Alphafluben 44 mg/ml Oral Gel for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Flubendazole

Available from:

Alpha-Vet Allatgyogyaszati Kft.

ATC code:

QP52AC12

INN (International Name):

Flubendazole

Pharmaceutical form:

Oral gel

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Anthelmintic

Authorization status:

Authorized

Authorization date:

2022-02-07

Summary of Product characteristics

Issued: February 2022
AN: 00104/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Alphafluben 44 mg/ml oral gel for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Flubendazole:
44 mg
EXCIPIENTS:
Methyl parahydroxybenzoate (E218)
1.8 mg
Propyl parahydroxybenzoate
0.2 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral gel
White or almost white, odourless suspension gel
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Anthelmintic for the treatment of dogs infected with roundworms,
hookworms and
whipworms.
Roundworms: _Toxocara canis, Toxascaris leonina_
Hookworms:_ Ancylostoma caninum_
Whipworms: _Trichuris vulpis_
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance(s) or
to any of the
excipient(s).
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Care should be taken to avoid the following practices because they
increase the risk
of development of resistance and could ultimately result in
ineffective therapy:
•Too frequent and repeated use of anthelmintics from the same class,
over an
extended period of time.
•Underdosing,
which
may
be
due
to
underestimation
of
body
weight
or
misadministration of the product.
Issued: February 2022
AN: 00104/2020
Page 2 of 6
The decision to use the product should be based on confirmation of the
parasitic
species and burden, or of the risk of infection based on its
epidemiological features,
for each individual animal
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Parasite resistance may develop to a particular class of anthelmintics
after frequent
and repeated administration of that anthelmintic class.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
This veterinary medicinal product may cause allergic reactions. People
with known
hypersensitivity to flubendazole or to the excipients methyl
parahydroxybenzo