Drontal Oral Suspension for Puppies Febantel 15 mg/ml / Pyrantel 5 mg/ml

Pyrantel 5.00 mg (as pyrantel embonate 14.40mg)
Excipients:
Qualitative composition of excipients
and other constituents
Quantitative composition if that
information is essentialfor proper
administration of the veterinary
medicinal product
Sodium benzoate (E211)2.05 mgSodium propionate (E281)2.05 mgPonceau 4R (E124)0.25 mgSodium dihydrogen phosphate dihydrateSorbitan oleate (E494)Povidone K25 (E1202)Polysorbate 80 (E433)Docusate sodiumBentonite (E558)Citric acid anhydrous (E330)Xanthan gum (E415)Propylene glycol (E1520)Purified water
Oral suspension.
Pale red suspension.
3. CLINICAL INFORMATION
3.1 Target species
Dogs (puppies and young dogs up to one year of age).
3.2 Indications for use for each target species
For the treatment of roundworm infections caused by:
Ascarids:
Toxascaris leonina
Hookworms: Ancylostoma caninum
Uncinaria stenocephala
Whipworm: Trichuris vulpis
3.3 Contraindications
Do not use simultaneously with compounds containing piperazine. See sections 3.7 and
3.8.
3.4 Special warnings
Parasite resistance to any particular class of anthelmintic may develop following frequent
repeated use of an anthelmintic of that class.
3.5 Special precautions for use
Special precautions for safe use in the target species:
The safety of the veterinary medicinal product has not been assessed in puppies
younger than 2 weeks and weighing less than 0.600 kg.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
Wash hands after use.
Avoid direct contact with the skin and eyes. In case of accidental spillage, wash the
affected area immediately with clean running water.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
Dogs:
Very rare
(<1 animal / 10 000 animals
treated, including isolated
reports):
Digestive tract disorder
(e.g. diarrhoea,
vomiting)
1
Mild and transient.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or the national competent authority via the
national reporting system. See the package leaflet for respective contact details.
3.7 Use during pregnancy, lactation or lay
Pregnancy and lactation:
Do not use in pregnant and lactating bitches.
3.8 Interaction with other medicinal products and other forms of interaction
The anthelmintic effects of both pyrantel (spastic paralysis) and piperazine
(neuromuscular paralysis) may be antagonised when the two drugs are used together.
3.9 Administration routes and dosage
Oral use.
Dosage and treatment schedule
For a single oral administration 15 mg/kg bodyweight febantel and 5 mg/kg bodyweight
pyrantel (as embonate) corresponding to 14.4 mg/kg pyrantel embonate, equivalent to 1
ml/kg bodyweight.
Through intrauterine and trans-mammary infection, ascarid infestation may occur in dogs
at a very early age. For some animals, especially in case of severe infections, elimination
of ascarids may be incomplete, and a potential risk of infections to humans cannot be
excluded. Where epidemiologically appropriate, it is recommended that treatment should
be started at 2 weeks of age and should be performed repeatedly at suitable intervals
(for example every 2 weeks), until weaning. Otherwise, treatment should be based upon
confirmed infection, for example the results of faecal examinations.
Method of administration
The veterinary medicinal product may be given directly to the animal or mixed with feed.
No special dietary measures are necessary.
Mix the veterinary medicinal product by inversion of the container before drawing the
required dose.
To ensure a correct dosage, body weight should be determined as accurately as
possible.
3.10 Symptoms of overdose (and where applicable, emergency procedures and
antidotes)
Doses of up to 5 times the therapeutic level of the veterinary medicinal product have
been administered to puppies and young dogs without clinical signs of intolerance
arising.
At 10 times the recommended dose the first sign of intolerance – vomiting – was evident.
3.11 Special restrictions for use and special conditions for use, including
restrictions on the use of antimicrobial and antiparasitic veterinary medicinal
products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Not applicable.
4.