Neoiven 500 000 IU/g Powder for Use in Drinking Water/Milk Replacer

国: イギリス

言語: 英語

ソース: VMD (Veterinary Medicines Directorate)

即購入

ダウンロード 製品の特徴 (SPC)
05-05-2023

有効成分:

Neomycin

から入手可能:

Laboratorios e Industrias IVEN S.A.

ATCコード:

QA07AA01

INN(国際名):

Neomycin

医薬品形態:

Powder for use in drinking water/milk

処方タイプ:

POM-V - Prescription Only Medicine – Veterinarian

治療群:

Cattle, Chickens, Duck, Goose, Partridge, Pigs, Quail, Turkeys

治療領域:

Antimicrobial

認証ステータス:

Authorized

承認日:

2018-07-11

製品の特徴

                                Unlimited renewal: May 2023
AN: 00156/2023
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NEOIVEN 500 000 IU/g powder for use in drinking water/milk replacer
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
ACTIVE SUBSTANCE:
Neomycin (as neomycin sulphate)500 000 IU
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for use in drinking water/milk replacer.
White or almost white powder.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (calves), pigs (weaned and fattening pigs), chickens, layer
hen, ducks, turkeys,
turkey hen, goose, quail and partridge.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment of gastrointestinal infections caused by _E. coli_
sensitive to neomycin.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance, to
aminoglycosides or
to the excipients or in the presence of intestinal obstruction.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Medicated drinking water intake can be affected by the severity of the
disease. In
case of insufficient intake of water, animals should be treated
parenterally.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Powder for oral solution that is to be dissolved in water and cannot
be used as it is.
Special care should be taken when considering to administer the
product to the
newborn calf due to the known higher gastrointestinal absorption of
neomycin in
neonates.
This
higher
absorption
could
lead
to
an
increased
risk
of
oto-
and
nephrotoxicity.
The
use
of
the
product
in
neonates
should
be
based
on
the
benefit/risk determination from the attending veterinarian.
Unlimited renewal: May 2023
AN: 00156/2023
Page 2 of 5
Use of the product should be based on susceptibility testing of the
bacteria isolated
from the animal. If this is not possible, therapy should be based on
local (regional,
farm level) epidemiological information about susceptibility of the
target bacteria.
Official, national and regiona
                                
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