Last updated description by manufacturer 15.07.2005
Filterable list
Active substance:
ATX
Pharmacological group
Nosological classification (ICD-10)
Composition and form of release
in dark glass jars, 10 pcs. or in a contour acheikova packing 2, 4, 5 or 10 pcs .; in a pack of cardboard 1 can or package.
Description of the dosage form
Hard gelatin capsules No. 0, white body, brown cap. The contents of the capsules are powder and granules of white or white with a yellowish sheen.
pharmachologic effect
pharmachologic effect- complexing, detoxifying.It has a detoxifying effect (including in relation to ethanol half-life products). It is used as an antidote for poisoning with arsenic compounds and heavy metal salts.
Pharmacodynamics
Forms water-soluble complexes with blockers of sulfhydryl groups (with poisons in the blood and tissues, ethanol half-life products), accelerating their excretion from the body. Strong binding to blockers of sulfhydryl groups and the rapid elimination of the resulting complexes prevents the binding of thiol groups of enzymes, which contributes to the restoration of their activity - as a result of which the symptoms of poisoning are weakened or completely eliminated. Increases the excretion of certain cations (especially copper and zinc) from metal-containing cell enzymes. In patients with diabetic polyneuropathy, it helps to reduce pain, improve the function of the peripheral nervous system, and normalize capillary permeability.
Pharmacokinetics
After oral administration, C max in the blood is reached after 1.5 hours and is in the range of 90-140 μg / ml (on average, 114.62 ± 7.53 μg / ml). The average retention time of the drug in the body is 9-11 hours (on average, 10.16 ± 0.39 hours). T 1/2 - 7.5 ± 0.46 hours. The apparent stationary volume of distribution is 166.5 ml / kg. Does not accumulate in the body.
Indications for R-IKS 1
Alcohol withdrawal syndrome, chronic alcoholism (complex therapy). Acute and chronic poisoning with organic and inorganic compounds of arsenic, mercury, gold, chromium, cadmium, cobalt, copper, zinc, nickel, bismuth, antimony; intoxication with cardiac glycosides; hepatocerebral degeneration (Wilson-Konovalov disease); diabetic polyneuropathy.
Contraindications
Hypersensitivity, severe diseases of the hepatobiliary system, arterial hypertension.
Side effects
Possible nausea, dizziness, tachycardia, pallor of the skin (with prolonged use in high doses).
Interaction
Pharmaceutically incompatible with preparations containing heavy metals, as well as with alkalis (rapidly decomposes).
Method of administration and dosage
Inside 1/2 hour before meals with a little water.
Alcohol withdrawal syndrome, poisoning with arsenic compounds and heavy metal salts: 1-2 caps. at the reception, if necessary, the dose can be increased to 3 caps. (750 mg) per day in divided doses. Treatment is carried out until the symptoms of intoxication stop.
Chronic alcoholism: 2 caps. 2 times a day as part of a course of complex therapy.
Diabetic polyneuropathy: 1 caps. a day for 10 days.
Overdose
Symptoms: shortness of breath, hyperkinesis, lethargy, lethargy, stunnedness, short-term convulsions (occur when the recommended therapeutic dose is exceeded by more than 10 times).
Treatment: gastric lavage, intake of activated charcoal, laxatives, symptomatic therapy.
special instructions
In the treatment of acute poisoning, it is necessary to carry out additional therapeutic measures (gastric lavage, oxygen therapy, administration of dextrose, etc.).
Storage conditions of the drug R-IKS 1
In a dry, dark place at a temperature not exceeding 25 ° C.Keep out of the reach of children.
Shelf life of the drug R-IKS 1
2 years.Do not use after the expiration date printed on the package.
Synonyms for nosological groups
| ICD-10 heading | Synonyms of diseases according to ICD-10 |
|---|---|
| E83.0 Disorders of copper metabolism | Wilson-Westphal-Konovalov disease |
| Wilson-Konovalov disease | |
| Wilson's disease | |
| Wilson-Konovalov syndrome | |
| Hepatolenticular degeneration | |
| Hepatocerebral dystrophy | |
| Hepatocerebral dystrophy | |
| Copper toxicosis congenital | |
| Menkes disease | |
| F10.2 Alcohol dependence syndrome | Alcoholism |
| Alcohol addiction | |
| Dipsomania | |
| Alcohol addiction | |
| Drunkenness | |
| Drunken state | |
| Alcohol abuse | |
| Ideatory disorder in alcoholism | |
| Quarter binge | |
| Compulsive alcohol cravings | |
| Neurotic symptoms in alcoholism | |
| Pathological craving for alcohol | |
| Psychoorganic syndrome in chronic alcoholism | |
| Decreased craving for alcohol | |
| Chronic alcoholism | |
| F10.3 Withdrawal state | Withdrawal alcohol syndrome |
| Withdrawal symptoms | |
| Withdrawal syndrome with alcoholism | |
| Withdrawal symptoms | |
| Alcoholic withdrawal | |
| Alcohol withdrawal | |
| Alcohol withdrawal state | |
| Alcohol withdrawal syndrome | |
| Post-abstinence disorder | |
| Post-withdrawal state | |
| Hangover syndrome | |
| Withdrawal syndrome | |
| Alcohol withdrawal syndrome | |
| Alcohol withdrawal syndrome | |
| Withdrawal state | |
| G63.2 Diabetic polyneuropathy (E10-E14 + with common fourth character. 4) | Pain syndrome in diabetic neuropathy |
| Pain in diabetic neuropathy | |
| Pain in diabetic polyneuropathy | |
| Diabetic polyneuropathy | |
| Diabetic neuropathy | |
| Diabetic neuropathic ulcer of the lower extremities | |
| Diabetic neuropathy | |
| Diabetic polyneuropathy | |
| Diabetic polyneuritis | |
| Diabetic neuropathy | |
| Peripheral diabetic polyneuropathy | |
| Diabetic polyneuropathy | |
| Sensory-motor diabetic polyneuropathy | |
| T46.0 Poisoning with cardiac glycosides and drugs of similar action | Arrhythmia on the background of digitalis intoxication |
| Glycosidic intoxication | |
| Digitalis arrhythmia | |
| Digitalis intoxication | |
| Cardiac glycoside intoxication | |
| Intoxication with cardiac glycosides and diuretics | |
| Poisoning with digitalis drugs | |
| Overdose or poisoning with digitalis glycosides | |
| T56 Toxic effects of metals | Manganese intoxication |
| Intoxication with metals and their compounds | |
| T56.1 Toxic effects of mercury and mercury compounds | Mercury intoxication |
| Chronic mercury poisoning | |
| T56.3 Toxic effects of cadmium and its compounds | Cadmium intoxication |
| Intoxication with cadmium compounds | |
| Poisoning with cadmium compounds | |
| T56.4 Toxic effect of copper and its compounds | Copper intoxication |
| T56.5 Toxic effects of zinc and zinc compounds | Zinc intoxication |
| Foundry Fever | |
| Poisoning with zinc compounds | |
| Zinc poisoning | |
| Zinc fever | |
| T56.8 Toxic effects of other metals | Magnesium and its compounds |
| Cobalt poisoning | |
| Plutonium poisoning | |
| Poisoning with compounds of gold | |
| Poisoning with magnesium salts | |
| Cesium poisoning | |
| Cerium poisoning | |
| Chronic nickel intoxication | |
| T57.0 Toxic effect of arsenic and its compounds | Arsenic intoxication |
| Arsenic poisoning | |
| Poisoning with arsenic compounds |
With this article, we begin a series of publications in which we will discuss the most relevant and debatable points (sections) related to the dispensing of medicines; let's take a closer look at the principles of responsible self-medication; we will touch upon various aspects of the use of over-the-counter drugs (including those related to possible abuse and non-medical use); Let us use international experience to acquaint the reader with the modern disposition of the drug dispensing regime in the world based on the materials of the most authoritative international sources (AESGP / WSMI *). This is especially prompted by the proposals recently submitted for public discussion regarding the next changes to (see. ).
It is symptomatic that the English abbreviation "OTC", derived from "Over The Counter" (out of account), completely coincides with the Russian abbreviation "OTC", if you deduce it from "Responsible Self-Treatment". What is the OTC concept, why was it invented and "what is it used for?" To answer these questions, it is logical to consider the OTC concept both from a historical point of view and from the standpoint of today. However, if we extend the range of abbreviated analogies, then a direct bridge emerges from here to another cornerstone concept, proclaimed by WHO more than three decades ago - the concept of EML (essential medicines or essential medicines). In this regard, it is not a sin to recall that the alpha and omega of this concept, along with the ubiquitous efficacy and safety of drugs, are their availability (both physical and economic). According to the WHO definition (WHO policy perspectives on. The selection of essential medicines. Medicines. Geneva: World Health Organization; 2002; www.who.int/medicines):
“The main drugs are those that meet the priority needs of the population in medical care. The selection of EMLs is carried out in strict accordance with the needs of the healthcare system, as well as evidence of the effectiveness, safety and economic feasibility of their use. By definition, the OLS should be available:
- at any time and in sufficient quantities;
- in appropriate dosage forms;
- accompanied by undoubtedly high-quality and adequate information;
- at a price affordable for the patient and society.
The EML concept assumes a flexible implementation mechanism and the ability to adapt to different circumstances; the decision of the question of which drugs should be considered as essential is the full prerogative of each state and remains in the area of its own responsibility. "
1. Conceptual-definitive slice
Self-medication, as defined by the WSMI, is the treatment of common (trivial) health problems with drugs specifically designed and labeled for non-medical use, approved to be effective and safe for such use. Self-medication, which is also called OTC or OTC drugs, unlike prescription drugs (Rx drugs), are available for purchase in pharmacies without presenting a doctor's prescription. In some countries, they are also sold in supermarkets and other retail outlets.
Every day and everywhere, millions of consumers resort to the help of free vacation funds to solve common and minor health problems, the diagnosis and treatment of which does not require the intervention of a doctor. This happens for a number of reasons, and above all because this way of treatment is easier for patients, it helps them save money and time. At the same time, the task and area of responsibility of the state, healthcare workers and suppliers of OTC drugs is to create all the necessary prerequisites for self-medication to be RESPONSIBLE (that is, it does not harm the consumer, but on the contrary, benefits his health).
There is good reason to believe that consumers can and do self-medicate responsibly. This statement is also supported by the fact that OTC drugs enjoy significant recognition and demand among consumers. In general, they use OTC drugs appropriately, carefully and carefully, after reading the package insert for medical use. These facts are documented by consumer practice in many countries of Europe, Asia and America. Despite some differences in the prevalence of the nosologies under consideration and the measures taken to combat them, people around the world generally respond in the same way to emerging "routine" health problems. In about half of the cases, patients let the disease move its own way, but in a quarter of cases, they resort to over-the-counter drugs. Research by WSMI and other reputable sources suggests that patients are generally cautious and considerate when choosing over-the-counter drugs. They read the labels and most often buy the drug in an amount that does not exceed the duration of the maximum course of treatment indicated on the package. There are cases when consumers take an even more active part in medical self-care, including self-medication. For example, 59% of those surveyed in the United States answered that today they are more ready to treat their disease on their own than a year ago. 73% would prefer self-medication at home rather than going to a doctor, and 6 out of 10 are confident that in the future they will give more preference to self-medication. The explosion of medical information that has occurred in recent years due to technological progress, which has dramatically improved access to information that is suitable and useful for end users, coincides with the interests of patients. Consumers today have a large arsenal of tools to play an active role in their own care — and they use these tools. It is estimated that about 65% of people who use the Internet within 1 year visit medical content sites. Finally, the aging of the population around the world, the growing interest in disease prevention, the desire of patients for a quality and long life - all these are trends characteristic of the development of modern society. And one such typical trend is the growing importance of responsible self-medication in the healthcare system.
Self-medication is a lifelong behavioral habit, an internal stereotype, a characteristic feature of an individual culture. This is an action that a person takes in order to maintain his own health and the health of his family members and to overcome short or long-term pathological conditions. He does this based on his own knowledge and available external information, and, if necessary, in interaction with medical and social workers. Self-medication includes:
- healthy lifestyle choices in particular physical activity and healthy eating, which promote good health and prevent the development of disease;
- ensuring the responsible use of any medication(both prescription and over-the-counter);
- self-recognition of symptoms, which includes the assessment and interpretation of pathological manifestations, if necessary, in interaction with a medical professional (not necessarily a doctor);
- introspection, which involves comparing signs and symptoms for deterioration or improvement;
- self-help, which includes the patient's ability to cope with the manifestations of the disease - either on their own, or in interaction with health professionals or others with similar medical problems.
People with an active self-medication stance are able to confidently make informed decisions about their health, without necessarily going to the doctor. Self-medication brings great benefits to society by increasing patients' self-esteem, improving their well-being and health status, increasing life expectancy, reducing the amount of medical care provided and thereby saving health care resources. Countries that strongly encourage self-medication can count on healthier populations - this makes it possible to reallocate scarce resources to priority sectors. Self-medication can play a leading role in preventing global epidemics of non-communicable chronic diseases, in particular, cardiovascular and oncological pathology, diabetes mellitus, etc.
At the same time, people should receive information, knowledge and other necessary tools that allow them to be more capable of protecting their own health and more confident in medical self-care, to make responsible decisions to effectively eliminate their medical problems. An important role in the development of self-medication belongs to medical workers, and not only to doctors and pharmacists.
2. Socio-economic cut
There is hardly a country in the world that is happy with its health care budget. The US is living at ease, and even there, the government is initiating large-scale and highly resonant reforms aimed at improving health care and at the same time optimizing its budgeting. We emphasize that the OTC concept is aimed at increasing not only the physical, but also the economic availability of medicines. This concept has a deep social background, which once again makes it related to the OLS concept. And the transfer (switch) of a product from the Rx group to the OTC niche is carried out primarily with the aim of making it more accessible to the consumer. With the help of over-the-counter drugs, the state actually shifts part of its costs and obligations to the patient onto the shoulders of pharmaceutical manufacturers. The latter are given the opportunity to independently carry out the entire range of relevant tasks, to determine by themselves which drugs, to whom and for what pathology are indicated, to inform consumers about this, as a result, they are also responsible for this to the patient. This is beneficial both for the state, which relieves the health care budget of an additional burden, and for manufacturers, who get the opportunity to have direct contact with the consumer, and for patients who can solve their not serious, but annoying medical problem, whether it is a cold or heartburn, fungus or alopecia, on their own ( without going to the doctor) and at an affordable price (which to the most significant extent favorably distinguishes the vast majority of OTC drugs from their prescription counterparts: after all, the cost of OTC products is often several times less than that of prescription drugs).
Today, the Ukrainian pharmaceutical market is almost halved between prescription and OTC drugs in monetary terms, and in real terms, OTC drugs occupy almost 70% of the market pie (according to the analytical system of the market research "Pharmstandard" / "PharmXplorer" by "Proxima Research"). It is the high physical and price availability of OTC products that allowed them, which at the same time have a significant social function, to achieve such a ratio. But, alas and ah, our country is the only one in Europe that does not have a system of reimbursement of the cost of medicines (reimbursement), that is: the provision of medicines to patients is the work of the patients themselves. And even more so, as for no one else, the factor of affordability of the necessary drug is important for us. And as for the outraged exclamations that the share of non-prescription drugs on the Ukrainian market is already too large, they say (leaving the little finger), "fi, some kind of uncivilized profile of your drug use" (and where does it come from, civilized? !), - so what's wrong with that if the state itself does not undertake to provide the population with medication? Since one way or another the patient is to pay out of his own pocket, it would be more logical to hear exclamations about the need to compensate the population for the lack of a reimbursement system. And if the state (not realizing its own benefit) seeks to regulate the form of vacation, again stepping on the corn of its distressed patient, then ask the state a question (quite rhetorically, however): how will the patient be compensated for this, is money provided for this?
The OTC segment is a real layer of medical care, in which the state does not invest anything, society spends nothing, and the patient receives additional financial, medical and social preferences. However, in our country, the very ideology of drug dispensing is turned on completely different rails: in our country it is designed to determine the actual possibility of a vacation (and that is purely speculative: in fact, every visitor to a Ukrainian pharmacy will buy what he wants without a prescription, or rather, maybe), in the world, this is a purely economic category and boils down to who will pay for the purchased drug: the state, the patient, or in a certain proportion. The activities of the health insurance and reimbursement systems are based on this, they are carefully verified on the basis of complex criteria and the corresponding lists of drugs are created (positive, negative, etc.). In our country, removing a drug from the OTC segment means limiting the patient's ability to self-medicate. But did the state provide money for this? No, on this score it is silent. Is society ready to take responsibility for this? No, budgets are not released. As a result, more patients will be left without qualified medical care. Precisely qualified! Since the replacement of the “grandmother's” segment with OTC products with proven efficacy and safety, extensive experience in clinical use is a blessing for the patient. To be treated with terbinafine instead of Teymurov's paste is a blessing for the patient (not to mention saving money). So what to regulate, I would like to ask a proactive official, - since the state does not participate in the process with the ruble, then on the contrary, it liberalizes: it will not require any investments and will save you from many medical and social problems.
Let us finish the introductory article of this cycle with a number of thematic quotes from policy documents of leading international organizations.
“Health systems around the world are under great pressure to deal with if they continue to focus more on the disease than on the patient. It is necessary to involve in the process of providing medical care the individual of the patient who is committed to his treatment, is capable of the dynamics of behavioral positions and the provision of self-help. "
International Union of Patients' Organizations. Declaration of patient-centered health care (2006) (The International Alliance of Patients' Organizations. Declaration on patient-centered Healthcare. February 2006.).
“Everyone has the right to health education which This will help him / her make informed choices about his / her own health and determine appropriate medical care. Education should include information about healthy lifestyles and methods of preventing and early recognition of diseases. Emphasis is placed on the importance of each individual's personal responsibility for his / her own health. Doctors are obliged to take an active part in educational activities ”.
World Medical Association. Patient Rights Declaration (1981, 2005 update) (World Medical Association. Declaration on the Rights of the Patient. 1981, revised 2005).
“Nowadays, people are faced with an urgent need to take more responsibility for their own health and receive the maximum possible information from expert sources. - to enable them to accept correct medical decisions. (…) Pharmacists have a key role to play in providing patients with care, advice and information about medicines available for self-medication. "
International Pharmaceutical Federation. AESGP * and WSMI ** Joint Statement (1999) ( The International Federation of Pharmacists. Joint Statement by FIP & WSMI, 1999).
To be continued…
F. Snegirev
* AESGP (European Association of OTC Medicines Manufacturers - European Self-medication Industry; www.aesgp.be); ** WSMI (World Federation of OTC Pharmaceutical Manufacturers - World Self-medication Industry; www.wsmi.org)
Sex is an integral part of every man's healthy life. But for various reasons, the reproductive system often fails. This can be due to both psychological and organic (physiological) reasons. The modern rhythm of life does not allow you to relax even for a minute. Physical and mental stress, a polluted environment, disorder, lack of sufficient means for life - the list of factors that can cause impotence is endless. But you shouldn't despair. Doctors have developed a number of drugs that eliminate the problem of erectile dysfunction.
What drugs are better for improving potency - generics or originals?
Choosing medicines to improve potency, many ask the question: "which medicines to improve potency are better - generics or originals?" To answer this question, you need to understand what a "generic" is. This term denotes medicines, the name of which is not protected by patent law. In terms of composition and effectiveness, they are similar to those of patented drugs. In fact, these are exactly the same drugs. But in fact, they have a difference - the price. This is the only parameter by which “original” drugs differ from generics.
RX Tadalafil: a combination of quality and efficiency
RX Tadalafil is a new development of Indian pharmacologists. It is an exact copy (analogue) of "Cialis". Its popularity is due to its high efficiency, long period of action. Sunrise Remedies developed this drug several years after the introduction of Tadalafil on the market. The Indian concern managed to create an effective medicine to improve potency, which differs from the "original" only in a more affordable price.
Indications
Tablets "RH Tadalafil" are prescribed for the treatment of erectile dysfunction, weakened erection, benign prostatic hyperplasia. The drug does not protect against unplanned pregnancy and sexually transmitted diseases.
Composition
The active ingredient in Generic Cialis 10 mg is Tadalafil. It is a selective inhibitor of the cGMP-specific enzyme phosphodiesterase (PDE) type 5. After appearing on the market, Tadalafil began to actively displace Viagra and Levitra. The high popularity of the drug is due to a rather mild effect on the body, good tolerance, and a long period of action.
Operating principle
The principle of action of Tadalafil and other PDE-5 inhibitors is based on relaxing the smooth muscles of the penis and increasing the amount of cGMP in the blood. Together with this, the active substance has a vasodilating effect. As a result, blood flow to the penis increases, leading to a lasting erection. After the onset of orgasm, the reverse process begins. An erection after using the RX Tadalafil tablet is natural. Therefore, the excitement of the reproductive system is possible only in the presence of a sexual partner.
Benefits of the drug "Generic Cialis Tadalafil 10 mg"
The drug "Generic Cialis Tadalafil 10 mg" has many advantages. We list only the main ones:
- A new generation formula. The medicine is an absolute copy (analogue) of Cialis. The new formula is distinguished by increased safety, almost complete absence of side effects, and a long-lasting effect. Previously created drugs had a rather limited period of action of 4-6 hours. Tadalafil allows you to enjoy intense sex for up to 36 hours.
- Alcohol compatibility. For many men and women, drinking wine before intimacy is the norm. But the properties of other drugs do not allow drinking alcohol. During clinical trials, it was found that Tadalafil does not interact with alcohol. Therefore, after taking the pill, even strong drinks are allowed.
- The optimal dose. The content of the active ingredient "Generic Cialis" in the amount of 10 mg is optimal. If necessary, it can be reduced to 5 mg (½ tablet) or increased to 20 mg (2 tablets).
Another important advantage of the drug is its low price.
Tablets "generic Tadalafil 10 mg": instructions for use
Tablets "Generic Tadalafil 10 mg" are taken 1 piece 25-40 minutes before the scheduled sexual contact. For people who are first faced with drugs to improve potency, it is recommended to start with ½ tablet (5 mg). The maximum dose per day is 20 mg. The period of action is 24-36 hours. For many men, the effect lasts up to 48 hours.
Tadalafil is insoluble in alcohol. Therefore, while taking RX Tadalafil, it is allowed to consume low alcohol and spirits in small quantities. Abundant and fatty food does not affect the rate of appearance of the effect.
Contraindications
"Generic Cialis" is contraindicated for women and men under 18 years of age, as well as for:
- liver failure;
- tendency to priapism;
- severe atherosclerosis;
- Alzheimer's disease;
- spinal injury.
In case of individual intolerance to Tadalafil, it is recommended to take no more than 5-10 mg of the active ingredient per day.
Side effects
Thanks to the updated formula and the use of modern production methods, side effects after taking Tadalafil are less and less common. Most often they manifest themselves in the form of dyspepsia and headache. Myalgia, back pain, facial flushing, nasal congestion are very rare. There were also one-off cases of dizziness and increased photosensitivity. The listed undesirable effects are temporary. They usually disappear within a few hours.
Compatibility
Do not combine RX Tadalafil with taking nitrogen donors, anthocides, CYP3A4 inhibitors, alpha-blockers, HIV protease inhibitors. If you are taking any medication, it is best to consult your doctor first.
Overdose
During clinical trials of Cialis, it was found that exceeding the dose of Tadalafil several times does not lead to serious consequences. But the likelihood of occurrence and the strength of side effects increases dramatically. Doctors warn that overdose can be life-threatening.
Release form
RX Tadalafil comes in yellow egg-shaped tablets. They are hermetically packed in blisters of 10 pcs. Each pill contains 10 mg of Tadalafil. Manufacturer - Sunrise Remedies.
Storage conditions
The tablets should be stored in a dry place, protected from pets and children. Storage temperature should not exceed 28 ° C. It is forbidden to use the medicine later than the period indicated on the blister.
Where can you buy RX Tadalafil tablets?
You can buy RX Tadalafil tablets in our online store. We offer a medicine to improve potency cheaply, with delivery. Russian Post will deliver "Generic Cialis 10 mg" to any region of the Russian Federation within a maximum of 14 days. In Moscow and St. Petersburg "RH Tadalafil" can be received by courier.
The drug "Generic Cialis": reviews
For the drug "Generic Cialis" leave your comments on this page. Your opinion on the drug will help other buyers.
Kirill, Novorossiysk
Personally, I like Cialis 10mg the most. This dose with the head is enough for an erection, and the effect lasts for a very long time.
Goga, Krasnodar
This is the first potency medicine I have tried. It suits me perfectly. The tablets are enough for three days. So far, at least I have not noticed any side effects.
Janssen Biotech is planning a phase 1 clinical trial of a drug that its partners at Ionis Pharmaceuticals have developed to treat gastrointestinal immune disorders.
Under the cooperation agreement, Ionis Pharmaceuticals received $ 5 million for what they were able to promote IONIS-JBI 1-2.5 Rx to the stage of clinical research.
Janssen Biotech is responsible for obtaining the IONIS-JBI 1-2.5 Rx regulatory approval for worldwide use and commercialization of the drug.
Ionis Pharmaceuticals can receive an additional $ 585 million for the use of the license for its development. The company will also receive a percentage of IONIS-JBI 1-2.5 Rx sales.
Ionis Pharmaceuticals specializes in RNA-targeted therapies for patients with unmet medical needs, including gastrointestinal and inflammatory bowel disease.
Ionis Pharmaceuticals used its proprietary antisense technology to develop IONIS-JBI 1-2.5 Rx.
Antisense therapy is a method of treatment based on turning off / stopping the synthesis of a protein involved in the development of a disease by inhibiting the translation of its messenger RNA using short nucleotide sequences complementary to it (antisense oligonucleotides).
IONIS-JBI 1-2.5 Rx is the first oral antisense therapy for gastrointestinal immune disorders that Ionis Pharmaceuticals has been able to promote into clinical trials.
We are pleased with the results of our collaboration with Janssen Biotech. It took us 2 years to start clinical trials IONIS-JBI 1-2.5 Rx.
Our collaboration with Janssen Biotech combines the broad applicability of our antisense therapy with those associated with immune autoaggression.
C. Frank Bennett, Senior Vice President, Ionis Pharmaceuticals
In June 2017, Janssen Biotech announced a partnership to develop, manufacture and market a new drug for ulcerative colitis (UC) and Crohn's disease (CD).
Protagonist Therapeutics are promoting PTG-200, an IL-23 receptor antagonist, as a new therapy for IBD. Interactions between the receptor and the IL-23 protein generate cytokines that contribute to the inflammation seen in NUC and CD.
The FDA has approved Protagonist Therapeutics' application for the development of PTG-200, giving approval to conduct clinical trials of the drug.
Protagonist Therapeutics gave a presentation at the conference Digestive Disease Week in Chicago in May 2017, which showed that PTG-200 ameliorated the symptoms of inflammatory bowel disease in experimental mice.
Digital is a relatively innovative channel for promoting prescription drugs in the Russian market. If for OTC products, this tool was active in the last decade, then for prescription pharmaceuticals, due to the peculiarities of the promoted products, this method is still in its infancy as a tool for influencing sales.
The difficulty of promoting prescription drugs lies in the fact that a number of bills have been adopted within the Russian Federation that restrict the activities of pharmaceutical companies. The legislation of the Russian Federation strictly regulates advertising for prescription drugs, the "Federal Law" On Advertising "dated March 13, 2006 No. 38-F3 (hereinafter - the Law" On Advertising ") establishes a closed list of exceptions that allow advertising of prescription drugs and drugs, Internet sites this list is not included. Thus, advertising of prescription drugs and drugs on Internet sites violates the Law "On Advertising". A conference broadcast on the Internet, during which prescription drugs or drugs are mentioned, if this information is not intended to draw attention to a pharmaceutical company or a specific product and promote this company or product on the market, is not an advertisement.
In the event of a conference broadcast via the Internet, during which a company logo and / or a trademark that individualizes a prescription drug was placed in the audience, such information may be considered advertising. "
However, it was the draft law of 21.11.2011 N2 323-FZ "On the basics of protecting the health of citizens in the Russian Federation", which characterizes the interaction of medical practitioners with pharmaceutical companies, regulated at the state level, forced to actively master other sales tools, since it was he who regulated the work of medical workers and pharmaceutical companies. The law introduced new rules, doctors are not allowed to accept gifts, money from pharmaceutical companies, to conclude agreements with pharmaceutical companies on the prescription or recommendation of drugs to patients, to receive samples of drugs from pharmaceutical companies to hand over to patients.
As a result, it is not surprising that now we see active and rapid growth in this direction of sales. Whole departments and many positions appear in companies that will be engaged in marketing through the digital channel. For example, now in many companies there are specialists such as Digital Marketing Manager or Digital Project Manager who can deal with the promotion of either OTC or Rx drugs. Accordingly, managers and assistants appear, but projects are more often given to specialized advertising agencies for implementation.
Examples of using digital tools to promote prescription drugs:
- Internal Internet portals for doctors and pharmacists and other professionals, these sites will not allow third-party users to work with them.
- On-line training for doctors on drugs. Their questioning and collection of information, both on training and on drugs.
- Promotional skype conferences that allow you to communicate with KOLs and other specialists on digging drugs and general issues without leaving your region.
- Specialized sites on nosologies and problems, in which certain drugs are unobtrusively discussed.
- Forums for discussion of drugs and companies, up to representatives of companies with which doctors and pharmacists now work.
- Personal mailings.
- Social networks for doctors and pharmacists.
All these tools will allow you to influence the sales and branding of companies, through doctors and pharmacists, to end consumers.
In addition to the use of Internet resources, a new position is now being formed in pharmaceutical companies, which is called the "Remote Visits Coordinator". These are specialists who are engaged in online information work with healthcare facilities, pharmacies, private and public medical institutions, to inform and maintain the knowledge of doctors and pharmacists on the company's drugs. Ideally, these are remote “visits” of medical representatives. All this happens via skype, telephony, and telekols.
Now drug manufacturers are actively modifying promotion tools and reorienting themselves to the rapidly developing market of Internet resources, which allows pharmaceutical companies to build a new level of communications.
Recruiting company AVICONN
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