Censulfatrimsolution for injection

Sulfadiazine - trimethoprim
 
The names of the active ingredients and the other ingredients

Each ml contains:
The active ingredients:
Sulfadiazine 200.0 mg
Trimethoprim 40.0 mg
Inactive ingredients:
Sodium formaldehyde sulfoxylate 1.0 mg
Chlorocresol 1.0 mg
Other inactive ingredients (in sufficient quantity)
A clear, yellow, aqueous solution.
 
Labels:
For the treatment of systemic infections caused by or related to organisms sensitive to the combination between trimethoprim and sulfadiazine.
 
Contraindications:
Do not use if there is hypersensitivity to the active substances, to sulfonamides or to one or more of the inactive substances. Do not use for intra-abdominal administration. Do not use if there is severe liver or kidney damage or blood disorders.
 
Side Effects
Local side effects characterized by swelling and/or a lesion at the injection site may occur after the administration of the treatment. These effects naturally pass and disappear within one week of treatment.
Anaphylactic shock that may cause death has been observed in rare cases after the administration of strong sulfonamide solutions, especially when administered intravenously. At the first sign of intolerance, the injection should be stopped and treatment against the shock reaction should be started immediately.
In addition, disorders in the kidney and urinary tract (crystallization, blood in the urine and blockage of the kidney or urinary tract) and changes in hemoglobin function may occur.
The frequency of abnormal reactions is defined according to the following agreed distinction:
- High incidence (more than 1 animal out of 10 treated which exhibits abnormal reactions)
- Normal incidence (more than 1 animal but less than 10 animals out of 100 treated)
- low incidence (more than 1 animal but less than 10 animals out of 1,000 treated)
- Rarity (more than one animal but less than 10 animals out of 10,000 treated)
- Very rare (less than 1 animal out of 10000 animals treated, including individual reports).
If you notice any side effects, even those not listed in the package leaflet, or if you believe that the medicine did not work, inform the veterinary surgeon.
 
Target animals:
Cattle, pigs, horses, dogs and cats
Dosage for each of the target animals and method of administration:
Cattle, pigs and horses: 12.5 mg sulfadiazine + 2.5 mg trimethoprim / kg of body weight, equal to 1 ml of the veterinary medicinal product / 16 kg of body weight.
- Cattle and pigs: Administer by injection into the muscle or by slow injection into the vein. The maximum recommended volume to administer at one point into the muscle: 15 ml of the product.
- Horses: Administer by slow injection into the vein only.
Dogs and cats: 25 mg sulfadiazine + 5 mg trimethoprim / kg of body weight, equal to 1 ml of the veterinary medicinal product / 8 kg of body weight. To be administered by subcutaneous injection only.
In all animal species, one injection may be sufficient in uncomplicated cases. However, in cases where it is a serious infection, the treatment can be repeated up to two days from the disappearance of the symptoms and in general for five days at most.
 
Recommendation for administering the drug:
To ensure the correct dose, body weight must be determined as accurately as possible.
The cap can be safely punctured up to 30 times. The user must choose the most suitable vial size for the animal for which the treatment is intended.
 
waiting times:
Cattle: Meat: 12 days. Milk: 48 hours.
Pigs: meat: 20 days.
Horses: meat: 28 days.

Storage precautions:
Keep out of the reach of children. The vial should be kept in the outer carton to protect it from light. Do not freeze. Crystallization of the product may occur at low temperatures, and may be slightly heated to cause the crystals to melt. Do not use the veterinary medicinal product after the expiration date, which appears on the label after EXP. Shelf life after opening the bottle for the first time: 28 days.
 
Special warnings:
Special precautions for administration in animals: the product must be used based on the sensitivity test of the bacteria after their isolation from the animal. If this cannot be done, the treatment must be based on local epidemiological data (at the level of the regional farms) regarding the sensitivity of the bacteria for which the treatment is intended. Using the product in a manner inconsistent with the instructions on the product data sheet may increase the incidence of bacteria resistant to the product and reduce the effectiveness of treatment with other antimicrobial agents or other groups of antimicrobial agents because of possible cross-resistance. When using the product, the official policy, at a national or regional level, on antimicrobial substances must be taken into account. To prevent damage to the kidneys due to crystalluria during treatment, sufficient availability of drinking water must be ensured at all times.
Care should be taken when administering into the vein and choose this method of administration only if there is a therapeutic justification for it. If this mode of administration is chosen, the following
precautions must be taken:
- Cases of cardiac and respiratory shock have been observed so far in horses. At the appearance of the first sign of intolerance, the injection should be stopped and treatment against the shock reaction should be started.
- The veterinary medicinal product must be warmed to body temperature before administration.
- The veterinary medicinal product should be injected slowly over as long a period of time as is practically possible.
Special precautions to be taken by the person administering the veterinary medicinal product to the animals: People with known hypersensitivity to sulfonamides or trimethoprim should avoid contact with the veterinary medicinal product. The veterinary medicinal product must be administered carefully to avoid accidental self-injection and skin contact.
Use gloves when handling the veterinary medicinal product.
Wash hands after use.
If contact with skin or eyes occurs, wash immediately with plenty of water.
In case of accidental self-injection, seek medical help immediately and show the package leaflet or label to the doctor.
Pregnancy and breastfeeding: the veterinary medicinal product can be used during pregnancy and breastfeeding.
Interaction with other medicinal products and other forms of interaction: Do not give with para-amino benzoic acid (PABA) and its derivatives. Do not give with oral anticoagulants or substances that increase the level of acidity in the urinary tract. Administering strong sulfamides concurrently with alpha 2 adrenergic agents and certain anesthetic agents may cause cardiac arrhythmias in horses. Do not give to horses that exhibit heart rate irregularities following the administration of medication. Such irregularity in the heart rate may be related to the administration of certain anesthetics and anesthetics.
Overdose (symptoms, emergency procedures, antidote): crystalluria and neurological or blood disorders may occur. If an overdose has been given, stop the treatment and give the animal plenty of water and folic acid.
Incompatibility: In the absence of compatibility studies, this veterinary medicinal product should not be mixed with other veterinary medicinal products.
 
Marketed in 100 ml packages. 250 ml bottle.