Drug regulatory requirements specification
The specification must include the following: drug name, ingredients, indications or functions, usage, dosage, adverse reactions, contraindications, precautions, specifications, expiry date, approval number and manufacturer.
Drug description must also include pregnant and lactating women, drug interactions, or lack of reliable experimental basis for the literature and can not be expressed, to retain the title and description should be marked 'not clear.'
Drug description should also include clinical research, pediatric, elderly and drug overdose, toxicology and pharmacokinetics lack of reliable experimental basis or can not be expressed in literature, brochures no longer retain the title.
Chemicals, therapeutic biological products, traditional Chinese medicine, preventive biological product specification writing specific content and format in accordance with << treatment chemicals and biological products description specifications Details >>, << Details >> Specification Manual medicine, preventive << biological products specification specification Details >> regulations.
Drug Instruction forefront is usually the name of the drug and the approval number. Drug approval number by the State Food and Drug Administration approved the issuance, reading 'Zhunzi ***** number.' If you write that 'a guard Yaozhun No. *** ', expressed approval of the drug manufactured by the provincial administrative department of medicine, if it is' Wei Zi No. lose medicine *** ', it means the drug is imported from abroad and enter manufacturing.
1. The name of the drug: usually divided into trade name or generic name, chemical name common name and chemical name world-wide, there's no textbook or article should be the same name, in English and translations in general represent regards trade name, every one. pharmaceutical production can take a trade name for its products. Therefore, the same pharmaceutical composition, or the chemical name of the same drug, there may be more than one trade name under various trade names, meaning that products from different manufacturers, but also means that different quality when medication should look for common name or chemical name, to avoid duplication of medication, leading to overdose.
2. Main components: Some drugs have a single component, some of the compound ingredient medicines in combination products are mostly prescription drugs is unilateral majority specification indicated more as a main component, such as cold clear main component of Radix, mountain sesame, Andrographis... Wait.
3. Indications: also known as the role and use of drugs that, according to the pharmacological effects and clinical application, the FDA does have the disease will be included in the efficacy of this popular range of indications 'function with some proprietary specification. indications 'said. medication must be in a range of indications, in particular otc (non-prescription drugs should be taken in accordance with the indications and avoid the wrong clothes.
4. usage and consumption: the amount of the drug usually refers to the instructions on the adult dose, children will have to calculate the dose depending on the age or body weight in many western medicine weight in grams (g, milligrams (mg et indicated capacity milliliters (ml expressed, and. 1 g = 1000 mg, 1 liter = 1000 ml scaling. as each piece of 0.5 g and 500 mg per tablet are the same notation. drug dosage often stated several times a day, how much volume each, children commonly daily the amount per kilogram of body weight is expressed. as for drug use, according to need the drug dosage form and characteristics, indicate oral, intramuscular, intravenous drug use, external use and before meals, after meals, before bedtime, etc. patient should be strictly in accordance with the instructions indicated method of medication.
5. Adverse reactions: many drugs in the course will be a variety of side effects, in addition to the characteristics of the drug itself, but also the physical and drug users, about the health if allergies penicillin, streptomycin prone. allergic reactions. some drugs will stimulate the oral gastrointestinal cause nausea, vomiting and other reactions, some drugs are toxic to the liver and kidney, these adverse reactions are noted in the instructions. Observe the adverse reactions, strengthen self-monitoring of medication, there are help in the event of adverse reactions, to take timely measures.
6. Note: For safe use of the drug, the drug must be listed with caution, avoid objects and disabled people who have contraindications, absolutely can not use the appropriate drugs, drugs to be used with caution under the guidance of a doctor close. monitoring of adverse reactions.
7. Specification: refers to the content of the drug per tablet or each.
8. Storage: This is some of the requirements in the preservation of drugs, most drugs are required to be dark, airtight and stored in a cool dry place many biological products be refrigerated or cryopreserved deterioration must not take the drug...
9. Validity, shelf life or expiration date: Many drugs are marked valid, or expired medicines was reached after the expiry expiry date, expired drugs must not be taken.
10. Lot: Lot medicines generally indicate the date of manufacture of the drug but should be noted: The date of writing some European countries imported drugs are often reversed, said day, month, year, the United States imported drugs are mostly arranged by month, day, in the arrangement, the Japanese imported drugs mostly by year, month, day arrangement, Russia and other CIS countries, the usual Roman numerals month.
How to read the package insert? Above we have a thorough interpretation of the package insert, hoping to help you understand a good description of the drug, safe and rational drug use.
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