What is a pharmaceutical monograph?

What is a pharmaceutical monograph?

A Product Monograph is a factual, scientific document on a drug product that, devoid of promotional material, describes the properties, claims, indications and conditions of use of the drug and contains any other information that may be required for optimal, safe and effective use of the drug.

How do you write a drug monograph?

Patient Information:

1. Name and description of the medication.
2. Dosage form.
3. Route of administration.
4. Duration of therapy.
5. Special directions and precautions.
6. Side effects.
7. Techniques for self-monitoring.
8. Proper storage.

What are the components of a drug monograph?

Drug monograph: This document includes the drug name, therapeutic class, pharmacology, indications for use, summary of clinical trials, pharmacokinetics/dynamics, ad- verse effects, drug interactions, dosage regimens, and cost.

What is a Health Canada monograph?

The Compendium of Monographs can help speed the evaluation of the safety and efficacy of medicinal ingredients commonly used in natural health products. A monograph is a written description of particular elements on an identified topic. Monographs are now accessible via the Natural Health Products Ingredients Database.

What is an example of a monograph?

An example of a monograph is a book on how the human body uses Vitamin D. A scholarly book or a treatise on a single subject or a group of related subjects, usually written by one person. To write a monograph on (a subject).

What is an FDA monograph?

An OTC monograph is a “rule book” for each therapeutic category establishing conditions, such as active ingredients, uses (indications), doses, labeling, and testing, under which an OTC drug is generally recognized as safe and effective (GRASE) and can be marketed without a New Drug Application and FDA pre-market …

What is monograph prescribed for?

A publication that specifies for a drug (or class of related drugs) the kinds and amounts of ingredients it may contain, the conditions and limitations for which it may be offered, directions for use, warnings, and other information that its labeling must contain.

What is a monograph used for?

Unlike a textbook, which surveys the state of knowledge in a field, the main purpose of a monograph is to present primary research and original scholarship ascertaining reliable credibility to the required recipient.

What other drugs are made by AstraZeneca?

Country specific information is available from your local AstraZeneca company.

• Atacand, Atacand HCT, Atacand Plus. candesartan cilexetil.
• Crestor. rosuvastatin.
• Lokelma. Sodium zirconium cyclosilicate.
• Seloken ZOK, Toprol-XL, Betaloc ZOK. metoprolol succinate.
• XIGDUO XR. dapagliflozin and metformin HCI extended-release.

Where can I get drug monographs?

Prescription and Non-prescription Monographs

• RxList. The Internet Drug Index – part of the WebMD network.
• Drugs.com. Data sources include the Physicians’ Desk Reference (PDR), Cerner Multum, Thomson Reuters Micromedex and Wolters Kluwer Health.
• Medscape Drugs & Diseases. Free registration required – from WebMD.
• RxFiles.

What is personal monograph?

A monograph is a specialist work of writing (in contrast to reference works) or exhibition on a single subject or an aspect of a subject, often by a single author or artist, and usually on a scholarly subject. …