Product monographs

A general chapter giving the dissolution test for solid oral dosage forms was first described in the EP in 1991 (20). As mentioned above, the EP has no product monographs in which to elaborate specific dissolution procedures. 

Bioavailability, dissolution and stability study data Regulatory status in other countries Marketing information Proposed product monograph... 

Antihyperlipidemics Use HMG-CoA reductase inhibitors in addition to a diet restricted in saturated fat and cholesterol when diet and other nonpharmacological therapies alone have produced inadequate responses. Refer to individual product monographs. ... 

Product monograph Plavix, http //www.sanofi-aventis.ca/products/en/plavix.pdf (May 30, 2009). 

Pulmozyme . Product Monograph Hoffmann-Laroche Lid., Basel, 199d... 

The 1996 Canadian Product Monograph for sumatriptan (but not the 1998 US package insert) listed the combination of sumatriptan and lithium as contraindicated. However, in a review, there was little evidence of a severe interaction of sumatriptan with lithium (692). 

G.P. Merck Frosst-Scherrng Pharma, Product Monograph Ezetrol. http //www.merck-frosst.ca/mfcl/en/corporate/products/ezetrol.html, 2009 (4 July 2010). 

Alpha therapeutic corporation. In FLUOSOL 20% Product Monograph Alpha Therapeutic Corp. Los Angeles, 1990. 

Ivanitsky, G.R. Vorobyev, S.I. Perftoran blood substitute with gas-transporting function Product Monograph Perftoran Co. Pushchino, Russia, 1997. 

It is also essential to include clinically significant protein binding information in the product monograph. In the clinical setting, the information should help explain the inter and intrapatient variations in pharmacokinetics that would be reflected in variable pharmacodynamic effects and would certainly indicate... 

This guideline has been the most influential document in LAL testing to date. Annual updates of the Appendix E, endotoxin limits for established parenteral products, were published by the FDA until 1994. With the upgrades in test procedures and endotoxin limits published in individual product monographs, the FDA no longer has a need to revise the 1987 guideline. 

Copy of proposed production monograph and master batch record ... 

Janssen-Ortho Inc, in association with Health Canada, have issued a Dear Health Professional letter about the addition of a boxed section to the product monograph of epoetin-alfa (Eprex). The addition recommends that epoetin alfa should be administered intravenously rather than subcutaneously in patients with chronic renal insufficiency. This advice is based on the fact that most of the worldwide reports of pure red cell aplasia in patients treated with epoetin alfa have been associated with subcutaneous administration. 

The detailed product monograph giving description, actions, indications, dosage, administration, warnings, precautions, interactions eind adverse reactions is to be forwarded together with the layout of the proposed label cmd carton texts. 

Product particulars as they normally appear in product monographs, package inserts and drug information sheets. 

Bioavailability, adverse effects, product pharmacological and pharmacokinetic data, etc.—brief summaries of the product s adverse effects and bioavailability data are to be provided in section C2j to C2m of the application form. Alternatively, the summaries can be enclosed separately in which case the enclosures should be properly labeled and flagged. Statements such as refer to the package insert or refer to product monograph are not acceptable. 

The promotional materials that are used by pharmaceutical company staff at their company booth for advertising products to conference delegates at international congresses must be produced and certified for use, in accordance with the legal and self-regulatory frameworks in the applicable countries. These promotional materials include printed detail aids, electronic detail aids, leave pieces and product monographs. 

Special warnings, precautions or use limitations cited in the product monograph should be included in the body copy. Examples include abuse potential for narcotics or central nervous system agents, or specific directions for use in special patient groups such as elderly people, children, pregnant women, nursing mothers, women of childbearing age. 

Promotional and educational material available at the display shall not present information or claims that differ in any way from the official product monograph(s). 

Indications for use of a pharmaceutical product must conform to the Health Canada-authorised product monograph or, if there is no monograph, the accepted prescribing information. If neither of the above exists, the Commissioner will make an evaluation after consultation with the appropriate Health Canada official(s) and clinical consultants. 

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