A-H Injection — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

A-H Injection

Active ingredient

Chlorobutanol Doxylamine Succinate

Application type

NADA

Sponsor

Intervet, Inc.

Applications on record

1

First published

June 1, 2016

Adverse event reports

Source: openFDA VeDDRA

8

Reports mentioning this ingredient

August 21, 2012 – October 5, 2016

4

Classified serious

per reporter assessment

3

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 “CHLOROBUTANOL ANHYDROUS; NOVOBIOCIN; PENICILLIN G PROCAINE”. 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
Lack of efficacy (bacteria) - NOS	3
No sign	2
Death	2
Closure, Abnormal	2
Urticaria	1
Sudden death	1
Residues in milk	1
Underfilling, Container	1
Containers, Damaged	1
CULTURE/TITER DATA ABNORMAL	1
General illness	1
Containers, Leaking	1
Death by euthanasia	1
Lack of efficacy - NOS	1

Species affected

Source: openFDA VeDDRA

Cattle 5

Regulatory context

New Animal Drug Application (NADA). A pioneer approval evaluated for target animal safety, therapeutic effectiveness, manufacturing controls and — for food-producing species — human food safety including residue depletion.

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