ΠΑΡΑΡΤΗΜΑ 1: ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BACOLAM powder for oral solution for calves, sheep, goats, swine, foals, chickens, turkeys
(excluding layers).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g contains:
Active substances
amoxicillin (as amoxicillin sodium)..............................100 mg
colistin sulphate......................................................500,000 I.U.
Excipients: q.s. to..............................................................1 g
For a complete list of the excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral solution.
4.
CLINICAL PARTICULARS
4.1.
Target species
Calves, sheep, goats, swine, foals, chickens, turkeys (excluding layers).
4.2.
Indications for use, specifying the target species
BACOLAM powder for oral solution is indicated in calves, sheep, goats, swine, foals,
chickens and turkeys in the treatment of infections to the gastrointestinal, bronchopulmonary,
urinary and cutaneous systems, due to microorganisms sensitive to the amoxicillin-colistin
combination. More specifically: Gram-positive bacteria (amongst which Actinomyces spp,
Bacillus anthracis, Clostridium spp, Corynebacterium spp, Erysipelothrix rhusiopathiae,
Listeria monocytogenes, Staphylococcus spp and Streptococcus spp), Gram-negative bacteria
(amongst which Actinobacillus spp, Bordetella bronchiseptica, Enterobacter aerogenes,
Escherichia coli, Fusobacterium spp, Haemophilus spp, Klebsiella pneumoniae, Moraxella
spp, Ornithobacterium rhinotracheale, Pasteurella spp, Proteus mirabilis, Pseudomonas
aeruginosa, Salmonella spp and Shigella spp.,) and Leptospira spp.
4.3.
Contraindications
Do not use in animals with known hypersensitivity to amoxicillin or to colistin.
Do not administer to polygastric animals with a functioning rumen, to rabbits or to small rodents.
Do not administer to subjects with renal insufficiency as nephrotoxicity and neurotoxicity could
occur.
4.4.
Special warnings for each target species
Do not treat ruminants with a functioning rumen.
4.5.
Special precautions for use
Special precautions for use in animals
The product must be used on the basis of the results of antibiogram tests. If this should not be
possible, therapy should be established on the basis of local epidemiological information
(regional or from the breeding establishment) on the sensitivity of the target bacteria.
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Use of the product other than according to the instructions supplied may lead to an
increase in the incidence of bacteria resistant to amoxicillin or colistin and reduce
the efficacy of treatments with other antibacterial agents, owing to the possible
appearance of cross-resistance.
Do not exceed the recommended dosage.
Special precautions to be taken by the person administering the veterinary
medicinal product to the animals
People with known hypersensitivity to the active substances must avoid contact
with the veterinary medicinal product.
Carefully mix with the drinking water or the liquid feed. Do not mix with solid
feed.
Properly clean the mixing tools. During mixing operations, direct contact with the
product must be avoided. For this purpose, operators must wear gloves and a mask
and must also wash their hands carefully after preparing the product. In case of
accidental skin or eye contamination, wash carefully with soap and water. Do not
swallow; in case of accidental ingestion, see a doctor immediately and show the
package leaflet or the label.
4.6.
Adverse reactions (frequency and seriousness)
In rare cases allergic reactions are possible.
Prolonged use of the product may produce phenomena of intestinal dysmicrobism,
with digestive disorders such as nausea, vomiting and diarrhoea, and may favour the
development of insensitive microorganisms.
4.7.
Use during pregnancy, lactation or lay
Use only according to a risk/benefit assessment by the attending veterinarian. Use
is not permitted in animals producing milk or eggs for human consumption.
4.8.
Interaction with other medicinal products and other forms of interaction
The action of the two antibiotics may be antagonised by the concurrent administration
of antibiotics with bacteriostatic activity.
Avoid combination with other drugs or other nephrotoxic antibiotics
(aminoglycosides).
4.9.
Amounts to be administered and administration route
Calves, sheep, goats, swine, foals:
Chickens, turkeys:
10 g/100 kg b.w. per day (equivalent to 10
mg/kg b.w. of amoxicillin and 50,000 I.U./kg
b.w. of colistin sulphate per day) for 3-5 days.
0.1 – 0.15 g/kg b.w. per day (equivalent to 10
– 15 mg/kg b.w. of amoxicillin and 50,000 75,000 I.U./kg b.w. of colistin sulphate per
day) for 3-5 days.
Administer the dose subdivided into two administrations each day, dissolved in
drinking water or in milk.
Administration in the drinking water must be performed taking into account the
daily consumption of water and the body weight, so as to administer the prescribed
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dose. Consumption of medicated water or milk depends on the clinical state of
health of the animals. To ensure the correct dosage and to avoid over- or
underdosing, group the animals to be treated on the basis of body weight, taking
into account the daily water consumption and carefully calculate the dosage of
product to be solubilised in drinking water or in milk.
4.10. Overdose (symptoms, emergency procedures, antidotes), if necessary
No symptoms due to overdose are known.
Do not exceed the recommended doses.
4.11. Withdrawal periods
Meats and offal
Calves, sheep, goats, swine, foals:
Broiler chickens and turkeys:
28 days.
2 days.
Use is not permitted in animals producing milk or eggs for human consumption.
5.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: association of antibacterial agents
ATC Vet Code: QJ01RA01
5.1.
Pharmacodynamic properties
BACOLAM is a preparation based on two antibiotics, amoxicillin and colistin.
Amoxicillin, a semisynthetic penicillin active against Gram-positive and Gramnegative bacteria, acts by inhibition of synthesis of the bacterial cell wall.
Colistin, a cyclic polypeptide antibiotic similar to the polymyxins, is selectively
active against Gram-negative microorganisms and acts by disorganising the cell
membrane with leakage of intracellular materials.
The amoxicillin-colistin combination is active against Gram-positive bacteria
(amongst which Actinomyces spp, Bacillus anthracis, Clostridium spp,
Corynebacterium spp, Erysipelothrix rhusiopathiae, Listeria monocytogenes,
Staphylococcus spp and Streptococcus spp), Gram-negative bacteria (amongst
which Actinobacillus spp, Bordetella bronchiseptica, Enterobacter aerogenes,
Escherichia coli, Fusobacterium spp, Haemophilus spp, Klebsiella pneumoniae,
Moraxella spp, Ornithobacterium rhinotracheale, Pasteurella spp, Proteus
mirabilis, Pseudomonas aeruginosa, Salmonella spp and Shigella spp.) and
Leptospira spp.
5.2.
Pharmacokinetic particulars
Amoxicillin is stable in an acidic environment and shows gastroenteric absorption
higher than 80% of the dose administered; by the parenteral route, absorption is
rapid and complete. Approximately 15% of the quantity present in the blood binds
to plasma proteins. It distributes widely and rapidly, permitting blood and tissue
concentrations to be obtained which are higher than the mean MICs. It shows a
high pulmonary tropism, reaching a concentration in bronchial mucus which is
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twice the blood concentration; bacterial lysis is much more rapid than that obtained
with ampicillin. It shows no toxicity. It is eliminated in active form particularly by
the urinary route.
Colistin, stable in an acidic environment (pH between 3 and 6), following oral
administration in the form of the sulphate, is not absorbed from the gastroenteric
tract, exerting only a local antibacterial action and thus permitting a targeted
therapy at the gastrointestinal tract level, where infections are normally due to
Gram-negative microorganisms.
When administered by the parenteral route, colistin is rapidly absorbed and
distributes easily, reaching tissue levels which are higher and more persistent than
those in the blood.
The colistin-amoxicillin association for oral use shows additional effect and
permits, owing to the different pharmacokinetics of the active substances, two
types of therapy to be produced at the same time: a specific therapy in the
gastrointestinal tract by colistin (which is not absorbed enterically) and systemic
therapy, in particular of the respiratory, urinary and integumentary systems, due to
amoxicillin (which is absorbed enterically).
6.
PHARMACEUTICAL PARTICULARS
6.1.
List of excipients
Anhydrous glucose.
6.2.
Incompatibilities
In the absence of compatibility studies, do not mix with other veterinary medicinal
products.
6.3. Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf-life after first opening the immediate packaging: 2 months.
Shelf-life after dilution according to directions: 12 hours.
6.4.
Special precautions for storage
Store in a cool, dry place, protected from light and at a temperature not exceeding
25°C.
6.5.
Nature and composition of immediate packaging
1000 g high-density polyethylene jar with undercap, closed with a lid with a tearoff safety seal.
5 kg and 10 kg heat-sealed bags, in a polyester, aluminium and polyethylene
multilayer.
6.6.
Special precautions for the disposal of unused veterinary medicinal product or
waste materials derived from the use of such products
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Any unused veterinary medicinal product or waste materials derived from such
medicinal products should be disposed of in accordance with local requirements.
7.
MARKETING AUTHORISATION HOLDER
FATRO S.p.A. - Via Emilia, 285 - Ozzano dell'Emilia - Bologna - Italy.
8.
MARKETING AUTHORISATION NUMBERS
19059
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 1/11/2000
Date of renewal: 8/4/2013
10.
DATE OF REVISION OF THE TEXT
8/4/2013
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
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