SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Tribamec Duo 50 mg/ml & 1 mg/ml Oral Suspension for Sheep

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients:

Triclabendazole 50 mg/ml Ivermectin 1 mg/ml

Excipients:

Methyl parahydroxybenzoate (E218) 1.2 mg/ml

Propyl parahydroxybenzoate 0.5 mg/ml

Benzyl alcohol 27.0 mg/ml

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension

Cream coloured aqueous oral suspension.

4. CLINICAL PARTICULARS

4.1 Target Species

For sheep over 3 months of age.

4.2 Indication for use

Treatment of mixed trematode (fluke) and nematode or arthropod infections due to gastrointestinal roundworms, lungworms, liver fluke and nasal bots.

Gastrointestinal nematodes (adult and immature):

Haemonchus contortus, Teladorsagia (Ostertagia) circumcincta, Trichostrongylus spp, Cooperia spp, Nematodirus spp including N. battus, Strongyloides papillosus, Oesophagostomum spp, and adult Chabertia ovina.

Inhibited larval stages and benzimidazole resistant strains of Haemonchus contortus and Teladorsagia (Ostertagia) circumcincta are also controlled.

Liver fluke (mature, immature and early immature stages down to less than 1 week of age): Fasciola hepatica

Lungworms (adult and immature):

Dictyocaulus filaria

Nasal bots (all stages): Oestrus ovis

4.3 Contraindications

Do not use in animals with known hypersensitivity to the active ingredients or any of the excipients.

4.4 Special warnings for each target species

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, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

Resistance to ivermectin has been reported in Teladorsagia (Ostertagia) circumcincta and Haemonchus contortus and increasing resistance to triclabendazole has been reported in Fasciola species in sheep in a number of countries including in Europe. Therefore, the use of this product should be based upon local (regional, farm) epidemiological information about susceptibility of the target parasites and recommendations on how to limit further selection for resistance to anthelmintics.

4.5 Special precautions for use

i. Special precautions for use in animals

Extra-label use in dogs should be avoided as severe adverse reactions may occur. In common with other avermectins, certain breeds of dogs, such as Collies are especially sensitive to ivermectin and particular care should be taken to avoid accidental consumption of the product.

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

• People with known hypersensitivity to active substances or parabens should avoid contact with the product.

• This product may cause skin and eye irritation.

• Avoid direct contact with the skin and eyes.

• Protective gloves should be worn when handling the product.

• In case of accidental spillage onto skin or into the eyes wash immediately with water. Take off any contaminated clothes.

• Do not eat, drink or smoke whilst handling the product.

• Wash hands and any exposed skin before meals and after work.

iii. Other precautions

Ivermectin is highly toxic to aquatic organisms, and ivermectin and triclabendazole are highly toxic to dung flies and beetles. Long-term effects on dung insects caused by continuous or repeated use cannot be excluded.

The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of this product and other products of the same anthelmintic class in cattle, sheep and pigs. Therefore, the repetition of treatment in a pasture during a season should be performed only in the absence of alternative treatment and on veterinary advice.

4.6 Adverse reactions

None known.

4.7 Use during pregnancy and lactation

The safety of this combination of active ingredients has not been shown during pregnancy or lactation or in animals intended for breeding. No alteration of lactation has been reported for ivermectin and triclabendazole when used as monotherapy in sheep. Therefore it should be used in pregnant/lactating animals only according to a risk:benefit analysis by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

No data available.

4.9 Amount(s) to be administered and administration route

For oral use.

The dose rate is 0.2 mg ivermectin and 10 mg triclabendazole per kg bodyweight equivalent to 2 ml/10 kg bodyweight.

Bodyweight should be assessed accurately before calculating the dose. The product is for oral administration using a suitably calibrated dosing gun. The container should be shaken thoroughly before use. Drenching equipment should be cleaned before and after use.

If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under- or overdosing.

The timing for treatment should be based on epidemiological factors and should be customised for each individual farm. As with other anthelmintics, veterinary advice should be sought on appropriate dosing programmes and stock management to achieve adequate parasite control and reduce the likelihood of resistance developing.

Dosing Table:

Animal Weight	Dose of the product
20 – 25 kg	5 ml
26 – 30 kg	6 ml
31 – 35 kg	7 ml
36 – 40 kg	8 ml
41 – 50 kg	10 ml
51 – 60 kg	12 ml
61 – 70 kg	14 ml
71 – 80 kg	16 ml
81 – 90 kg	18 ml
91 – 100 kg	20 ml

4.10 Overdose

No clinical signs were observed after overdosing 5 times. At 10 times overdosing liver and kidney function may be affected slightly. There is no antidote.

4.11 Withdrawal period

Meat and offal: 27 days.

Not authorised for use in ewes producing milk for human consumption including during the dry period. Do not use within 1 year prior to the first lambing in ewes intended to produce milk for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Ivermectin is an endectocidal macrocyclic lactone.

Triclabendazole is an anthelmintic benzimidazole.

ATCvet Code: QP54AA51

5.1 Pharmacodynamic properties

Avermectins interact with glutamate-gated chloride ion channels, to increase membrane permeability to chloride ions, causing irreversible neuromuscular blockade in nematodes and arthropods, followed by paralysis and death.

Triclabendazole interferes with intracellular transport mechanisms and inhibits protein synthesis and is active against the liver fluke Fasciola.

5.2 Pharmacokinetic properties

Ivermectin is readily absorbed and reaches peak plasma concentrations within 1 day. Afterwards plasma concentrations decrease with a half life of up to 5 days.

Triclabendazole is readily absorbed, oxidised to triclabendazole sulfoxide and to triclabendazole sulfone. Peak plasma concentrations are reached within 2 days. Afterwards plasma concentrations decrease with a half life of about 1.5 days. Both metabolites bind strongly to plasma proteins, particularly albumin. More than 90 % of the dose is excreted in the feces, about 2 % in the urine and less than 1 % in the milk within 10 days.

The inter-individual variability of the kinetics of ivermectin and metabolites of triclabendazole in ovine species is high.

6. PHARMACEUTICAL PARTICULARS

6.1 List of Excipients

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate

Benzyl Alcohol

Microcrystalline cellulose and Carmellose sodium

Povidone

Propylene glycol

Polysorbate 20

Simethicone Emulsion

Sodium Dihydrogen Phosphate Monohydrate

Disodium Phosphate Dihydrate Purified water

6.2 Major incompatibilities

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

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life after first opening the immediate packaging: 1 year.

6.4 Special precautions for storage

Do not store above 30ºC

Store in the original container in order to protect from light.

Protect from frost.

6.5 Nature and composition of immediate packaging

The product is available in the following containers:

1L, 2.5L, 3L & 5L: Container and Closure: White HDPE flexi containers with a

Polypropylene cap and an aluminium foil seal.

10 L: Container and Closure: High Density Polyethylene (HDPE) white container with a HDPE cap and an aluminium foil seal. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. Dangerous to fish and other aquatic life. Do not contaminate ponds, waterways or ditches with the product or used container.

7. MARKETING AUTHORISATION HOLDER

EU Pharmaceuticals Ltd

37 Geraldine Road

London

SW18 2NR

8. MARKETING AUTHORISATION NUMBER

Vm 39787/4134

9. DATE OF FIRST AUTHORISATION

16 November 2021

10. DATE OF REVISION OF THE TEXT

November 2021

PROHIBITION OF SALE, SUPPLY AND/OR USE

To be supplied only on veterinary prescription.

Approved 16 November 2021