Tramazole 2.5% w/v SC Oral Suspension for Cattle and Sheep

Composition

Active Substance: % w/v

Albendazole 2.5

Excipients:

Oral suspension.

A pale blue aqueous suspension.

3

Pharmacological properties

4.1 ATC Vet Code: QP52AC11

4.2 Pharmacodynamics

Benzimidazoles bind to nematode tubulin, a protein necessary for the formation and viability of microtubules. This occurs primarily in absorptive intestinal cells resulting in the absence of microtubules in the intestinal cells of the nematode, with the result that these cells cannot absorb nutrients, thus causing a consequent reduction in glycogen and effective starvation of the parasites. Structural differences have been shown to exist between tubulin from mammalian and helminth sources, resulting in the preferential toxicity of albendazole to the helminth and not to the host. Benzimidazoles have also been shown to inhibit the fumarate reductase system of helminths and impair energy production.

4.3 Pharmacokinetics

The veterinary medicinal product is a broad spectrum multi-purpose anthelmintic for the control of mature and developing immature forms of gastrointestinal roundworms, lungworms, tapeworms and adult liver fluke in cattle and sheep. The product is also ovicidal against fluke and roundworm eggs.

3

Target species

Cattle and sheep.

3

Indications

The veterinary medicinal product is a broad spectrum multi-purpose anthelmintic for the control of mature and developing immature forms of gastrointestinal roundworms, lungworms, tapeworms and adult liver fluke in cattle and sheep. The product is also ovicidal against fluke and roundworm eggs.

In cattle the product is active against the following species:

Roundworms: Ostertagia, Haemonchus, Trichostrongylus, Nematodirus, Oesophagostomum, Bunostomum, Cooperia and Strongyloides spp. It is usually effective against inhibited larvae of Cooperia and Ostertagia, Lungworms: Dictyocaulus viviparus, Tapeworms: Moniezia spp., Adult liver fluke: Fasciola hepatica

In sheep, the veterinary medicinal product is active against benzimidazole- susceptible strains of the following species:

Roundworms: Ostertagia, Haemonchus, Trichostrongylus, Nematodirus, (including N. battus), Chabertia and Oesophagostomum. It is usually effective against inhibited larvae of Ostertagia.

Lungworms: Dictyocaulus filaria, Tapeworms: Moniezia spp., Adult liver fluke: Fasciola hepatica

The veterinary medicinal product is ovicidal and will kill fluke and roundworm eggs, thus reducing pasture contamination.

3

Dosage

For oral administration only using properly calibrated dosing equipment. To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked. One ml contains 25mg albendazole. Shake the container before use.

Cattle:

Worm dose: For the control of roundworms, lungworms, tapeworms and fluke and roundworm eggs, Dosage: 7.5 mg albendazole per kg bodyweight.

Fluke and Worm Dose: For the additional treatment of adult liver fluke (chronic fascioliasis) in cattle.

Dosage: 10 mg albendazole per kg bodyweight.

Sheep:

Worm Dose: For the control of roundworms, lungworms, tapeworms and fluke and roundworm eggs, Dosage: 5 mg albendazole per kg bodyweight.

Fluke and Worm Dose: For the additional treatment of adult liver fluke (chronic fascioliasis) in sheep.

Dosage: 7.5 mg albendazole per kg bodyweight.

Cattle over 300 kg: administer a further 15 or 20 ml for each additional 50 kg bodyweight.

Sheep over 60 kg: administer a further 2 or 3 ml for each additional 10 kg bodyweight.

3

Contraindications

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

3

Adverse reactions

None known.

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 holder or the national competent authority via the national reporting system.

See the package leaflet for respective contact details.

3

Warnings

Special precautions for safe use in the target species:

Care must be taken not to damage the pharyngeal region when dosing, particularly in sheep. Not to be diluted or mixed with other products. Avoid the introduction of contamination during use. Intensive use or misuse of anthelmintics can give rise to resistance. To reduce this risk dosing programmes should be discussed with your veterinary surgeon. The product should only be used in areas where Cobalt and Selenium deficiencies are known to occur. If in doubt, consult a veterinary surgeon.

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

Avoid direct contact with the veterinary medicinal product.

Personal protective equipment consisting of impermeable gloves should be worn when handling the veterinary medicinal product.

In the event of accidental eye exposure, flush eye thoroughly with running water. If irritation persists, seek medical advice and show the package leaflet or the label to the physician.

In the event of accidental skin exposure, wash the affected area with soap and

water. If irritation persists, seek medical advice and show the package leaflet or the label to the physician.

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.

3

Use during pregnancy, lactation or lay

Pregnancy and lactation:

Do not dose ewes at the “fluke and worm” dose rate, (7.5 mg/kg) during tupping or for 1 month after removing the rams.

Can be safely used during lactation. The use in breeding bulls or pregnant cattle is not expected to interfere with their reproductive performance.

3

Interactions

interaction

Do not administer other cobalt and selenium supplements concurrently with this product unless specifically advised by your veterinary surgeon.

3

Overdose

No effects at recommended usage. Treatment is symptomatic.

3

Special warnings

Cattle suffering from severe lung damage due to heavy lungworm infestation may continue to cough for some weeks after infection.

Selenium bioavailability is enhanced in lambs receiving ionophores, so concurrent treatment will increase the risk of toxicity.

Care should be taken to avoid the following practices because they increase

the risk of development of resistance and could ultimately result in ineffective therapy:

• Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.

• Underdosing, which may be due to underestimation of bodyweight, misadministration of the product, or lack of calibration of the dosing device (if any).

Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

Resistance to benzimidazoles (which includes albendazole) has been reported in Teladorsagia, Haemonchus, Cooperia and Trichostrongylus species in small ruminants in a number of countries, including the EU. Resistance to albendazole has been reported in Cooperia and Teladorsagia species in cattle in developed countries such as New Zealand. Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.

3

Withdrawal period

Cattle:

Meat and offal: 14 days.

Milk: 60 hours.

Sheep:

Meat and offal: 4 days.

Do not use in sheep producing milk for human consumption.

3

Incompatibilities

None known.

3

Immediate packaging

1, 2.5, 5 and 10 litre high density polyethylene jerricans with polypropylene closure (screw-fit) with polyethylene faced steran wads.

1, 2.5, 5 and 10 litre high density polyethylene flexi containers with high density polyethylene closures (screw-fit) with expanded polyethylene liners.

Not all pack sizes may be marketed.

3

Storage

No special precautions for storage.

3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

3

Disposal of unused product

Medicines should not be disposed of via wastewater.

Do not contaminate ponds, waterways or ditches with the product or used containers.

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.

3

Additional information

Vm 11810/4007

8 DATE OF FIRST AUTHORISATION

23 August 1996

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

July 2026

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.

Approved: 13 August 2026

3

Registration holder

Tulivin Laboratories Ltd

3