AmiMaxTM E Solution — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

AmiMaxTM E Solution

Active ingredient

Amikacin Sulfate

Application type

ANADA

Sponsor

Elanco US Inc.

Applications on record

1

First published

May 22, 2017

Adverse event reports

Source: openFDA VeDDRA

12

Reports mentioning this ingredient

February 17, 2013 – April 6, 2020

4

Classified serious

per reporter assessment

1

Lack of expected efficacy

resistance signal

0

Human operator exposure

needle-stick or splash

Not a risk measure. Veterinary adverse event reports are influenced by how many animals are treated, reporting practice and product age. Reports do not establish that the product caused the event, and a single report can cover an entire herd or flock. Attribution here is by active ingredient because the source dataset redacts brand names.

Attributed by active ingredient “AMIKACIN SULFATE”. Green Book ingredient names and VeDDRA ingredient names do not always agree exactly, so attribution is approximate and labelled as such.

Reported reactions

Source: openFDA VeDDRA

Clinical signs coded in the VICH VeDDRA four-level hierarchy, most frequent first.

Reaction terms reported for this ingredient, by report count.
Reaction (VeDDRA term)	Reports	Relative frequency
No sign	3
Uncoded sign	2
Solution, Abnormal	2
Color, Abnormal	2
Vocalisation	1
Facial swelling (see also 'Skin')	1
Unable to stand	1
Urinary incontinence	1
Precipitate, Sediment	1
Lethargy (see also Central nervous system depression in 'Neurological')	1
Inappetence	1
Renal failure	1
Lack of efficacy - NOS	1
Contamination, Insects	1
Containers, Abnormal	1
Underfilling, Container	1
Feet shifting	1
Tachycardia	1
Fever	1
Lameness	1

Species affected

Source: openFDA VeDDRA

Dog 4 Horse 2

Regulatory context

Abbreviated New Animal Drug Application (ANADA). A generic animal drug demonstrating bioequivalence, pharmaceutical equivalence and identical manufacturing criteria to the pioneer application. Veterinary generics have no formal therapeutic-equivalence coding system; they match the pioneer NADA specification instead.

Extra-label use in food-producing animals is governed by the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) and 21 CFR Part 530. It requires a valid veterinarian-client-patient relationship and is prohibited outright for certain drug classes. Withdrawal times are determined by FARAD, not by this index.

Sources for this page

Animal Drugs @ FDA	FDA CVM	Applications, sponsor, status, withdrawal
Animal & Veterinary Events	FDA CVM	VeDDRA adverse event aggregates by active ingredient