Information leaflets

Please provide an appropriate patient information leaflet providing a full explanation of the nature, purpose, procedures and risks associated with the study and consent form. 

The DRA in Venezuela allows prescription drugs to be advertised in the press on a onetime basis as an announcement that the dmg is now registered in Venezuela. Information presented in the promotion and advertising materials must be based on the product information, as specified in the summary of product characteristics (SPC), approved at the time of registration. In all countries except Australia, patient information leaflets and labels are also subject to approval. In Australia, although approval is not needed, the information must not conflict with the approved product information. 

There are many successful examples of compliance packaging in the marketplace. These include oral contraceptives, unit-of-use packaging for steroids, convenience paks, and blister packaging systems that incorporate reminder and information leaflets (the MACPAC). 

In our meta-analysis, more than half of the clinical trials submitted to the FDA showed no difference between drug and placebo. Most reviewers of the clinical-trials literature have not had access to unpublished studies and may not even know of their existence. But the FDA and other regulatory agencies around the world knew of these data. Nevertheless, their existence is not even mentioned in the product labels, information leaflets and official Summaries of Product Characteristics (SPC) of most antidepressants. 

Perhaps it is not without reason that in Italy a patient information leaflet is sometimes called a bugiardino - literally, little liar . 

Wehrle-Werk AG information leaflet Biomembrat( )-plus , wmv.wehrle-werk.de, 2001. 

The Risk Assessment model comprises (1) prediction of the concentration that will reach the enviromnent (PEC), (2) prediction of the no-effect concentration (PNEC) on a small selection of organisms (3 species), and (3) propose possible minimization measures which will be inserted, in form of standard sentences, in summary of product characteristics (SPC) and/or patient information leaflet of respective Medicinal Product [125]. 

Patient information leaflets are intended to provide information about the medicine to the patient. The leaflets are produced for many medicines whether presented as original packs or patient packs. For medicines presented in bulk dispensing packs, the manufacturer may supply additional copies of the leaflet. Within the European Union, Directive 92/27/EEC outlines the contents of patient information leaflets and the use of the rINN is required. 

Identify the essential information which the patient will want to know and which the patient needs to know and prepare a patient information leaflet. 

In the United States, the FDA had first required patient information leaflets in 1970. Following consultations with the Pharmaceutical Society, the ABPI, BMA, Health Council and other bodies, regulations on leaflets (SI 1977/1055) were introduced to make sure that the public had greater information on the medicines they were prescribed. 

An application for a marketing authorisation must be accompanied, among other items, by specified pharmaceutical, preclinical and clinical particulars and documents (the dossier ). Three important summary documents in the dossier are the SPC, a Package or Patient Information Leaflet (PIL), and the sales presentation of the product (label). The SPC has a formally prescribed structure (Box 17.1), and forms the basis for authorised chnical prescribing of the medicinal product concerned. 

Part I was a summary of the information presented in the whole dossier and included the application forms and administrative particulars on fees, various declarations and the t)rpe of application as well as particulars of the marketing authorisation (lA), proposed SPC (IBl), proposals for packaging, labels and package or patient information leaflets (IB2), and any SPCs already approved in the Member State(s) for the particular product (IB3). Also included were separate Expert Reports on chemical and pharmaceutical (ICl), pharmacotoxicological (preclinical) (IC2), and chnical documentations (IC3), as... 

The prices of generic medicines must inevitably rise in the near future as manufacturers move to produce patient packs, which will be required to contain patient information leaflets. Under EC legislation, bulk containers will almost inevitably be phased out of production (except perhaps for hospital use). 

Full details are given in the HSE information leaflets obtainable as given below see also RSC (1996). Before the commencement of any work that involves or creates substances that may be hazardous to health, the risks, control measures and disposal procedures to be adopted should be assessed and recorded on appropriate forms. These should be signed by the assessor, and where appropriate by the student, and then countersigned by the Head of Department. One copy should be kept for local reference in the laboratory, with the original filed centrally for inspection by external inspectors. Only after this, should any new chemicals be ordered by a designated person (or deputy) who should check that the COSHH form has been duly completed. COSHH guidelines may be summarized in seven points ... 

Anon (1983). Metering of Inorganic Pigments in the Manufacture of Coloured Concrete Products Technical Information Leaflet, Mobay Chemical Corporation, Pittsburg, PA, USA, 6. 

Kerry had a one-year history of heroin use before undergoing a straightforward community detoxification with lofexidine and symptomatic medication. She was keen to go on naltrexone, and we supervised the first half-tablet dose, eight days after her last use of heroin. Her mother had helped her through the detoxification at home, and was also going to make sure that Kerry had her naltrexone each day. They were given a patient information leaflet, and a medical warning card for Kerry to carry with her at all times. 

Portmann, J.E. and K.W. Wilson (1971). The toxicity of 140 substances to the brown shrimp and other marine animals. Shellfish Information Leaflet 22, 2nd edn. Bumham-on-Crouch, Essex and North Wales. Ministry of Agriculture Fisheries and Food, Fisheries Laboratory. Fish Experimental Station Conway. 

According a report published by the American Medical Association Ad Hoc Committee on Health Literacy, more than 40 percent of patients with chronic illnesses are functionally illiterate, and almost a quarter of all adult Americans read at or below a fifth grade level. Unfortunately, medical information leaflets typically are written at or above a tenth grade reading level. It is estimated that low health literacy skills have increased our annual health care expenditures by 73 billion. Further contributing to the dilemma is the fact that an estimated three-quarters of patients throw out the medication leaflet stapled to the prescription bag without reading it, and only one-half of all patients take their medications as directed (AMA, 1999). 

Current textbooks state that antidepressants are 20% to 40% more effective than placebo, achieving an average 60% response rate compared to placebo response rates of between 20% and 40% Dubovsky, Davies, Dubovsky 2001 Gelder, Mayou, Cowen 2001). The Royal College of Psychiatrists information leaflet states that antidepressants produce substantial improvement in 50-65% of people compared with 25-30% of people given placebo tablets (Royal College of Psychiatrists 2007). 

Cases with more than two categories - patient preferences among three information leaflets... 

Table 17.9 Educational levels and knowledge scores after reading revised information leaflet...

Figure 17.6 Relationship between educational Level and score for knowledge after reading information Leaflet...

GlaxoSmithKline. (2003, June 18). Dear Healthcare Professional. GlaxoSmithKline would like to warn you of changes to the Patient Information Leaflet (PIL) for Seroxat (paroxetine). Uxbridge, Middlesex, UK. 

Possible adverse effects Ciclosporin has many adverse effects. It would be prudent to discuss the most significant effects and offer to return when she has had the opportunity to read through a patient information leaflet. 

When a patient collects his or her first instalment of methadone/buprenorphine an appropriate information leaflet should be supplied, giving advice on how to use the product, special warnings, precautions and drug instructions. 

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