Equigent 100 mg/ml Solution for Injection for Horses

国家: 英国

语言: 英文

来源: VMD (Veterinary Medicines Directorate)

有效成分:

Gentamicin

可用日期:

Chanelle Pharmaceuticals Manufacturing Ltd

ATC代码:

QJ01GB03

INN（国际名称）:

Gentamicin

药物剂型:

Solution for injection

处方类型:

POM-V - Prescription Only Medicine – Veterinarian

治疗组:

Horses

治疗领域:

Antimicrobial

授权状态:

Authorized

授权日期:

2018-11-01

产品特点

Unlimited renewal: May 2023
AN: 00113/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equigent 100 mg/ml Solution for Injection for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Gentamicin (as gentamicin sulfate)
100 mg
EXCIPIENTS
Sodium Metabisulphite
1.0 mg
Sodium Methyl parahydroxybenzoate (E219)
0.9 mg
Sodium Propyl parahydroxybenzoate (E217)
0.1 mg
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection.
A clear and colourless to slightly yellow solution, free from
particles.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses (non-food producing horses).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infections of the lower respiratory tract in
horses caused by aerobic
Gram-negative bacteria susceptible to gentamicin.
4.3
CONTRAINDICATIONS
Do not use in known cases of renal dysfunction.
Do not use in cases of known hypersensitivity to the active substance
or to any of the
excipients.
Do not exceed the proposed dosing regimen.
Unlimited renewal: May 2023
AN: 00113/2023
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not use in horses which are intended to produce meat or milk for
human
consumption.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Gentamicin is well known to induce nephrotoxicity even at therapeutic
doses in horses.
There are also isolated reports of ototoxicity with gentamicin. No
margin of safety has
been established under the approved dosing regimen. As such,
gentamicin has a
narrow margin of safety. The product should therefore only be used
based on the
benefit-risk assessment by the responsible veterinary surgeon for each
individual horse,
taking into account alternative available treatment.
In order to reduce the nephrotoxic risk, adequate hydration of animals
under treatment
should be ensured, and fluid therapy should be instituted, if
required.
Close monitoring of horses being treated with gentamicin