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

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktívna zložka:

Febantel, Pyrantel

Dostupné z:

Bayer Animal Health GmbH

ATC kód:

QP52AF02

INN (Medzinárodný Name):

Febantel, Pyrantel

Forma lieku:

Oral suspension

Typ predpisu:

NFA-VPS - Non-Food Animal – Veterinarian, Pharmacist, Suitably Qualified Person

Terapeutické skupiny:

Dogs

Terapeutické oblasti:

Anthelmintic

Stav Autorizácia:

Authorized

Dátum Autorizácia:

1998-04-17

Súhrn charakteristických

Revised: June 2020
AN: 00182/2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
MEMBER STATE
PROPOSED NAME
AT
Drontal Junior
DE
Welpan für Welpen und junge Hunde
EE
Drontal Puppy
FI
Welpan vet
FR
Dronstop Chiot
ES
Drontal suspensión oral para cachorros y perros
jóvenes
IE
Drontal Oral Suspension for Puppies
IS
Welpan vet
LT
Drontal Puppy
LV
Drontal Puppy
NO
Welpan vet
UK
Drontal Oral Suspension for Puppies
Febantel 15 mg/ml / Pyrantel 5 mg/ml
Oral Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH ML CONTAINS
ACTIVE SUBSTANCES:
Febantel
15.00mg
Pyrantel
5.00mg (as pyrantel embonate 14.40mg)
EXCIPIENTS:
Sodium benzoate (E211)
2.05mg
Sodium propionate (E281) 2.05mg
Ponceau 4R (E124)
0.25mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension
Pale red suspension
Page 1 of 6
Revised: June 2020
AN: 00182/2020
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
Parasite resistance to any particular class of anthelmintic may
develop following frequent
repeated use of an anthelmintic of that class.
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