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Date: Tuesday, April 16, 2024 0:20

Description: MSD-AH
Release 2.60
Panacur® Granules 222 mg/g
 
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for dogs, Anthelmintics for cats
Active ingredient: Fenbendazole
Product:Panacur® Granules 222 mg/g
Product index: Panacur® Granules 222 mg/g
Incorporating:
Qualitative and quantitative composition
Fenbendazole 222.22 mg/g
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Granules.
White or yellowish-white granular powder.
Clinical particulars
Target Species
Dogs, cats, puppies and kittens.
Indications for use
Dogs and cats
For the treatment of domestic dogs and cats infected with immature and mature stages of nematodes of the gastro-intestinal and respiratory tracts.
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, Toxascaris leonina)
Ancylostoma spp.
Trichuris spp.
Uncinaria spp.
Taenia spp.
Puppies and kittens: For the treatment of weaned puppies and kittens infected with gastro-intestinal nematodes and puppies infected with protozoa (Giardia spp):
Pregnant dogs: For the treatment of pregnant dogs to reduce prenatal infections with Toxocara canis and the transfer of T.canis and Ancylostoma caninum to their pups via the milk.
Also for the treatment of dogs infected with lungworm Oslerus (Filaroides) osleri or protozoa Giardia spp. and cats infected with lungworm Aelurostrongyles abstrusus.
Panacur also has an ovicidal effect on nematode eggs.
Contraindications
None.
Special warnings for each target species
None.
Special precautions for use
Assess bodyweight as accurately as possible before calculating the dosage.
Operator warnings
Direct contact with the skin should be kept to a minimum.
Avoid inhalation of granule dust. Wash hands after use.
Adverse Reactions
Gastrointestinal signs (such as vomiting and diarrhoea) can occur in very rare cases in dogs and cats.
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).
Use during pregnancy or lactation
Can be used during pregnancy in dogs and cats.
As teratogenic effects in dogs and cats cannot be completely ruled out in very rare cases, the treatment in the first two trimesters of pregnancy should be based on the benefit-risk evaluation by the responsible veterinarian.
Interactions
None Known.
Amounts to be administered and administration route
Oral use.
Routine treatment of adult dogs and cats
Administer 100 mg fenbendazole per 1 kg (2.2lb) bodyweight as a single dose.
Practical dosage recommendations:
1 g sachet /dose Treats 2 kg (4.4 lb) bodyweight as a single dose (1.1 – 2.2 kg)
1.8 g sachet / dose Treats 4 kg (8.8 lb) bodyweight as a single dose (2.2 – 4.4 kg)
4.5 g sachet /dose Treats 10 kg (22 lb) bodyweight as a single dose (5 – 10 kg)
For dogs weighing over 10 kg (22 lb), additional sachets are required according to the additional bodyweight.
Assess bodyweight as accurately as possible and then administer one or a combination of the above sachets, which most closely doses this bodyweight. The dose should be administered by mixing into the feed.
e.g. For a 9 kg dog = 2 kg dose (1 g sachet) + 4 kg dose (1.8 g sachet) + 4 kg dose (1.8 g sachet).
i.e. one x 1 gram sachet + two x 1.8 gm sachets. (10 kg dose)
or, one x 4.5 gram sachet (10 kg 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.
Weaned puppies and kittens under six months of age
Administer 50 mg fenbendazole per 1 kg (2.2 lb) bodyweight daily for 3 consecutive days.
Practical dosage recommendations:
1 g sachet /dose Treats 4 kg (8.8 lb) bodyweight (minimum weight 2.2 kg) dosed daily for three consecutive days (2.2 – 4.4 kg)
1.8 g sachet / dose Treats 8 kg (17.6 lb) bodyweight dosed daily for three consecutive days (4.5– 8 kg)
4.5 g sachet /dose Treats 20 kg (44 lb) bodyweight dosed daily for three consecutive days (10– 20 kg)
For dogs/puppies weighing over 20 kg (44 lb), additional sachets are required according to the additional bodyweight.
Assess bodyweight as accurately as possible and then administer one or a combination of the above sachets, which most closely doses this bodyweight. The dose should be administered by mixing into the feed.
e.g. For a 9 kg puppy = 4 kg dose (1 g sachet) + 8 kg dose (1.8 g sachet) daily for 3 consecutive days.
i.e. one x 1 gram sachet + one x 1.8 gram sachet (12 kg dose) daily for 3 days
or, three x 1 gram sachet (12 kg dose) daily for 3 days.
Puppies 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 pups remain in kennels where re-infestation occurs more readily.
Pregnant dogs
Administer 25 mg fenbendazole per 1 kg (2.2 lb) bodyweight daily from day 40 of pregnancy continuously to 2 days post-whelping (approximately 25 days).
Practical dosage recommendations:
1 g sachet /dose Treats 8 kg (17.6 lb) bodyweight daily approx. 25 days.
1.8 g sachet / dose Treats 16 kg (35.2 lb) bodyweight daily approx. 25 days.
4.5 g sachet /dose Treats 40 kg (88 lb) bodyweight daily approx. 25 days.
For bitches weighing over 40 kg, additional sachets are required according to the additional bodyweight.
Increased dosing for specific infections:
For the treatment of clinical worm infestations in adult dogs and cats or Giardia spp. infections in dogs, administer 50 mg fenbendazole per 1 kg (2.2 lb) bodyweight daily for 3 consecutive days.
For the control of lungworm Oslerus (Filaroides) osleri in dogs administer 50mg fenbendazole per 1 kg (2.2 lb) bodyweight, daily for 7 consecutive days.
A repeat course of treatment may be required in some cases.
For the control of lungworm Aelurostrongylus abstrusus in cats administer 50mg fenbendazole per 1 kg (2.2 lb) bodyweight daily for 3 consecutive days.
Overdose
Benzimidazoles have a high margin of safety. No specific overdose symptoms are known. No specific actions required.
Withdrawal periods
Not applicable.
Pharmacological particulars
ATC Vet Code QP52AC13
Pharmacotherapeutic group
Anthelmintics, benzimidazoles and related substances.
Pharmacodynamic properties
Fenbendazole is an anthelmintic belonging to the benzimidazole carbamates group. It acts by interfering in the energy metabolism of the nematode. The anthelmintic efficacy is based on inhibition of the polymerisation of tubulin to microtubuli. The anthelmintic affects both adult and immature stages of gastro-intestinal and respiratory nematodes.
Pharmacokinetic particulars
Fenbendazole is only partly absorbed from the intestine and reaches maximum plasma concentration in dogs 6 - 24 hours after oral administration. In cats the mean maximum serum concentration of fenbendazole was reached about 4 hours after treatment. Administration of fenbendazole in food did significantly increase its bioavailability compared to the administration on an empty stomach.
Fenbendazole is metabolised mainly by enzymes of the cytochrome P -450 system in the liver. The major oxidative metabolite is fenbendazole sulfoxide which is further metabolised to fenbendazole sulfone.
Fenbendazole and its metabolites are distributed throughout the body but highest concentrations are found in the liver.
The elimination half-life from plasma is about 15 hours after oral administration.
Fenbendazole and its metabolites are predominantly excreted via the faeces.
Pharmaceutical particulars
Excipients
Lactose monohydrate
Povidone 2500
Maize starch
Major incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 36 months.
Special precautions for storage
No special precautions for storage.
Immediate packaging
Pack sizes: 1g, 1.8g and 4.5g sachets.
Container: Low density polyethylene/aluminium foil/paper laminated sachet.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 01708/4427
Significant changes
Date of the first authorisation or date of renewal
23 January 1998
Date of revision of the text
March 2023
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: NFA-VPS
GTIN
GTIN description:Panacur Granules 22.2% 10x3x1.8g:
GTIN:05032984101140
GTIN description:Panacur Granules 22.2% 10x3x4.5g:
GTIN:05032984101164
GTIN description:Panacur Granules 22.2% 60x4.5g:
GTIN:05032984101195
GTIN description:Panacur Granules 22.2% 90x1.8g:
GTIN:05032984101188