NOAH Compendium

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Date: Tuesday, August 11, 2020 5:57

Description: MSD-AH
Release 2.32
Panacur® Small Animal 10 % Oral Suspension
 
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for dogs, Anthelmintics for cats
Active ingredient: Fenbendazole
Product:Panacur® Small Animal 10 % Oral Suspension
Product index: Panacur® Small Animal 10 % Oral Suspension
Qualitative and quantitative composition
Active substance % w/v
Fenbendazole: 10.000
 
Other substances
Sodium methyl hydroxybenzoate: 0.200
Sodium propyl hydroxybenzoate: 0.020
 
Benzyl alcohol: 0.4835
For full list of excipients, see section "Pharmaceutical Particulars".
Pharmaceutical form
A white oral suspension.
Clinical particulars
Target species
Domestic dogs, cats, puppies and kittens.
Indications for use
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.
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 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 domestic dogs infected with lungworm Oslerus (Filaroides) osleri or protozoa Giardia spp., and cats infected with lungworm Aelurostrongylus abstrusus.
Also has an ovicidal effect on nematode eggs.
Contraindications
None known.
Special warnings for each target species
None.
Special precautions for use
Assess body weight as accurately as possible before calculating the dosage.
Operator warnings
Direct contact with the skin should be kept to a minimum.
Wear impermeable rubber gloves and wash hands after use.
Other
The use of this product should be based on local epidemiological information about susceptibility of the nematodes and recommendations on how to limit further selection for resistance to anthelmintics.
Adverse reactions
Gastrointestinal signs (such as vomiting and diarrhoea) can occur in very rare cases in the dogs and cats.
The frequency of adverse reaction is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
Use during pregnancy, lactation or lay
The product can be used in pregnant bitches. 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 veterinary surgeon.
Interactions
None known.
Amounts to be administered and administration route
Shake the container before use.
Routine treatment of adult cats and dogs
1 ml per 1 kg body weight as a single oral dose (= 100 mg fenbendazole/kg body weight).
Practical dosage recommendations:
2 to 4 kg
4 ml
4 to 8 kg
8 ml
8 to 16 kg
16 ml
16 to 24 kg
24 ml
24 to 32 kg
32 ml
32 to 64 kg
64 ml
For dogs weighing over 64 kg, an extra 1 ml is required for each additional 1 kg body weight.
The dose should be mixed with feed, or administered orally directly after feeding.
Treatment should be repeated when natural reinfestation 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.
Puppies and kittens under six months of age
0.5 ml per kg body weight daily for 3 consecutive days given by mouth after feeding to unweaned animals or mixed with food for weaned animals (= 50 mg fenbendazole/kg body weight daily for 3 days).
Practical dosage recommendations:
Up to 1 kg
0.5 ml daily for 3 days
1 to 2 kg
1 ml daily for 3 days
2 to 4 kg
2 ml daily for 3 days
4 to 6 kg
3 ml daily for 3 days
6 to 8 kg
4 ml daily for 3 days
8 to 10 kg
5 ml daily for 3 days
For puppies weighing over 10 kg, an extra 0.5 ml is required daily for each additional kg body weight.
Puppies should be treated at 2 weeks of age, 5 weeks of age and again before leaving the breeders' 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 reinfestation occurs more readily.
Pregnant dogs
1 ml per 4 kg body weight daily from day 40 of pregnancy continuously to 2 days post-whelping (approximately 25 days) (= 25 mg fenbendazole/kg body weight daily).
Practical dosage recommendations:
4 kg
1 ml daily for approx. 25 days
8 kg
2 ml daily for approx. 25 days
12 kg
3 ml daily for approx. 25 days
20 kg
5 ml daily for approx. 25 days
40 kg
10 ml daily for approx. 25 days
For dogs weighing over 40 kg, an extra 1 ml is required daily for each additional 4 kg body weight.
As treatment of pregnant dogs is 98% effective, puppies from these dogs should themselves be treated with a three day course at 2 and 5 weeks of age.
Pregnant cats
Pregnant cats can be safely treated with this product but only require a single treatment at the routine adult dose rate. Administer 1 ml per 1 kg body weight as a single dose (=100 mg fenbendazole/kg body weight).
Increased dosing for specific infections
For the treatment of clinical worm infestations in adult dogs and cats or Giardia spp. infections in dogs administer 1 ml per 2 kg body weight daily for 3 consecutive days (= 50 mg fenbendazole/kg body weight daily for 3 days).
For the control of lungworm Oslerus (Filaroides) osleri in dogs administer 1 ml per 2 kg bod yweight daily for 7 consecutive days (= 50 mg fenbendazole/kg body weight daily for 7 days).
A repeat course of treatment may be required in some cases.
For the control of lungworm Aelurostrongylus abstrusus in cats administer 1 ml per 2 kg body weight daily for 3 consecutive days (= 50 mg fenbendazole/kg body weight daily for 3 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
Pharmacodynamic properties
ATC Vet Code: QP52AC13
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 properties
Fenbendazole is only partly absorbed after oral administration and is then metabolised in the liver. Fenbendazole and its metabolites are distributed throughout the body and high concentrations can be found in the liver. The elimination of fenbendazole and its metabolites occurs primarily via the faeces (>90%) and to a small extent in the urine and milk.
 
Fenbendazole is metabolised to its sulphoxide, then to sulphone and amines.
Pharmaceutical particulars
Excipients
Sodium methyl hydroxybenzoate, Sodium propyl hydroxybenzoate, Benzyl alcohol, Silica colloidal, Carmellose sodium, Povidone, Sodium citrate dehydrate, Citric Acid and Water purified.
Major incompatibilities
None known.
Shelf life
2 years.
Special precautions for storage
Do not freeze.
Immediate packaging
Multidose container of 100 ml. Container: Opaque white high density polyethylene. Closure: Foil seal with polyethylene screw cap.
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 Number
Vm 01708/4436
Significant changes
Date of the first authorisation or date of renewal
29 January 2003.
Date of revision of the text
March 2020
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 10% SU 10x100ml:
GTIN:05032984102017