Flimabo 100 mg/g Suspension for Use in Drinking Water for Chickens and Pigs

국가: 영국

언어: 영어

출처: VMD (Veterinary Medicines Directorate)

유효 성분:

Flubendazole

제공처:

Krka d.d., Novo Mesto

ATC 코드:

QP52AC12

INN (International Name):

Flubendazole

약제 형태:

Oral suspension

처방전 유형:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

치료 그룹:

Chickens, Pigs

치료 영역:

Anthelmintic

승인 상태:

Authorized

승인 날짜:

2013-07-18

제품 특성 요약

Revised: November 2017
AN: 00620/2017
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
FLIMABO 100 mg/g suspension for use in drinking water for chickens and
pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
ACTIVE SUBSTANCE:
Flubendazole
100 mg
EXCIPIENTS:
Methyl parahydroxybenzoate (E218)
2.0 mg
Sodium benzoate (E211)
5.0 mg
Disodium edetate
0.1 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for use in drinking water.
White to brownish white suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (piglets, pigs for fattening, pregnant and lactating sows) and
chickens (layer hens,
chickens for reproduction, pullets, broilers).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In hens/chickens:
Treatment of helminthiasis caused by _Ascaridia galli_ (adult stages),
_Heterakis gallinarum _
(adult stages), _Capillaria _spp. (adult stages).
In pigs:
Treatment of helminthiasis caused by _Ascaris suum_ (adult and
intestinal larval stages) in
piglets, fattening pigs, pregnant and lactating sows.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
In chickens, optimal results can only be achieved if strict rules of
hygiene are respected
in the maintenance of the cages.
Revised: November 2017
AN: 00620/2017
Page 2 of 7
In both 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,
misadministration
of the product, or lack of calibration of the dosing device (if any).
Suspected clinical cases of resistance to anthelmintics should be
further investigated
using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where
t