Tramisol®-X-Tra Cattle Anthelmintic and Extoparasitic Paste

Overview

Source: Animal Drugs @ FDA

Proprietary name

Tramisol®-X-Tra Cattle Anthelmintic and Extoparasitic Paste

Active ingredient

Famphur Levamisole Resinate

Application type

NADA

Sponsor

Intervet, Inc.

Applications on record

1

First published

June 1, 2016

Adverse event reports

Source: openFDA VeDDRA

264

Reports mentioning this ingredient

November 25, 1987 – November 22, 2009

0

Classified serious

per reporter assessment

17

Lack of expected efficacy

resistance signal

67

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 “FAMPHUR”. 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
Unclassifiable adverse event	138
Death	68
Accidental exposure	67
Hypersalivation	30
Eye irritation	22
No sign	19
Recumbency	17
Abortion	16
Lack of efficacy (ectoparasite) - lice	14
Diarrhoea	13
Nausea	12
INEFFECTIVE, GRUBS	12
Vomiting	11
Ataxia	10
Depression	10
Dyspnoea	9
Fever	8
Collapse (see also 'Cardio-vascular' and 'Systemic disorders')	8
Eye pain	8
Ruminal bloat	6

Species affected

Source: openFDA VeDDRA

Cattle 122 Human 114 Dog 6 Other 5 Buffalo 3 Other Birds 3 Eagle 1 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