Apralan G200 Premix for Medicated Feeding Stuff

País: Regne Unit

Idioma: anglès

Font: VMD (Veterinary Medicines Directorate)

ingredients actius:

Apramycin

Disponible des:

Eli Lilly and Company Limited

Codi ATC:

amended)

Designació comuna internacional (DCI):

Apramycin

formulario farmacéutico:

Premix for medicated feeding stuff

tipo de receta:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapéutico:

Pigs

Área terapéutica:

Antimicrobial

Estat d'Autorització:

Authorized

Data d'autorització:

1998-04-06

Fitxa tècnica

Revised: March 2010
(ATCVet code amended)
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Apralan G200 Premix for medicated feeding stuff
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Apramycin (as apramycin sulphate) 200g apramycin per kg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Premix for medicated feeding stuff.
Light tan granular free flowing premix
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Apralan G200 Premix is indicated for use in young pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and control of bacterial enteritis in young pigs
caused by
_Escherichia coli_ and other apramycin sensitive organisms.
In vitro, the following organisms were susceptible to apramycin at
concentrations of 16 µg/ml or less:
i) Gram-positive bacteria
_Staphylococcus aureus._
ii) Gram-negative bacteria
_ Bordetella bronchiseptica_
_Escherichia coli_
_Campylobacter spp_
_Klebsiella spp_
_Salmonella spp_
_Proteus spp_
_Pseudomonas aeruginosa_
_Shigella sonnei_
iii) Mycoplasma
_ Mycoplasma hyopneumoniae_
Revised: March 2010
(ATCVet code amended)
4.3
CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to apramycin.
Do not use in cats.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i. Special precautions for use in animals
Official, national and regional antimicrobial policies should be taken
into account
when the product is used.
ii. Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
Avoid inhaling the powder while preparing the medicated feed.
Avoid contact with skin and eyes. In the event of skin contact, wash
thoroughly
with soap and water.
In the event of accidental eye contact, wash the affected eye with
fresh running
water and seek medical attention if irritation persists. Wash hands
after use.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Apralan G200 Premix is n