Drontal Oral Suspension for Puppies

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Febantel; Pyrantel embonate

Available from:

Vetoquinol SA

ATC code:

QP52AF02

INN (International Name):

Febantel; Pyrantel embonate

Dosage:

15 / 5 milligram(s)/millilitre

Pharmaceutical form:

Oral suspension

Prescription type:

CAM: Companion Animal Medicine as defined in relevant national legislation

Therapeutic area:

pyrantel

Authorization status:

Authorised

Authorization date:

2008-05-23

Summary of Product characteristics

Health Products Regulatory Authority
16 October 2020
CRN009Z8S
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Drontal Oral Suspension for Puppies
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES
Febantel
15.0
mg
Pyrantel
5.0
mg (as pyrantel embonate 14.4mg)
EXCIPIENTS:
Sodium benzoate (E211)
2.05
mg
Sodium propionate (E281)
2.05
mg
Ponceau 4R (E124)
0.25
mg
​
​
​
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral suspension.
Pale red suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs (puppies and young dogs up to one year of age)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of roundworm infections in puppies and young dogs up
to one year of age caused by:
Ascarids:
_Toxocara canis_
_Toxascaris leonina_
Hookworms:
_Ancylostoma caninum_
_Uncinaria stenocephala_
Whipworm:
_Trichuris vulpis_
4.3 CONTRAINDICATIONS
Do not use simultaneously with compounds containing piperazine. See
sections 4.7 and 4.8.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Parasite resistance to any particular class of anthelmintic may
develop following frequent repeated use of an anthelmintic of
that class.
Health Products Regulatory Authority
16 October 2020
CRN009Z8S
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The safety of the 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.
OTHER PRECAUTIONS
None
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
In very rare cases mild transient digestive tract signs (e.g.,
vomiting diarrhoea) may occur.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
Do not use in pregnant and lactating bitches.
4.8 INTERACTION WITH OTHER MEDICINAL P