Oxyglobin® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Oxyglobin®

Active ingredient

Hemoglobin Glutamer-200 (bovine)

Application type

NADA

Sponsor

OPK Biotech, LLC

Applications on record

1

First published

June 29, 2018

Adverse event reports

Source: openFDA VeDDRA

29

Reports mentioning this ingredient

July 14, 1998 – October 14, 2005

0

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 “HEMOGLOBIN GLUTAMER-200 (BOVINE)”. 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
Death	15
Death by euthanasia	6
Apnoea	6
Oedema of the extremities (see also other SOCs for most applicable oedema)	5
Fever	4
Cardiac arrest	4
Anaphylaxis	3
Facial oedema	3
Hypotension	3
Pale mucous membrane	2
Pruritus	2
Elevated alanine aminotransferase (ALT)	2
Elevated total bilirubin	2
Skin slough	2
Horizontal nystagmus	2
Arrhythmia	2
PR-KIDNEY(S), LESION(S)	1
PR-LIVER, LESION(S)	1
Dyspnoea	1
PR-LUNG(S), LESION(S)	1

Species affected

Source: openFDA VeDDRA

Dog 26 Pig 2 Cat 1

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