CITRAMOX 1000MG/G 200GR

Citramox 1.000 mg/g powder for administration in drinking water for chickens, turkeys, ducks and pigs.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
Active substance:
Amoxicillin…………………………………………………………………………871,2mg
(equivalent to 1.000 mg amoxicillin trihydrate)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for administration in drinking water.
White powder. Clear, colorless liquid when in solution.
4. CLINICAL DATA
4.1 Target species
Chickens, turkeys, ducks and pigs.
4.2 Indications for use, specifying the target species
Treatment of infections caused by bacteria sensitive to amoxicillin in chickens, turkeys and
Ducks. Porcine: For the treatment of pasteurellosis.
4.3 Contraindications
This veterinary medicinal product must not be administered to horses or to rabbits, guinea pigs,
hamsters, gerbils or any other small herbivore.
Do not use in animals with known hypersensitivity to penicillins or other β-antibiotics.
lactams or any of the excipients.
Do not administer to animals with renal disease, including anuria or oliguria.
4.4 Special warnings for each target species
None.
4.5 Special precautions for use
Special precautions for use in animals
It is not effective against microorganisms that produce β-lactamases.
Spanish Agency of
Pigs: The intake of the veterinary medicinal product by animals may be altered in case of
of disease. In case the water consumption is insufficient, the animals must be
treated parenterally.
The use of the veterinary medicinal product must take into account official recommendations,
National and regional guidelines on the use of antimicrobials.
The use of the veterinary medicinal product should be based on susceptibility testing of the bacteria.
isolated from animals. If this is not possible, treatment should be based on the information
local (regional, farm level) epidemiological analysis of the susceptibility of the target bacteria.
The use of the veterinary medicinal product in conditions other than those recommended in the Sheet
technique may increase the prevalence of bacteria resistant to amoxicillin and may
decrease the effectiveness of treatment.
Special precautions to be taken by the person administering the medicinal product
vet to animals
Penicillins and cephalosporins can cause hypersensitivity (allergic) reactions.
after injection, inhalation, ingestion or skin contact. Hypersensitivity to
Penicillins can cross-react with cephalosporins and vice versa. In
Sometimes allergic reactions to these substances can be serious.
People with a known hypersensitivity to the active substance or if they have been warned not to
working with this type of preparations should avoid all contact with the medication
vet.
Handle the veterinary medicinal product with great care to avoid exposure, taking
all recommended precautions.
If symptoms appear after exposure, such as a skin rash, consult a doctor
immediately and show him the package insert or label. Swelling of the face, lips or eyes
or respiratory distress are more serious symptoms that require urgent medical attention.
Avoid inhaling dust. Wear a disposable mask in accordance with the European standard EN 149 or
a non-disposable mask conforming to the European standard EN 140 with an EN 143 filter.
Wear protective gloves during preparation and administration of the medicated water.
Wash exposed skin after handling veterinary medicinal product or medicated water.
Wash hands after use.
4.6 Adverse reactions (frequency and seriousness)
Penicillins and cephalosporins can cause hypersensitivity reactions that
occasionally they can be serious.
4.7 Use during pregnancy, lactation or lay
Laboratory studies in rats have not shown teratogenic effects.
due to the administration of amoxicillin.
Use only in accordance with the benefit/risk assessment performed by the veterinarian
responsible.
Do not use in laying birds whose eggs are used for human consumption and in the 3
weeks prior to the start of the laying period.
4.8 Interaction with other medicinal products and other forms of interaction
Do not administer with bacteriostatic antibiotics, such as tetracyclines, macrolides and sulfonamides.
Spanish Agency of
4.9 Amounts to be administered and administration route
Administration in drinking water.
Prepare the solution with fresh potable water immediately before use. any water
medication not consumed in the 24 hours following its preparation, it must be discarded and
should be replaced by another solution.
To ensure consumption of medicated water, animals should not have access to other
water sources while in treatment.
For the calculation of the required veterinary drug concentration, the
following formula (milligrams of veterinary medicine per liter of drinking water):

Medicated water should be the only source of drinking water during the period of
treatment.
To ensure the correct dose, the body weight of the animals should be determined as soon as possible.
exactly as possible and thus avoid underdosing. The consumption of medicated water depends
the clinical condition of the animals. In order to obtain a correct dosage the
Amoxicillin concentration should be adjusted taking into account water intake.
Chickens
The recommended dose is 15 mg amoxicillin trihydrate per kg body weight per day.
(equivalent to 15 mg of veterinary medicinal product/kg body weight/day).
The total period of treatment should be 3 days, or in severe cases, 5 days.
Pathos
The recommended dose is 20 mg amoxicillin trihydrate per kg body weight per day.
(equivalent to 20 mg veterinary medicinal product/kg body weight/day) for 3 days
in a row.
Turkeys
The recommended dose is 15-20 mg amoxicillin trihydrate per kg body weight per day.
(equivalent to 15-20 mg veterinary medicinal product/kg body weight/day) for 3 days, or in
severe cases, for 5 days.
Porcine
Administer in drinking water supplying 20 mg of amoxicillin trihydrate per kg of weight.
live (equivalent to 20 mg veterinary medicinal product/kg body weight) daily up to a
maximum 5 days.
Once the treatment period is over, the water dispensing system must be cleaned
adequately to avoid the ingestion of sub-therapeutic amounts of the active substance.
Spanish Agency of
The solubility in drinking water varies depending on the temperature and quality of the water. The
maximum solubility is approximately 1g/l at 4ºC in soft water but increases to 2g/l
20ºC in hard water.
For stock solutions and with the use of a dispenser, make sure not to exceed the solubility
maximum achievable under the given conditions. adjust the flow rate
dosing pump according to the concentration of the stock solution and water intake
of the treated animals.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No overdose problems have been described. Treatment should be symptomatic and not
There is no specific antidote available.
4.11 Waiting time(s)
Meat:

Its use is not authorized in laying birds whose eggs are used for consumption.
human. Do not use within 3 weeks from the start of laying.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: β-lactam antibiotics, penicillins.
ATCvet code: QJ01CA04
5.1 Pharmacodynamic properties
Amoxicillin is a bactericidal antibiotic with a time-dependent effect whose mechanism
of action is based on the inhibition of the synthesis of the bacterial cell wall during the
bacteria replication. Inhibits the formation of bridges between polymer chains
lines that make up the cell wall of peptidoglycans in gram-positive bacteria.
Amoxicillin is a broad-spectrum penicillin. It also acts against a limited number
of gram-negative bacteria in which the outer membrane of the bacterial cell wall is
Made up of lipopolysaccharides and proteins.
There are three main mechanisms of resistance to beta-lactam antibiotics:
production of beta-lactamases, an altered expression and/or modification of the proteins of
binding to penicillins (PBPs) and a reduced ability to penetrate the outer membrane. One
One of the most important is the inactivation of penicillin by the beta-lactamases that produce
some bacteria. These enzymes can break the beta-lactam ring of the
penicillins and thus inactivate them. Beta-lactamases can be encoded in both
the chromosome as by plasmids.
Cross-resistance has been observed between amoxicillin and other penicillins, especially those
aminopenicillins.
Spanish Agency of
The use of extended-spectrum beta-lactam antibiotics (eg, aminopenicillins) may
lead to the selection of multiresistant bacterial phenotypes (eg, the producers of
extended-spectrum beta-lactamases (ESBL)).
5.2 Pharmacokinetic data
Amoxicillin is well absorbed after oral administration and is resistant to gastric acids.
It is excreted unchanged mainly by the kidney to reach concentrations
higher in kidney tissue and urine. It is well distributed by body fluids.
Studies in birds indicate that amoxicillin is distributed and eliminated faster than in
mammals.
Biotransformation is a more important elimination route in birds than in mammals.
6. PHARMACEUTICAL DATA
6.1 List of excipients
Any.
6.2 Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed
with other veterinary drugs.
6.3 Validity period
Shelf-life of the veterinary medicinal product packaged for sale: 2 years
Shelf-life after first opening the immediate packaging: 3 months
Shelf-life after dissolution or reconstitution according to instructions: 24 hours
6.4. Special storage precautions
Keep bags tightly closed.
6.5 Nature and composition of immediate packaging
Heat-sealed bags formed by a complex of polyester, aluminum and polyethylene.
Formats:
200 bag g
500 bag g
Bag of 1 kg
20 x 200g bag
Not all formats may be marketed.

Spanish Agency of
Any unused veterinary medicinal product or residues derived from it must be
disposed of in accordance with local regulations.
7. MARKETING AUTHORIZATION HOLDER
LABORATORIES KARIZOO, SA
La Borda Mas Pujades Industrial Estate, 11-12
08140 – Caldes de Montbui (Barcelona)
Spain
8. MARKETING AUTHORIZATION NUMBER(S)
3452 ESP
9. DATE OF THE FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
Date of first authorization: July 26, 2016
10. DATE OF REVISION OF THE TEXT
PROHIBITION OF SALE, DISPENSATION AND/OR USE
Veterinary use. Medicinal product subject to veterinary prescription.
Administration under control or supervision of the veterinarian.
Spanish Agency of

See technical sheet