Sulfatrim

1. NAME OF THE VETERINARY MEDICINAL PRODUCT
SULFATRIM, oral solution for chickens, turkeys and rabbits.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
1 ml of product contains:
Active substances:
Trimethoprim 40 mg
Sulfadimethoxine 200 mg
Excipients: up to 1.00 ml
For the complete list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Oral solution for administration in drinking water.

4. CLINICAL PARTICULARS
4.1. Species
Chickens, turkeys and rabbits.
4.2 Indications for use
Chickens: Respiratory and urogenital infections.
Turkeys: Respiratory and urogenital infections.
Rabbits: Respiratory and urogenital infections sustained by Gram+ positive and Gram- negative microorganisms sensitive to sulfonamides.
4.3 Contraindications

Do not administer for a long period of time.
Do not administer to animals sensitive to sulfonamides.
Do not administer to laying hens.
4.4. Special precautions
Use only after the sensitivity of the germs to the active principle has been determined. It is recommended to do an antibiogram before starting the treatment.
4.5 Special precautions for use
Special precautions for use in animals
Does not exist.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Avoid direct contact with the product while handling it.
4.6 Adverse reactions (frequency and severity) Some anaphylactic cases may occur in sensitive subjects.
4.7 Use during pregnancy, lactation or egg laying
Do not administer to animals that produce eggs for human consumption.

4.8 Interactions with other medicinal products or other forms of interactions
Does not exist.
4.9 Quantities to be administered and route of administration
Replace the residual water from watering cans with medicated water. Divide the daily dose into two equal parts and administer the treatment every 12 hours. It is recommended not to administer water before starting the treatment, in order to make the animals thirsty.
Chickens: in drinking water 10.0 – 20.0 g/100 kg live weight (equivalent to 2.0 - 4.0 g sulfadimethoxine + 0.4 – 0.8 g trimethoprim/100 kg g.w.), or 0.5-1L per 1000L water depending on age, weight and the birds' water consumption, for 5-6 consecutive days.
Turkeys: in drinking water 10.0 – 20.0 g/100 kg body weight (equivalent to 2.0 - 4.0 g of sulfadimethoxine + 0.4 – 0.8 g trimethoprim/100 kg body weight) depending on the age, weight and water consumption of the birds, for 5-6 consecutive days.
Rabbits: in drinking water 10.0 - 20.0 g/100 kg of body weight (equivalent to 2.0 - 4.0 g of sulfadimethoxine + 0.4 - 0.8 g of trimethoprim/100 kg of body weight) depending on the age, weight and water consumption of the animals, time for 5-6 consecutive days.
4.10. DOSAGE
There are no data available.
4.11 Waiting time
Chicks: 8 days.
Turkeys: 7 days.
Rabbits: 11 days.
Do not administer to laying hens that produce eggs for human consumption.
5. PHARMACOLOGICAL PROPERTIES
ATC Veterinary Code - QJ01EW10
Pharmacotherapeutic group: sulfonamides and trimethoprim
5.1 Pharmacodynamic properties
The product is a combination of sulfadimethoxine and trimethoprim. The action mechanism, which is a synergism of the two components, is based on and consists of a sequential block of folic acid synthesis. In fact, the basic active nucleus, which is a common element for all sulfonamides, is "sulfonylamide", a structure that by replacing (PABA), the para-aminobenzoic acid structure is incorporated by germs and prevents a combination of PABA itself with alcohol 2 -amino-4-hydroxy-7,8-dihydroxy-pteridine-6-methyl, as claimed by the precursor molecule of folic acid. Folic acid and its derivatives, folinic acid (citrovorum factor) are growth factors involved in the metabolism of purines and pyrimidines (components of DNA and RNA) and in the metabolism of amino acids (protein biosynthesis). Trimethoprim develops its antibacterial action by blocking the metabolism of folic acid during the transformation of dehydrofolic acid into tetrahydrofolic acid by inhibiting the enzyme dehydro-folate-reductase, which takes part in this process. Then, the spectrum of action of the drug includes Escherichiacoli, Sighella spp., Haemophilus Spp., Salmonella Spp., Pasteurella Spp., infections with staphylococci, streptococci and actinobacilli, Rickettsiae and some protozoa, including Toxoplasma and Coccidians.

5.2. Features
The active substance of the medicine, when administered orally, is quickly absorbed (especially sulfadimethoxine) and is distributed in all tissues. Sulfadimethoxine is acetylated mainly in the liver, and the unmodified parts are often eliminated by the kidneys, part of trimethoprim is metabolized (its metabolism is still unknown) and quickly eliminated in unmodified and metabolized form. Its biological classifications are
with a duration between 1.5 and 3.5 hours, while with sulfadimethoxine they are between 3 and 10 hours.
6. Pharmaceutical particularities
6.1. List of excipients:

Sodium hydroxide
polyethylene
Purified water
6.2 Incompatibilities
Does not exist.
6.3 Validity Period
Validity of the veterinary medicinal product as packaged for sale: 24 months
Product validity after the first opening of the primary packaging: 30 days.
Product validity after dilution in water: 12 hours
6.4 Special precautions for storage
Protected from the sun's rays.
6.5. The nature and composition of the primary packaging
- Bottles of 100 ml 1 liter.
- 5 liter cans.
6.6. Special precautions for disposal of unused or expired veterinary medicinal product
Dispose in accordance with regional and national regulations in force.
7. MARKETING AUTHORIZATION HOLDER
Chemifarma S.p.A.