Amphen, 200 mg/g Granules for Use in Drinking Water for Pigs

Country: Միացյալ Թագավորություն

language: անգլերեն

source: VMD (Veterinary Medicines Directorate)

active_ingredient:

Florfenicol

MAH:

Huvepharma N.V.

ATC_code:

QJ01BA90

INN:

Florfenicol

pharmaceutical_form:

Granules for use in drinking water

prescription_type:

POM-V - Prescription Only Medicine – Veterinarian

therapeutic_group:

Pigs

therapeutic_area:

Antimicrobial

authorization_status:

Expired

authorization_date:

2013-06-24

SPC

Revised July 2018
AN: 01612/2017
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
AMPHEN, 200 mg/g granules for use in drinking water for pigs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
ACTIVE SUBSTANCE:
Florfenicol
200.0 mg
EXCIPIENT(S):
Butylhydroxytoluene (E321)
1.0 mg
Disodium edetate
1.0 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Granules for use in drinking water.
White to cream waxy granules.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of swine respiratory disease associated with
_Pasteurella multocida_
susceptible to florfenicol.
4.3
CONTRAINDICATIONS
Do not administer to boars intended for breeding purposes.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Do not use in piglets less than 6 weeks old.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
If there is no significant improvement after 3 days of treatment, the
diagnosis should be
reviewed and if necessary the treatment should be changed_._
In case of insufficient water intake, animals should be treated
parenterally
Revised July 2018
AN: 01612/2017
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
Use of the product should be based on susceptibility testing of the
bacteria isolated from
the animal. It this not possible, therapy should be based on local
(regional, farm level)
epidemiological information about susceptibility of the target
bacteria.
Official and local antimicrobial policies should be taken into account
when the product is
used.
Use of the product deviating from the instructions given in the SPC
may increase the
prevalence of bacteria resistant to florfenicol and may decrease the
effectiveness of
treatment with amphenicols due to the potential for cross-resistance.
Treatment should not exceed 5 days.
ii)
Special precautions for the person administering the veterinary
medicinal
product to animal