Censutrim 200 mg/ml + 40 mg/ml Solution for Injection for Cattle, Pigs, Horses, Dogs and Cats

Composition

Each ml contains:

Active substances:

Sulfadiazine 200 mg

Trimethoprim 40 mg

Excipients:

A clear, yellow aqueous solution free from visible particles.

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Pharmacological properties

4.1 ATCvet code: QJ01EW10

4.2 Pharmacodynamics

Sulfadiazine (SDZ) inhibits the incorporation of para-aminobenzoic acid into folic acid and trimethoprim (TMP) inhibits the enzyme dihydrofolate reductase (DHFR) which converts dihydrofolic acid into tetrahydrofolic acid. TMP and SDZ act together synergistically with a double-blockade mode of action. The combination is bactericidal, inhibiting sequential steps in the synthesis of purines which are required for DNA synthesis. TMP/SDZ combinations have a broad bactericidal action against many Gram-positive and Gram-negative aerobic bacteria and a large proportion of anaerobic bacteria.

Bacterial resistance to trimethoprim and to sulphonamides may appear. It is mediated by the following 5 main mechanisms: (1) the permeability barrier and/or efflux pumps, (2) naturally insensitive target enzymes, (3) regulational changes in the target enzymes, (4) mutational or recombinational changes in the target enzymes, and (5) acquired resistance by drug-resistant target enzymes.

4.3 Pharmacokinetics

Both active substances of the combination are rapidly absorbed after parenteral administration and distributed throughout the body.

Sulfadiazine is protein bound only to a limited extent and is well distributed. Metabolism occurs in the liver and the major products are acetylated derivatives which are excreted mainly by glomerular filtration. The plasma half lives in cattle, pigs and dogs are 2 - 3 and 4 hours respectively. The half-life when given to horses in combination with Trimethoprim is 3 hours.

Trimethoprim is a weak base with low water solubility. Trimethoprim is about 65% protein bound but, being lipid soluble, readily penetrates cellular barriers to become widely distributed. It is partly oxidised and conjugated in the liver and the metabolites, plus unchanged Trimethoprim are excreted in the urine. The degree of metabolism varies: 80% in the dog and almost 100% in the cow. The half-life is also variable: 4 hours in the horse, 2 hours in the pig and 1 hour in the cow. Given the wide interspecies variability in the half-life of both actives, it is not possible to attain pharmacokinetic matching of the two compounds, but there is evidence that synergism occurs over a wide range of dose ratios. The combination of 1:5 trimethoprim:sulfadiazine is well documented for veterinary use.

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Target species

Cattle, pigs, horses, dogs and cats.

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Indications

The product is indicated in the treatment of systemic infections caused by or associated with organisms susceptible to the Trimethoprim: Sulfadiazine combination.

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Dosage

Intramuscular, intravenous or subcutaneous route.

Cattle, pigs and horses: 12.5 mg of sulfadiazine + 2.5 mg of trimethoprim / kg bodyweight, equivalent to 1 ml of veterinary medicinal product / 16 kg bodyweight.

- Cattle and pigs: administer by intramuscular or slow intravenous injection, once daily until 2 days after symptoms resolve up to a maximum of 5 days. Maximum recommended volume to be administered at a single intramuscular site: 15 ml of product.

- Horses: administration is by slow intravenous injection only, once daily until 2 days after symptoms resolve up to a maximum of 5 days.

Dogs and cats: 25 mg of sulfadiazine + 5 mg of trimethoprim / kg bodyweight, equivalent to 1 ml of veterinary medicinal product / 8 kg bodyweight. Administration is by subcutaneous injection only, once daily until 2 days after symptoms resolve up to a maximum of 5 days.

To ensure a correct dosage, bodyweight should be determined as accurately as possible.

The cap may be safely punctured up to 40 times using a 20-gauge needle or up to 20 times using a 16-gauge needle. The user should choose the most appropriate vial size according to the target species to be treated.

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Contraindications

Do not use in cases of hypersensitivity to the active substances, to sulphonamides or to any of the excipients.

Do not use in case of severe liver or kidney damage or blood dyscrasias.

Do not use in case of reduced water intake or losses of body fluid.

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Adverse reactions

Cattle, pigs, horses, dogs and cats:

1 Particularly after the intravenous route (see section 3.5). At the first sign of intolerance the injection should be interrupted and shock treatment initiated.

2 These lesions are of a transient nature, resolving within one week after treatment.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product.

Reports should be sent, preferably via a veterinarian, to either the marketing authorisation or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Use of the product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at farm level, or at local/regional level.

Use of the product should be in accordance with official, national and regional antimicrobial policies.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the product and may decrease the effectiveness of treatment with other antimicrobials or classes of antimicrobials, due to the potential for cross-resistance.

Cross-resistance has been shown between sulfonamides. Use of the veterinary medicinal product should be carefully considered when susceptibility testing has shown resistance to sulfonamides because its effectiveness may be reduced.

In order to avoid impairment of the kidneys by crystalluria during the treatment adequate drinking water should be available at all times.

The intravenous route should be used with caution and only if it is therapeutically justified. If this administration route is used, the following precautions will be taken into account:

- Cardiac and respiratory shock in horses has been observed. At the first sign of intolerance the injection should be interrupted and shock treatment initiated.

- The veterinary medicinal product should be warmed to body temperature before administration.

- The veterinary medicinal product should be injected slowly over as long period as is reasonably practical.

The feeding of waste milk containing residues of trimethoprim-sulfadiazine to calves should be avoided up to the end of the milk withdrawal period (except during the colostral phase), because it could select antimicrobial-resistant bacteria within the intestinal microbiota of the calf and increase the faecal shedding of these bacteria.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

• This product may cause an allergic reaction in people sensitised to sulfonamides and/or chlorocresol. Hypersensitivity to sulfonamides may lead to cross reactions with other antibiotics. Allergic reactions to these substances may occasionally be serious. People with known hypersensitivity to sulfonamides or chlorocresol should avoid contact with the product.

• Administer the product with caution to avoid accidental self injection and skin contact. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

• This product may cause eye and skin irritation. Avoid the contact with skin and eyes. In case of contact with skin or eyes, rinse immediately with plenty of water. If irritation persists, seek medical attention.

• If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the physician this warning. Swelling of the face, lips or eyes, or difficulty with breathing are more serious symptoms and require urgent medical attention.

• Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Women of childbearing age, pregnant women or women suspected of being pregnant should use the veterinary medicinal product with serious caution to avoid accidental self-injection.

• Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable

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Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established in cattle, pigs, horses, dogs and cats during pregnancy, lactation or in animals intended for breeding.

Laboratory studies with the excipient N-methyl pyrrolidone have shown evidence of foetal malformations in rabbits and rats. Use only according to the benefit-risk assessment by the responsible veterinarian.

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Interactions

Do not administer with para-aminobenzoic (PABA) acid and its derivatives.

Local anaesthetics from the group of para-aminobenzoic acid esters (procaine, tetracaine) can locally inhibit the effect of sulfonamides.

Do not administer with oral anticoagulants or urinary acidifiers.

Administration of potentiated sulphonamides, simultaneously with alpha-2-adrenergic agents and certain anaesthetics, may cause cardiac arrhythmias in horses.

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Overdose

Crystalluria and nerve and hematic disorders may occur.

In case of overdose, suspend the treatment and administer abundant water and folic acid.

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Special warnings

None.

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Withdrawal period

Cattle:

Meat and offal: 12 days

Milk: 48 hours

Pigs:

Meat and offal: 20 days

Horses:

Not to be used for horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation.

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Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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Immediate packaging

Amber glass vials, with bromobutyl stopper and aluminum cap with FLIP-OFF seal.

Pack sizes:

Cardboard box with 1 vial of 100 ml

Cardboard box with 1 vial of 250 ml

Cardboard box with 10 vials of 100 ml

Cardboard box with 10 vials of 250 ml

Not all pack sizes may be marketed.

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Storage

Do not freeze.

Crystallisation of the product, which can occur at low temperatures, can be reversed by gentle warming.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: 28 days.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 61058/5001

8 DATE OF FIRST AUTHORISATION

25 November 2024

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

December 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Gavin Hall Approved: 18 December 2025

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Registration holder

Duggan Veterinary Supplies Limited

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