Dogs, cats, puppies and kittens.

A broad spectrum anthelmintic for the treatment of domestic dogs and cats infected with immature and mature stages of nematodes of the gastro-intestinal and respiratory tracts. The product also has an ovicidal effect on nematode eggs.

Adult dogs and cats: For the treatment of adult dogs and cats infected with gastro-intestinal nematodes and cestodes:

Ascarid spp (Toxocara canis, Toxocara cati and Toxascaris leonina)

Ancylostoma spp

Trichuris spp

Uncinaria spp

Taenia spp

Puppies and kittens: For the treatment of puppies and kittens infected with gastro-intestinal nematodes and puppies infected with protozoa (Giardia spp).

Also for the treatment of dogs infected with lungworm Oslerus (Filaroides) osleri or protozoa Giardia spp and cats infected with lungworm Aelurostrongylus abstrusus.

None.

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 body weight or misadministration of the product.

Assess bodyweight as accurately as possible before calculating the dosage.

Direct contact with the skin should be kept to a minimum.

Wear impermeable rubber gloves while administering the product

Wash hands after use.

Mild gastrointestinal signs in dogs and in cats (such as vomiting and diarrhoea) can occur in very rare cases.

The frequency of these adverse reactions after the use of this product is based on post marketing safety experience (pharmacovigilance).

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

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

- 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).

Pregnant females may be safely treated with fenbendazole at therapeutic dosage levels. Owing to the reduced dose rate for treatment of pregnant dogs (25 mg fenbendazole/kg bodyweight daily) which cannot accurately be attained when using the syringe, it is recommended that alternative formulations of fenbendazole be used.

None known.

Should be administered orally by squeezing the paste from the syringe onto the back of the tongue after feeding.

Each injector contains 4.8 g paste, equivalent to 900 mg fenbendazole. To prepare the syringe for the first use, remove the syringe tip and turn the dial ring until the edge of the ring nearest the tip lines up with the zero (0) on the tube. Depress the plunger and discard any expelled paste.

To protect householders, discard any unused paste into tissue and immediately dispose of via the household waste.

The syringe is ready for use. The plunger has 18 graduations, each unit corresponding to 50 mg fenbendazole. Determine the number of graduations needed based on the body weight of the animal. Turn the ring on the plunger to the corresponding graduation.

Orally administer 2 syringe graduations per 1 kg bodyweight as a single dose (= 100 mg fenbendazole/kg bodyweight). Each syringe is sufficient to dose up to 9 kg bodyweight as a single dose.

Up to 1kg 2 syringe graduations

1.1 to 2 kg 4 syringe graduations

2.1 to 3 kg 6 syringe graduations

3.1 to 4 kg 8 syringe graduations

4.1 to 5 kg 10 syringe graduations

5.1 to 6 kg 12 syringe graduations

6.1 to 7 kg 14 syringe graduations

7.1 to 8 kg 16 syringe graduations

8.1 to 9 kg 18 syringe graduations

Additional syringes are required for dogs and cats weighing over 9 kg. For dogs and cats weighing over 9 kg, two extra syringe graduations are required for each additional 1 kg bodyweight as a single dose.

Treatment should be repeated when natural re-infection with parasitic worms occurs. Routine treatment of adult animals with minimal exposure to infection is advisable 2 to 4 times per year. More frequent treatment at 6 to 8 weekly intervals is advisable for dogs in kennels and cats in catteries or a breeder’s premises.

Only treat puppies and kittens weighing greater than 1 kg with this product.

Orally administer the recommended dosages as described below, daily for 3 consecutive days.

Each syringe is sufficient to dose up to 6 kg bodyweight for 3 consecutive days.

1.0 to 2 kg 2 syringe graduations daily for 3 days

2.1 to 3 kg 3 syringe graduations daily for 3 days

3.1 to 4 kg 4 syringe graduations daily for 3 days

4.1 to 5 kg 5 syringe graduations daily for 3 days

5.1 to 6 kg 6 syringe graduations daily for 3 days

Additional syringes are required if puppies weigh over 6 kg under 6 months old. For puppies weighing over 6 kg, an extra syringe graduation is required daily for each additional 1 kg bodyweight.

Puppies and kittens should be treated at 2 weeks of age, 5 weeks of age and again before leaving the breeder’s premises. Treatment may also be required at 8 and 12 weeks of age. Thereafter, frequency of treatment can be reduced unless the puppies and kittens remain in kennels or kittens remain in catteries/breeder’s premises where reinfection occurs more readily.

Owing to the reduced dose rate for treatment of pregnant dogs (25 mg fenbendazole/kg bodyweight daily) which cannot accurately be attained when using the syringe, it is recommended that alternative formulations of fenbendazole be used.

Pregnant cats can be safely treated with the product but only require a single treatment at the routine adult dose rate. Orally administer 2 syringe graduations per 1 kg bodyweight as a single dose (= 100 mg fenbendazole/kg bodyweight). Each syringe is sufficient to dose up to 9 kg bodyweight as a single dose.

For the treatment of clinical worm infestations in adult dogs and cats or Giardia spp. infections in dogs and puppies, orally administer 1 syringe graduation per 1 kg bodyweight daily for 3 consecutive days (= 50 mg fenbendazole/kg bodyweight daily for 3 days).

For the control of lungworm Oslerus (Filaroides) osleri in dogs administer 1 syringe graduation per 1 kg bodyweight for 7 consecutive days (= 50 mg fenbendazole/kg bodyweight daily for 7 days). A repeat course of treatment may be required in some cases.

Benzimidazoles have a high margin of safety.

Not applicable.