Standard Editorial Notes
Product entries are:
- compiled independently of manufacturer but in a manner which accurately reflects the contents of the official product literature, processed by the publisher, in a standard format. Pharmaceutical companies which choose to have their products listed check their proofs regularly.
- intended to be brief, concise and practical.
- a reminder/alert to the doctor (i.e. they assume that, given basic information/key words, the doctor will know what action to take, or where to obtain further information).
- listed alphabetically by proprietary name within the applicable active ingredient, product, pharmacological classification and manufacturer subsections. Should the indications for any product make it relevant to more than one pharmacological classification, the full MIMS entry will appear under both pharmacological classifications.
- compiled making extensive use of abbreviations. Great care has been taken to ensure that no difficulty in understanding the meaning of the abbreviations will be experienced. As far as possible, consistency in these abbreviations has been implemented.
- not inclusive of inactive ingredients where applicable (e.g. sugar/alcohol content, preservatives etc.). For detailed information please refer to the current MDR where applicable, the current package insert or the relevant pharmaceutical company.
- The extent of information will not be the same for all products. This depends largely on the package insert. The C/I, S/E, S/P and D/I of old medicines not yet called up for registration may appear to be inconsistent in comparison to newly registered products with the same active ingredients. If C/I, S/E, S/P or D/I have not been specified it should not necessarily be accepted that none apply. In cases where an applicant has different products appearing in the same pharmacological classification and which contain the same active ingredient, the safety aspects are only included under one listing and the other listings cross-referenced.
- Pregnancy and breastfeeding have been listed under the heading C/I where the product is known to be dangerous to the foetus during either pregnancy, labour or lactation. When included under S/P, this should alert the prescriber to a known risk of adverse reactions in these circumstances. In the absence of adequate studies in pregnant and lactating women, all medicines carry a potential risk to the foetus and, if they are excreted into milk, to the breastfed infant. The risk:benefit ratio must be established.
- Renal and/or liver dysfunction of any severity may increase plasma concentrations and prolong the action of many medicines eliminated mainly by these routes and may therefore increase the risk of side-effects. Attention has been drawn to specific products where toxicity is known to have occurred. Prescribers are reminded that caution is necessary when prescribing any medicine to a patient with significantly impaired renal or liver function.
- Children: Where dosage recommendations for any product are not specified for children, prescribers should be aware that this may indicate that safety and efficacy have not been formally established in children, although there may be some clinical experience in this age group. Administration to children should only be contemplated after careful consideration of the benefit:risk ratio, and should no alternative medicines be available.
- Active salt: In order to assist practical prescribing, MIMS publishes the mass of the active ingredient as a salt or other combination (if applicable) as if it is prescribed to the patient and not the actual mg or molar content of the active entity. Eg. Amlodipine mesylate will be prescribed as 1.5 mg Amlodipine. For accurate details on the mg or molar concentration of the active substance the prescriber is referred to the MDR or package insert of the branded product.
- Only registered indications for products are listed. Prescribers must weigh the benefit against risk when using products "off label".
- Prices: MIMS reflects the single exit price inclusive of VAT in line with pricing legislation (Government Notice, Gazette No 26304 of 30 April 2004). Prices do not reflect interim price adjustments. Prescribers are reminded that this price excludes any professional fees that may be applicable and will not necessarily be what their patients will pay.
- When prescribing any product listed in MIMS, doctors should be mindful of the important points appearing randomly throughout the text. It should be noted that these aspects will not necessarily appear in the product listing. Only where they are of clinical significance to the product have they been included.
- MIMS is amended each month. When in doubt or when full information is required, consult the current MDR where applicable, the current package insert or the relevant pharmaceutical company. For any product not listed in MIMS, please consult the relevant package insert.
- In certain cases and specific categories where information cannot be adequately summarised, cross-reference to full prescribing information has been made by either a reference to MDR if the product is fully detailed, or otherwise to the manufacturer. We have called such entries ‘product identification listings’ which give only the following: proprietary name, applicant, registration/reference number, active ingredient, scheduling status, presentation, indications, strength, pack and price.
- MIMS is an index of information and reference, and not an assessment of the various preparations. Dependent on the participation of pharmaceutical companies, MIMS has been made as complete as possible in its product listings.
- Every effort has been made to ensure the accuracy of the information published in this product. The publisher and their employees, agents or editors, however, cannot accept responsibility for the currency of the information or for any errors in copy or printing, omissions or for changes, etc., which may have occurred before, during or after publication, and shall, furthermore, not be liable under any circumstances whatever for any damages suffered as a result of any such errors, omissions or changes.
Unscheduled and schedule 1 and 2 medicines are only listed in MIMS, if they are:
- not advertised directly to consumers; or
- when they are advertised in consumer media, but generate more than 10 000 scripts p.a. (Source: NDTI)