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Date: Saturday, December 4, 2021 7:10

Description: MSD-AH
Release 2.178
Panacur® 187.5 mg/g Oral Paste for dogs and cats
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for dogs, Anthelmintics for cats
Active ingredient: Fenbendazole
Product:Panacur® 187.5 mg/g Oral Paste for dogs and cats
Product index: Panacur® 187.5 mg/g Oral Paste for dogs and cats
Withdrawal notes: Not applicable
Qualitative and quantitative composition
1 g of oral paste contains:
Active substance(s):
Fenbendazole 187.5 mg
Excipients:
Methyl hydroxybenzoate (E218) 0.17 mg
Propyl hydroxybenzoate 0.16 mg
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Oral Paste.
White to light grey, smooth, spreadable, homogeneous paste.
Clinical particulars
Target Species
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. 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.
Contraindications
None.
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 body weight or misadministration of the product.
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.
Wear impermeable rubber gloves while administering the product
Wash hands after use.
Adverse Reactions
None known.
Use during pregnancy or lactation
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.
Interactions
None known.
Amounts to be administered and administration route
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.
Adult Cats and Dogs
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.
Practical dosage recommendations:
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.
Puppies and kittens under 6 months of age
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.
Practical dosage recommendations:
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.
Pregnant dogs
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
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.
Increased dosing for specific infections
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.
Overdose
Benzimidazoles have a high margin of safety.
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.
Fenbendazole is metabolised to its sulphoxide, then to sulphone and amines.
Pharmacokinetic particulars
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 smaller extent in the urine and milk.
Pharmaceutical particulars
Excipients
Propyl hydroxybenzoate
Methyl hydroxybenzoate (E218)
Carbomer
Propylene glycol
Glycerol
Sorbitol
Sodium hydroxide
Water, purified.
Major incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Special precautions for storage
Do not store above 25°C.
Immediate packaging
White opaque, graduated syringe made of high density polyethylene, containing 4.8 g paste. The adjustable injector is sealed with a high density polyethylene cap.
Pack sizes: cardboard box with 1 syringe or 10 syringes.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product, or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 01708/4448
Significant changes
Date of the first authorisation or date of renewal
April 1998.
Date of revision of the text
September 2021.
Any other information
For animal treatment only. Keep out of the sight and reach of children. 
Legal category
Legal category: NFA-VPS
GTIN
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