DRONTAL ORAL SUSPENSION FOR PUPPIES
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
FEBANTEL, PYRANTEL (AS EMBONATE)
Available from:
Bayer Limited
ATC code:
QP52AF02
INN (International Name):
FEBANTEL, PYRANTEL (AS EMBONATE)
Dosage:
1.50/1.44 %w/w
Pharmaceutical form:
Oral Suspension
Prescription type:
CAM-Companion Animal Medicine
Therapeutic group:
Canine
Therapeutic area:
Pyrantel
Therapeutic indications:
Endoparasiticide
Authorization status:
Authorised
Authorization date:
2008-05-23
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Drontal Oral Suspension for Puppies
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
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
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 23/08/2013_
_CRN 7013448_
_page number: 1_
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 SER
Read the complete document
