Off-Label Ltd

All OFF-LABEL products and services are independently compiled by Off-Label Ltd. Off-Label Ltd has no affiliation with any license/label holder, manufacturer, or distributor. The contents of all OFF-LABEL products are derived from data that are available within the public domain. All readers are referred to the Policy Statements below.

CONDITIONS OF SALE
©2008 Off-Label Ltd. All rights reserved throughout the world and in all languages. No part of any OFF-LABEL product may be reproduced, transmitted or stored in any form or by any means either mechanical or electronic, including photocopying, recording, or through an information storage and retrieval system without the prior permission of the copyright holder, Off-Label Ltd. All abstracting of contents for republication and sale must have prior permission from Off-Label Ltd. Off-Label Ltd is protected by the Companies Act 1985.

The contents of OFF-LABEL Database must not be circulated, distributed, or exported without prior agreement with Off-Label Ltd.

POLICY STATEMENT: GENERAL

Every effort has been made to ensure that clinical material communicated throughout all OFF-LABEL products accurately represents that which is contained within every original source cited. Readers are strongly advised to refer to the license/label of the relevant branded product(s) for further and full details, especially those details that concern the clinical significance of the active ingredient’s reported and assigned contraindications, special precautions, drug interactions, adverse reactions, or overdose. Although great care is taken in compiling the contents of all OFF-LABEL publications and reference sources, the publisher makes no claim that it is free of error. Under no circumstances does any OFF-LABEL publication or reference source diminish the need to exercise clinical judgement, and neither Off-Label Ltd nor its associates can accept any responsibilities for their use in practice.

POLICY STATEMENT: OFF-LABEL Database/Use of the term off-label

Published reports of off-label uses cited by us have been identified following interrogation of databases using pharmacopoeial or other non-proprietary/generic titles of each drug as a key term. No comment is made on methodologies or outcomes. Off-label uses are reported by us regardless of whether the outcome(s) suggests positive benefit, no benefit, or an adverse effect(s). It remains the responsibility of the user to refer to the full manuscript for which we provide short-format bibliographic details together with a hyperlink to the PubMed citation.

For each citation we make no claim that the source cited includes details of any use of the products listed using proprietary or non-proprietary/generic branded titles, under the heading BRAND.

In some cases, a formulary preparation may have been used as an alternative to available proprietary or non-proprietary/generic formulations; consequently, available doses and bioavailability may differ. Such preparations must be considered as unlicensed, and caution must be exercised in the interpretation of study outcomes. Consideration should be given to possible reasons that may have motivated the use of a formulary preparation. In some cases use of a novel formulation/route of administration may represent clinical evaluation as part of a new license application or supplement to an existing license.

Indications and uses summarized under the heading License/Label Summary are those that relate strictly to the posology and routes of administration detailed within the license/label. For the same drug, brand names and/or manufacturer (i.e. ‘company’) may change according to the country in which it is marketed. Dosages and/or route(s) of administration used in the study cited may not correspond with or be representative of those detailed in the license/label. Patient populations defined within the study cited may not correspond with those approved within the license/label.

For some citations a new report of an off-label use represents a potential off-label use based upon an incidental finding in a study in which the drug(s) may have been used within the framework of the license/label. Likewise, we occasionally report a potential off-label use that represents a new interpretation of historical data following a retrospective analysis.

Licensed uses may differ between different branded versions containing the same active ingredient.

Any provision of contact details for further information must not be interpreted to imply that any manufacturer(s) listed endorses or promotes any unlicensed use.