SparMectin Plus Clorsulon — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

SparMectin Plus Clorsulon

Active ingredient

Clorsulon Ivermectin

Application type

ANADA

Sponsor

Sparhawk Laboratories, Inc.

Applications on record

1

First published

March 1, 2021

Adverse event reports

Source: openFDA VeDDRA

491

Reports mentioning this ingredient

January 14, 1991 – November 20, 2013

1

Classified serious

per reporter assessment

25

Lack of expected efficacy

resistance signal

60

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 “CLORSULON, IVERMECTIN”. 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
Seal, Abnormal	89
Caps, Abnormal	71
Unclassifiable adverse event	70
Death	64
Accidental exposure	60
INEFFECTIVE, PARASITE(S) NOS	31
Vials, Leaking	26
Injection site pain	23
Recumbency	21
Injection site swelling	20
Ataxia	16
INEFFECTIVE, LICE BITING	15
Trembling	14
Depression	14
Diarrhoea	14
Hypersalivation	13
Underfilling, Package	13
Anaphylaxis	12
Collapse (see also 'Cardio-vascular' and 'Systemic disorders')	12
No sign	12

Species affected

Source: openFDA VeDDRA

Cattle 173 Human 56 Dog 35 Sheep 6 Horse 6 Cat 5 Goat 2 Buffalo 1 Mule 1 Guinea Pig 1 Other Deer 1 Other 1

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