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

Negara: Inggris

Bahasa: Inggris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Febantel, Pyrantel

Tersedia dari:

Bayer Animal Health GmbH

Kode ATC:

QP52AF02

INN (Nama Internasional):

Febantel, Pyrantel

Bentuk farmasi:

Oral suspension

Jenis Resep:

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

Kelompok Terapi:

Dogs

Area terapi:

Anthelmintic

Status otorisasi:

Authorized

Tanggal Otorisasi:

1998-04-17

Karakteristik produk

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