CITRAMOX 500 MG/G POWDER 1 KG | AMOXICILLIN

CITRAMOX 500 MG/G POWDER FOR ADMINISTRATION IN DRINKING WATER FOR CHICKENS, TURKEYS, DUCKS AND PIGS

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
Active substance:
Amoxicillin (equivalent to 500 mg of amoxicillin trihydrate) …………….436 mg
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 rabbits, guinea pigs, hamsters, gerbils or any other small herbivores.
Do not use in animals with known hypersensitivity to penicillins or other β-lactam antibiotics or to 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.
Pigs: The intake of the veterinary medicinal product by animals may be altered in case of illness. In case the water consumption is insufficient, the animals should be treated parenterally.
The use of the veterinary medicinal product should take into account official, national and regional recommendations on the use of antimicrobials.
The use of the veterinary medicinal product should be based on susceptibility testing of the bacterium isolated from animals. If this is not possible, treatment should be based on local (regional, farm level) epidemiological information on 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 veterinary medicinal product to animals
Penicillins and cephalosporins may cause hypersensitivity (allergic) reactions upon injection, inhalation, ingestion, or skin contact. Hypersensitivity to penicillins can lead to cross-reactions with cephalosporins and vice versa. Sometimes allergic reactions to these substances can be severe.
People with known hypersensitivity to the active substance or who have been advised not to work with such preparations should avoid all contact with the veterinary medicinal product.
Handle the veterinary medicinal product very carefully to avoid exposure, taking all recommended precautions.
If symptoms such as a rash appear after exposure, seek medical advice immediately and show the package leaflet or label. Swelling of the face, lips or eyes or respiratory distress are more serious symptoms that require urgent medical attention.
Avoid inhaling dust. Use a disposable mask in accordance with the European standard EN 149 or a non-disposable mask in accordance with the European standard EN 140 with an EN 143 filter.
Wear protective gloves during preparation and administration of medicated drinking water or liquid food.
Wash exposed skin after handling the veterinary medicinal product, medicated water or
I think. 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 birds during lay and in the 3 weeks prior to the start of the laying period.
put.
4.8 Interaction with other medicinal products and other forms of interaction
Do not administer with bacteriostatic antibiotics, such as tetracyclines, macrolides and sulfonamides.
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 12 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):

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 30 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 40 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 30-40 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 40 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.
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 from the group of semisynthetic penicillins with a
spectrum of action against Gram-positive and Gram-negative bacteria. Its activity is based on
inhibition of bacterial cell wall synthesis by interfering with the synthesis of
peptidoglycans.
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
anhydrous citric acid
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: 21 months
Shelf-life after first opening the immediate packaging: 3 months
Shelf-life after dissolution or reconstitution according to instructions: 12 hours
6.4. Special storage precautions
Do not store at temperatures above 30°C.
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:
400 bag g
Bag of 1 kg
Not all formats may be marketed.
6.6 Special precautions for disposal of the veterinary medicinal product not
used or, where appropriate, the residues derived from its use
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 Industrial Estate
More Bids, 11-12
08140 – CALDES DE MONTBUI (Barcelona)
Spain
8. MARKETING AUTHORIZATION NUMBER(S)
3088 ESP
9. DATE OF THE FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
01 September 2014
10. DATE OF REVISION OF THE TEXT
PROHIBITION OF SALE, DISPENSATION AND/OR USE
Veterinary use – Medicine subject to veterinary prescription.
Administration under control or supervision of the veterinarian

See technical sheet