Armitage Worm Away 100mg Film-coated Tablets for Dogs

Composition

Each tablet contains

Active substances:

Nitroscanate 100 mg

Excipient(s):

Titanium Dioxide (E171) 0.0.778 mg

Ferric Oxide Yellow (E172) 0.0257 mg

Ferric Oxide Black (E172) 0.00003 mg

Ferric Oxide Red (E172) 0.00003 mg

As constituents of Opadry OY-GM 7900

For the full list of excipients, see section 6.1.

6.1 List of excipients

Opadry-Oy_Gm 7900 Consisting of:

Titanium Dioxide (E171)

Ferric Oxide Yellow (E172)

Ferric Oxide Black (E172)

Ferric Oxide Red (E172)

Maize Starch

Cellulose, Microcrystalline

Sodium Starch Glycolate

Sodium Laurilsulfate

Magnesium Stearate

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Pharmaceutical form

Film-coated tablets.

Round convex tablets, yellow coloured, film coated.

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Pharmacological properties

Pharmacotherapeutic group: Anthelmintic, Other anthelmintic agents, nitroscanate

ATCvet code: QP52AX01

5.1 Pharmacodynamic Properties

The mode of action of nitroscanate has not been well established. However, there is some evidence that nitroscanate decreases the ATP/ADP ratio affecting energy producing pathways within the target parasites. This leads to the death of the parasite. The concentration of unabsorbed nitroscanate in contact with the helminths appears to be more important for efficacy than absorption into the blood.

5.2 Pharmacokinetic Properties

Pharmacokinetic data from dogs are not available. In other species (mice and sheep), the drug is only partly absorbed from the gastrointestinal tract when administered orally, with the majority of the dose being eliminated in the faeces. The remainder of the dose is metabolised and excreted in the urine.

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Target species

Dogs

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Indications

Treatment of the following cestodes (tapeworms) and intestinal nematodes (roundworms):

Nematodes:

Ascarids: Toxocara canis (adult parasite stage),

Hookworms: Ancylostoma caninum (adult parasite stage)

Cestodes

Taenia species (T. hydatigena, T. pisiformis, T. ovis) (adult and immature parasite stages) and Dipylidium caninum (adult parasite stage).

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Dosage

The dose of the product is 50 mg nitroscanate/kg bodyweight, which is equivalent to 1 x 100 mg tablet per 2 kg (4.4 lb) bodyweight.

The product should be administered together with about one-fifth of the daily food ration in the morning when the dog’s stomach is empty. The remaining food ration should be administered in the evening. The tablets should be given whole.

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Contraindications

Do not administer to dogs that are sick or recovering from an illness.

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

Do not use in dogs weighing less than 2 kg.

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Adverse reactions

In rare cases, digestive tract disorders (hypersalivation, vomiting, diarrhoea, blood in vomit or diarrhoea) have been reported. Do not repeat treatment if vomiting occurs shortly after dosing. Treat symptomatically.

Neurological disorders (convulsions/epileptic seizures, ataxia, muscle tremors and collapse) may occur in very rare cases.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reactions)

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

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Warnings

i. Special precautions for use in animals

The product should not be administered to puppies less than 6 months old, owing to the need to restrict food intake at the time of administration. See also section 4.9.

If a hypersensitivity reaction occurs treatment should be discontinued.

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

Tablets are film-coated and should not be broken or divided to avoid skin and eye irritation.

This product may cause hypersensitivity (allergy). Avoid contact with this product if you know you are sensitised.

Accidental ingestion may cause gastro-intestinal disturbances. If symptoms persist, seek medical advice and show the package leaflet or the label to the physician.

Wash hands after use.

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Use during pregnancy, lactation or lay

The product can be safely used during pregnancy and lactation.

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Interactions

None known

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Overdose

See section 4.6. Adverse events are more likely to occur if the product is overdosed.

In a target species tolerance study, elevated levels of alanine transferase (ALT), amylase and alkaline phosphatase (ALKP) enzymes, indicative of liver dyscrasia, were observed in dogs administered the product at 5-8 times the recommended dose.

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Special warnings

Since the most common tapeworm of the dog (Dipylidium caninum) is transmitted by a flea and has a very short pre-patent period, it is important to pay attention to flea control to reduce the incidence of tapeworm in the animal. The advice of a veterinary surgeon, pharmacist or Suitably Qualified Person (SQP) should be sought regarding the need for and frequency of repeat treatment.

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Withdrawal period

Not applicable

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Incompatibilities

None known

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Immediate packaging

Aluminium foil, low density polyethylene strips in outer carton containing

1 x 4 tablets

1 x 6 tablets

1 x 100 tablets

Not all pack sizes may be marketed.

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Storage

Store in a dry place.

Do not store above 25°C

Keep blister strip in outer carton

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 5 years.

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Disposal of unused product

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

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Additional information

Vm 08749/4074

9 DATE OF FIRST AUTHORISATION

22 March 2019

10 DATE OF REVISION OF THE TEXT

September 2023

Approved: 21 September 2023

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Registration holder

Chanelle pharmaceuticals Manufacturing Ltd

Loughrea

Co. Galway

Ireland

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