International trade name of medicines. International generic names of medicines: history, purpose, search for analogues and synonyms
· Batch of medicinal product - quantity of medicinal product produced as a result of one technological cycle by its manufacturer.
· Registration certificate of a medicinal product - a document confirming the state registration of a medicinal product.
Registration number - a code designation assigned to a medicinal product during its state registration.
Expiration date - this is the period after which the product (work) is considered unsuitable for its intended use (Article 5 of the "Law on the Protection of Consumer Rights"
· Counterfeit medicinal product - a medicinal product accompanied by false information about its composition and (or) manufacturer.
· Poor-quality drug - a drug that does not meet the requirements of a pharmacopoeial article or, in its absence, the requirements of regulatory documentation or a regulatory document.
If a mistake is made in the label when dispensing a drug manufactured in a pharmacy, then this drug is a counterfeit drug. This fact is a violation of license requirements.
4. Labeling of medicinal products of industrial production.Upon receipt of medicinal products to the pharmacy organization, an acceptance control is carried out, an integral part of which is the verification of compliance of the labeling of medicinal products with the requirements of Federal Law-61.
Medicinal products must enter the pharmacy organization if the following labeling requirements are met:
1. On the primary packaging, in a well-readable font in Russian, the following should be indicated: the name of the medicinal product under the international non-proprietary or chemical or trade name. batch number expiration date dose and form of release
2. On their secondary (consumer) packaging, in a well-readable font in Russian, the following should be indicated: the name of the medicinal product (international non-proprietary or chemical and trade names; for example: captopril - capoten; diphenhydramine-dimedrol) the name of the manufacturer of the medicinal product serial number date of issue marketing authorization number expiration date method of administration dose and number of doses per pack form of release conditions of dispensing storage conditions precautions for the use of the medicinal product warning labels
3. For IBMP, the date of release, volume and number of doses are additionally indicated on the primary packaging; on the secondary packaging - the date of issue
4. Medicinal products as sera must be put into circulation with an indication of the animal from whose blood, blood plasma, organs and tissues they are obtained.5. The secondary (consumer) packaging of medicinal products obtained from blood, blood plasma, organs and tissues of a person must bear the inscription: "Antibodies to HIV-1, HIV-2, hepatitis B virus and surface antigen of hepatitis B virus are absent."
6. A radiation hazard sign must be applied to the primary packaging and secondary (consumer) packaging of radiopharmaceuticals.7. The secondary (consumer) packaging of homeopathic medicinal products shall bear the inscription: "Homeopathic".8. The secondary (consumer) packaging of medicinal herbal preparations should bear the inscription: "The products have passed radiation control."9. A bar code is applied to the secondary (consumer) packaging of the medicinal product. 5. Labeling of substances and design of labels for rods Pharmaceutical substances should be put into circulation if their primary packaging in a well-readable font in Russian indicates the name of the pharmaceutical substance (international non-proprietary or chemical and trade names), the name of the manufacturer of the pharmaceutical substance, the batch number and date of manufacture, the quantity in the package and units of measurement, quantity, expiration date and storage conditions. After acceptance, the pharmacist technologist pours / pours the substances into a special pharmacy container - shanghlas. . These barbells are usually much larger than for the assistant's room. Today, order No. 751 specifies the requirements for the main label on the barbell: name of the medicinal product date of filling the barbell with the drug expiration date (valid until ____) person's signature who fills in the barbell and confirms that the barbell contains exactly the specified drug. Signatures are usually made on an additional label and are located in the back of the barbell. Historically, the label is written in Latin. Based on the requirements of Federal Law-61, the name of the medicinal product is indicated under the INN or chemical and trade name. Label colors are also not defined by regulatory documents. Pharmacy organizations continue to use racks with the following color distribution: For narcotic substances and psychotropic drugs - on a black background in white letters For pharmacologically active drugs (having the highest single and daily dose - on a white background in red letters For the rest medicines - on a white background in black letters. The highest single and daily doses are indicated on the bars in pharmacologically active medicines.
For the convenience of working in pharmacy organizations, the price of the product is often indicated on the barbells.
Bars with substances intended for the manufacture of sterile medicinal products must have a warning label “For sterile medicinal products”.
Stem glasses with tinctures, liquid semi-finished products must be equipped with normal dropmers or pipettes. To prevent errors when filling the stem glas, the pharmacy must have a duplicate set of stem glases. Figure 3. Examples of the design of the barbells 6. Registration for dispensing of pharmaceutical products Pharmaceutical organizations, veterinary pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities manufacture medicinal products according to prescriptions for medicinal products, according to the requirements of medical organizations, veterinary organizations in accordance with the rules for the manufacture and dispensing of medicinal products approved by the authorized federal executive body. Pharmacy organizations, veterinary pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities are responsible for non-compliance with the rules for the manufacture and dispensing of medicinal products in accordance with the legislation of the Russian Federation.
All medicinal products manufactured and packaged in a pharmacy organization or by an individual entrepreneur licensed for pharmaceutical activities are issued with appropriate labels. The procedure for issuing labels is approved by Appendix 1 of Order No. 751n of October 26, 2015 “On Approval of the Rules for the Manufacture and Dispensing of Medicinal Products for Medical Use by Pharmacy Organizations, Individual Entrepreneurs Licensed for Pharmaceutical Activities”
The dimensions of the labels are determined in accordance with the dimensions of the dishes or other packaging in which the manufactured medicinal products are dispensed.
Labels for the design of medicines, depending on the method of their use, are divided into 4 groups and have certain signal colors on a white background (Table 3).
Table 3
Table of color correspondence to the ways of using drugs
For medicinal products requiring special storage, handling and use conditions, additional warning labels may be printed or pasted on the labels. (Table 4).
Dear customers!
For your convenience, we have expanded the possibilities of searching for medicines available in the pharmacy network.
Now there are two search options on the site:
According to the International non-proprietary name - INN;
- according to the common trade name of the drug.
To search, it is enough to specify only a few alphabetic characters (at least 3), which is convenient if, for example, you are not sure how to spell this or that name of the drug.
We remind you that the INN is the unique name of the active substance or active substances recommended by the World Health Organization (WHO). Thanks to the INN, doctors and pharmacists have the opportunity to navigate the huge and constantly changing range of the pharmaceutical market, and medical institutions to make the necessary purchases of medicines.
Medicines with different trade names given to them by pharmaceutical manufacturing companies and often sold in a different dosage form can have the same INN.
For example, by typing in the search bar on the site the word " diclofenac"(one of the most common INNs), we get an extensive list of drugs. Only in Russia today about 170 drugs containing this active substance with antirheumatic action are registered:
Another example is the search for preparations based on sterile isotonic sea water for washing and cleansing the nasal cavities, restoring free nasal breathing:
| INN | TRADE NAMES OF DRUGS |
| SEA WATER (AQUA MARINA) | AQUA MARIS AQUALOR MARIMER QUICKS OTRIVIN SEA HUMER PHYSIOMER |
What should I pay attention to regarding INN?
1. INN is always indicated on the packaging of the medicinal product: just below its trade name and in smaller print (in Russian or Latin).
2. INN is also indicated in reference publications about medicines.
* The list of INNs for pharmaceutical substances already includes more than 8000 names, and every year WHO registers 120-150 new ones.
** In the information resources of Russia, you can find by no means the entire list of names registered by WHO.
3. The search for medicines by INN is convenient and justified when it is necessary to purchase high-quality generic drugs that have one active ingredient (INN), but are sold in pharmacies under different brands.
4. Please note that originator and generic products DO NOT NEED to be bio- or therapeutically equivalent!
What should I pay attention to regarding the trade name of the drug?
1. Trade names are often referred to as proprietary and commercial. The bottom line is that manufacturing companies are trying to assign brand names to their products, which allows them to market and advertise drugs of their own production to consumers.
2. Trade names are most often mentioned in advertising and are always present on the packaging of drugs (indicated in large print!).
3. Trade names of many drugs are brands. Brand names are given to all original drugs, the right to manufacture which within a certain period belongs exclusively to the developer company (a patent for monopoly production is given for 5 years).
Subsequently, other pharmaceutical companies get the right to use the same INN in the production of their own drugs with other trade names - that is, generics. The production of generics is noticeably cheaper (no development costs). And consumers, accordingly, benefit from more affordable prices.
Additional information about
Names of medicines are presented in three versions: chemical, international non-proprietary and commercial.
chemical name- reflecting the composition and structure of the medicinal substance. Chemical names are rarely used in practical public health, but are often given in drug annotations and are contained in special reference publications, for example: 1,3-dimethyl-xanthine, 5-ethyl-5-phenylbarbituric acid, etc.
International non-proprietary name (INN, International Nonpro-prietary Name, INN) - This is the name of a medicinal substance recommended by the World Health Organization (WHO), accepted for use throughout the world in educational and scientific literature in order to facilitate the identification of a drug by belonging to a certain pharmacological group and in order to avoid bias and errors. A synonym for INN is the term generic, or generic name. Sometimes the INN reflects the chemical structure of the medicinal substance, for example: acetylsalicylic acid, acetaminophen.
Trade name of the medicinal product- the name of the medicinal product assigned by its developer;
Proprietary trade name (Brand name) - about but is assigned by pharmaceutical companies that produce this particular original drug and is their commercial property (trademark) protected by a patent. For example, the trade name of acetylsalicylic acid is aspirin, furosemide is lasix, and diclofenac is voltaren. Trade names are used by manufacturers for marketing purposes, to promote and compete with drugs on the market.
The concept of bioequivalence of drugs
An important concept is bioavailability, which is understood as "the rate and degree with which the active substance or its active component is absorbed (absorbed) from the dosage form and becomes available at the site of action (systemic circulation)". Considering that when administered intravenously, the drug almost completely enters the systemic circulation, it can be considered that its bioavailability absolute.
The drug whose bioavailability is being studied is tested. As a rule, the tested drug is a generic drug. Compared to bioavailability reference drug (original or innovative).
Bioavailability is a key concept for understanding bioequivalence. If, after administration of the same molar concentration of the reference and test drug, their bioavailability is similar to the extent that it guarantees the same therapeutic effect and toxic effect, then we can assume that such drugs bioequivalent.
Allocate also pharmaceutical equivalence, by which it is understood that the tested drug contains an equal amount of the active substance (substances) with the reference, the same dosage form and meets comparable standards (production and quality). It is clear from the definition that if a company produces a dosage form with other excipients that significantly change the bioavailability, then such a drug will be pharmaceutically equivalent to the original one, but not bioequivalent. A similar situation can occur if the manufacturer uses components that slow down absorption to create prolonged forms. Therefore, despite the same dosage form, they will have completely different pharmacokinetic curves in serum.
A generic drug should exhibit a therapeutic effect equivalent to the original one. If drugs show a comparable therapeutic effect in clinical trials, then such drugs are considered therapeutically equivalent. It is generally accepted that the therapeutic effect depends on the concentration of the active substance in the blood plasma. Based on this provision, drugs that have the same pharmacokinetic curve will show a comparable therapeutic effect.
A bioequivalence study is a clinical study and is required to comply with GCP requirements. This is one of the guarantees of the quality and evidence of the study.
During the study, individual pharmacokinetic parameters of the substance are determined for each subject (area under the curve, C max - maximum concentration, time to reach maximum concentration, etc.). The methodology and principles for calculating these parameters are widely covered in the scientific literature.
Good Clinical Practice (Good Clinical Practice, GCP)- a standard for clinical trials covering planning, conducting, completion, validation, analysis of results, reporting and documentation, which ensures the scientific relevance of trials, their ethical acceptability and full documentation of the clinical characteristics of the investigational medicinal product. As has been repeatedly noted in domestic and foreign literature, as well as in WHO documents, the consumer properties of drugs - efficacy, safety and pharmaceutical aspects of quality - are ensured through compliance with the most important industry rules, in other words, GLP, GCP and GMP standards or codes in the process of their development. , testing and production.
GLP (GoodLaboratoryPractice, Good Laboratory Practice)- a system of norms, rules and guidelines aimed at ensuring the consistency and reliability of laboratory research results. The system has been an approved national standard of the Russian Federation since March 1, 2010 - GOST R-53434-2009. The main task of GLP is to provide the possibility of full traceability and recovery of the entire course of the study. Quality control is called upon to be carried out by special bodies that periodically inspect laboratories for compliance with GLP standards. GLP sets very strict requirements for the maintenance and storage of records - much more stringent than the European standards of the EN 45000 series. The scope of the GLP standards is established by law. First of all, this applies to the development of new chemicals, the production and use of toxic substances, and public health.
GMP(“Good Manufacturing Practice”, Good Manufacturing Practice)- a system of norms, rules and guidelines regarding the production of: drugs, medical devices, diagnostic products, food products, food additives, active ingredients
In contrast to the quality control procedure by examining random samples of such products, which ensures the suitability for use only of these samples themselves (and, possibly, batches produced in the closest time to this batch), the GMP standard reflects a holistic approach and regulates and evaluates the actual production parameters. and laboratory testing.
To standardize the quality of medical care for the population, it is used together with the standards: GLP (Good Laboratory Practice), GCP (Good Clinical Practice, GDP (Good Distribution Practice).
Pharmacovigilance- a kind of continuous monitoring of adverse events and other safety related aspects of medicines that are already on the market. In practice, pharmacovigilance relies solely on spontaneous reporting systems that allow health professionals and others to report adverse drug reactions to a central unit. Said central unit then combines reports from many sources to create a drug safety information profile based on one or more reports from one or more healthcare professionals.
Toxicity – the property of a substance, when it enters the human body in certain quantities, to cause poisoning or death of animals or plants.
Embryotoxicity - the ability of a medicinal substance to have a toxic effect on developing embryos; Embryotoxicity can manifest itself in three main forms: embryolethal action, teratogenic effect, general developmental delay.
Embryo-lethal action– an increase in the overall level of embryonic mortality, both pre-implantation and post-implantation.
Teratogenic effect- anatomical, histological, cytological, biochemical, neurophysiological and other abnormalities that appear before or after birth.
Generaldelaydevelopment– change in body weight, craniocaudal size, delayed ossification of the bones of the skeleton.
Carcinogenicity b - the action of a substance that can cause the development of tumors.
Mutagenicity - the action of a substance capable of causing changes in the genetic apparatus of a cell and leading to a change in hereditary properties.
Each drug can have 3 names:
full chemical name - a description of the structure of the molecule according to the international chemical nomenclature;
generic name, international non-proprietary name (INN, INN) - a name that is issued to a drug by a special committee of WHO or a national pharmaceutical committee. This name is not the intellectual property of anyone and can be used by any drug manufacturer. When choosing an MMP, 3 principles should be taken into account:
The name must have a distinct sound and spelling;
The name should not be consonant with existing drug names;
The name should reflect the generic relationship of drugs. For example, the suffix -olol for beta-adrenergic blockers, -adl - for ACE inhibitors, -sartan - for angiotensin AT 1 receptor antagonists, the prefix cefa- for cephalosporin antibiotics.
If a doctor prescribes a medicine under his INN, then he leaves the right to choose the manufacturer of the drug to the pharmacist and leaves the possibility of a generic replacement (i.e. dispensing the drug under any of its trade names) at his discretion.
4. Clinical and pharmacological characteristics of antiallergic drugs.
Allergy is a pathological process that is a consequence of hypersensitization (hypersensitivity) of the body to various substances and manifestations of a hyperimmune reaction. There are 2 types of hypersensitivity reactions: immediate and delayed. Allergic reactions of the immediate type are associated with humoral immunity, appear after a few minutes or hours: urticaria, bronchospasm, rhinitis, conjunctivitis, Quincke's edema, anaphylactic shock, etc. Allergic reactions of the delayed type form 1-2 days or more, they are associated with cellular immunity, (presence of T-lymphocytes). These are tuberculin reaction, contact dermatitis, transplant rejection reaction, bacterial allergy, autoimmune diseases, etc. In this case, immunosuppressants, corticosteroids, NSAIDs are used, which reduce tissue damage. For the treatment of allergic reactions of the immediate type, use:
Glucocorticoids
H1-histamine receptor blockers
Mast cell membrane stabilizers
Functional antagonists of allergy mediators.
Glucocorticoid hormones inhibit the development of all stages of allergy. They suppress the formation of immune cells and reduce the production of antibodies, prevent the destruction of mast cells, have an effect opposite to allergy mediators, inhibit exudation and swelling of tissues.
Histamine receptor blockers
Histamine is the main pathophysiological agent, the action of which is associated with an acute allergic reaction that develops as a result of the release of mediators from mast cells and basophils. Histamine itself is used only for diagnostic purposes in the study of the state of the secretory function of the stomach. Histamine antagonists that block H1 and H2 histamine receptors are often used.
(Blockers of H2 histamine receptors - cimetidine, ranitidine, famotidine, etc.).
H1 blockers of histamine receptors have the following effects: antihistamine, sedative-hypnotic, anticholinergic, antiemetic, local anesthetic, etc. Drugs prevent and relieve bronchospasm, stabilize the permeability of the vascular wall, relieve itching, and eliminate spasms of the intestines and uterus caused by histamine. These funds are used for urticaria, allergic rhinitis, hay fever, skin itching, allergic rash, neurodermatitis, dermatitis, eczema, bronchial asthma, and 1st generation drugs for difficulty falling asleep, for premedication before anesthesia, for pain. Undesirable side effects of H1 histamine receptor blockers are associated with their M-anticholinergic properties (dry mouth, constipation and difficulty urinating, tachycardia, increased intraocular pressure) or hypnotic effects: drowsiness, impaired attention, performance, are contraindicated for drivers, operators, etc. ) All drugs of this group are contraindicated in pregnancy, are prescribed with caution in glaucoma, peptic ulcer, kidney and liver diseases.
Drugs of the 1st generation are lipophilic, penetrate the BBB, in addition to histamine receptors, they can block M-cholinergic receptors, alpha-adrenergic receptors, serotonin receptors and exhibit effects: sedative-hypnotic, anticholinergic, antiemetic and anti-sickness. With prolonged use of 2-3 weeks, antihistamine activity (tachyphylaxis) decreases.
Diphenylhydramine (diphenhydramine) - duration of action 3-5 hours, strong sedative effect.
Promethazine (diprazine, pipolfen) - duration of action 6-8 hours, strong sedative effect, enhances the effect of narcotic, analgesic, local anesthetics.
Chloropyramine (suprastin, allergozich) is similar to diprazine, the duration of action is 4-6 hours.
Clemastine (tavegil) - duration of action 6-12 hours, moderate sedative effect, more active than diphenhydramine.
Dimetindine (Fenistil) - has a sedative, anticholinergic effect., The duration of action is 12 hours, undesirable side effects are rare.
Quifenadine (fenkarol) - high activity, almost no sedative, anticholinergic effect, does not irritate.
Mebhydrolin (diazolin) - no sedative effect, moderately active, duration of action up to 24 hours.
Antihistamine drugs 2 generations.
Terfenadine, loratadine (claritin, erolin), astemizole (gistalong), cetirizine (zyrtec, parlazin, allercaps, zodak), ebastine (kestin) are effective, long-acting drugs. Apply 1 time per day, sometimes arrhythmias are possible.
Antihistamine drugs of the 3rd generation.
Fexofenadine (telfast, fexomax), desloratodin (erius) are long-acting highly effective drugs without pronounced side effects. Contraindicated in children under 12 years of age.
Mast cell membrane stabilizers.
They block the intake of calcium ions in mast cells and stabilize the membrane of mast cells and their granules, as a result of which the process of degranulation and the release of an allergy mediator are inhibited.
Sodium cromoglycate (intal) - reduces and relieves asthma attacks. Used prophylactically for the treatment of br. Asthma (but not for stopping attacks) by inhalation using the Spinhaler inhaler. Effect after a few weeks of regular use. It is used to treat allergic rhinitis (nasal spray), conjunctivitis (eye drops).
Ketotifen (zaditen, ketasma) is used to prevent attacks of asthma, with allergic rhinitis, etc. A lasting effect - after 10-12 weeks of daily use, is well tolerated, sometimes drowsiness due to CNS depression.
Nedocromil-sodium (tilet) - an effect for the prevention of inflammatory reactions of allergic origin. Effect - by the end of 1 week of admission.
Functional antagonists of allergy mediators- activate the physiological reaction opposite to that which is caused by this mediator. With spasms of the gastrointestinal tract - M-anticholinergics (atropine, etc.) and myotropic antispasmodics (no-shpa, etc.), with bronchial asthma - beta-adrenergic agonists (salbutamol, etc.), antispasmodics (aminophylline, etc.), with allergic rhinitis in the form of drops, ointments. Alpha-agonists (galazolin, etc.). They have only a temporary symptomatic effect.
