treated):
Pyrexia
, Vomiting
, Shivering
, Listless
,
Incoordination
Undetermined frequency (cannot be
estimated from the available data)
Systemic disorder
, Vaginal discharge
1
Suckling and fattening pigs, transient
Toxic effects have been observed in young piglets. Transient but can be potentially
lethal, especially at higher doses
In pregnant sows and gilts, could be associated with abortion
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Cattle:
Rare
(1 to 10 animals / 10 000 animals
treated):
Anaphylactic type reactions
Very rare
(<1 animal / 10 000 animals treated,
including isolated reports):
Allergic reaction
, Anaphylactic shock
1
Due to povidone content
To penicillin, may be serious
Sheep: None known
In case of side effects, the animal should be treated symptomatically.
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 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
Pregnancy and lactation:
There is no evidence that this veterinary medicinal product presents any particular
hazard to the dam or foetus. However, in pregnant sows and gilts a vulval discharge
which could be associated with abortion has been reported.
Use during pregnancy and lactation only according to the benefit-risk assessment by
the responsible veterinarian.
3.8 Interaction with other medicinal products and other forms of interaction
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.
Benzylpenicillin is bactericidal. Avoid concurrent use of bactericidal and bacteriostatic
antibiotics as they can antagonise the bactericidal effect of penicillins.
3.9 Administration routes and dosage
For Intramuscular use.
Dosage: 12 mg procaine benzylpenicillin (corresponding to 7 mg benzylpenicillin) per
kg bodyweight (equivalent to 2 ml of the veterinary medicinal product per 50 kg bw)
per day.
The treatment duration is 3 to 7 days.
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.
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The maximum volumes to be injected at any one site are 20 ml (Cattle), 3 ml (Pigs)
and 2 ml (Sheep).
The vials can only be broached a maximum of 30 times.
To ensure a correct dosage body weight should be determined as accurately as
possible.
Before use, shake the vial gently for a minimum of 10 seconds until all sediment is
readily dispersed.
3.10 Symptoms of overdose (and where applicable, emergency procedures and
antidotes)
Tolerance studies have been conducted at twice the recommended dosage rate in all
three target species without any ill-effects being observed.
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
Not applicable.
3.12 Withdrawal periods
Cattle:
Meat and offal: 10 days for treatment duration 3 days.
12 days for treatment duration 4-7 days.
Milk: 108 hours (4.5 days).
Pigs:
Meat and offal: 7 days for treatment duration 3 days.
9 days for treatment duration 4-7 days.
Sheep:
Meat and offal: 4 days for treatment duration 3 days.
6 days for treatment duration 4-7 days.
Not authorised for use in sheep producing milk for human consumption.
4.