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Hilak forte 30 ml drops for oral administration

Instructions for medical use of the drug Hilak® forte-drops Trade name Hilak® forte-drops International nonproprietary name No Dosage form Drops Composition 100 ml of solution contains active substances: aqueous substrate of metabolic products Escherichia coli DSM 4087 - 24.9481 g, aqueous substrate metabolic products Enterococcus faecalis DSM 4086 - 12.4741 g, aqueous substrate of metabolic products Lactobacillus acidophilus DSM 4149 -12.4741 g, aqueous substrate of metabolic products Lactobacillus helveticus DSM 4138 - 49.8960 g, excipients: sodium phosphate heptahydrate, potassium hydrogen phosphate, lactic acid, concentrated phosphoric acid, potassium sorbate, citric acid monohydrate. Description Transparent, yellowish-brown solution with a caramel odor and sour taste. Pharmacotherapeutic group Antidiarrheal drugs. Antidiarrheal microorganisms. ATC code A07FA Pharmacological properties Pharmacokinetics The composition of the drug Hilak® forte-drops includes numerous metabolic products of gram-positive and gram-negative symbionts of the small and large intestines and therefore kinetic studies of the drug are not possible. Pharmacodynamics Hilak® forte drops is a drug that regulates the balance of intestinal microflora. Disruption of the normal intestinal microflora is possible due to infectious diseases, after antibiotic therapy, radiation, gastric surgery, and also due to unusual nutrition. Due to the content of metabolic products of normal microflora, short-chain volatile fatty acids, Hilak® forte drops promotes the restoration of normal intestinal microflora, stimulates the regeneration of epithelial cells of the intestinal wall, and restores the water-electrolyte balance in the intestinal lumen. The lactic acid and its salts included in the drug restore the normal acidity of the gastrointestinal tract, which creates unfavorable conditions for the life of pathogenic microorganisms. Hilak® forte drops promotes the growth of acidophilic anaerobic intestinal flora, which is antagonistic against salmonella. Against the background of accelerating the development of normal intestinal symbionts, the drug normalizes the natural synthesis of vitamins B6, B12 and K. Indications for use: intestinal dysbiosis due to long-term antibacterial, hormonal, radiation therapy; after an intestinal infection - chronic atrophic gastroenteritis, chronic colitis of various etiologies - dyspepsia and intestinal dysfunction (nausea, flatulence, diarrhea, constipation, traveler's diarrhea, hypo- and anacid conditions, including during pregnancy) - atopic dermatitis, eczema, urticaria - diseases of the gallbladder, biliary tract and liver Method of administration and dosage Before use it is recommended shake the bottle. Hilak® forte drops are diluted in a small amount of liquid (water, tea, juice, compote, except milk) and taken orally before or during meals. Adults and children over 12 years old - 40-60 drops 3 times a day, children from 2 years to 12 years old - 20-40 drops 3 times a day, children from the neonatal period to 2 years - 5-10 drops per 1 kg body weight. After the condition improves, the daily dose can be reduced by half. For persons with heartburn and hyperacidity, the daily dose is recommended to be divided into several doses (5-6 times). The duration of treatment depends on the severity of the clinical picture and averages 30 days. Side effects Hilak® forte drops are well tolerated by patients of any age. Rarely - hypersensitivity reactions of the skin and mucous membranes In isolated cases - mild gastrointestinal disorders Contraindications - individual intolerance to the drug - lactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption Drug interactions Under the influence of antacids, it is possible to neutralize the lactic acid contained in this drug . Special instructions It should be borne in mind that Hilak® forte-drops for diarrhea is prescribed in addition to rehydration therapy. For acute diarrhea accompanied by fever and blood in the stool, you should consult a doctor. Due to the acidic pH value, Hilak® forte drops cause milk to curdle, so it is not recommended to take the drug with milk or dairy products. Pregnancy and lactation Hilak® forte-drops are safe during pregnancy and lactation. Peculiarities of influence on the ability to drive a vehicle or potentially dangerous mechanisms No effect. Overdose No cases of overdose have been reported. Release form and packaging 30 ml and 100 ml are placed in brown glass bottles with a screw-on plastic cap with a protective ring and a dropper stopper. 1 bottle, along with instructions for medical use in the state and Russian languages, is placed in a cardboard box. Storage conditions Store at a temperature not exceeding 25˚C. Keep out of the reach of children! Shelf life: 5 years. Period of use after first opening the bottle is 12 months. Do not use after expiration date. Conditions for dispensing from pharmacies Without a prescription, Germany Owner of the registration certificate "ratiopharm GmbH", Germany Address of the organization that accepts claims from consumers on the quality of products (products) in the territory of the Republic of Kazakhstan "ratiopharm Kazakhstan" LLP, Almaty, Al-Farabi Ave. 19 , BC "Nurly-Tau", 1B, office. 603, tel. (727)3110915, fax: (727)3110734, e-mail

On June 15-16, 2022, the II Russian Forum with international participation “Modern Pediatrics. St. Petersburg - White Nights - 2017", the purpose of which is to inform the Russian pediatric community about modern possibilities for the prevention, diagnosis and treatment of various diseases in children and adolescents, as well as to exchange experience on scientific and practical issues of providing pediatric care in various regions of the Russian Federation. The focus of the forum participants, in particular, was on the issues of drug correction of dysbiotic conditions in children.

In her report, Elena Aleksandrovna Kornienko, head of the department of gastroenterology of FP and DPO (Faculty of Postgraduate and Additional Professional Education) of the St. Petersburg State Pediatric Medical University (SPbSPMU Ministry of Health of the Russian Federation), chief pediatric gastroenterologist of St. Petersburg, outlined the role of drugs of the metabiotic group in the formation of metabiota in the child’s intestines .

Elena Aleksandrovna reported that intestinal microbiota - a set of bacteria and other living microorganisms in the human intestine - plays an important role, performing digestive, immune, bactericidal and other functions. According to modern scientific data, the number of microbes in the intestines exceeds the number of cells in the human body by 10 times. If the bacterial composition of the microbiota is disrupted, a condition called dysbacteriosis, or dysbiosis, can develop.

It is worth noting that dysbiotic conditions can develop gradually, but the presence of pathological processes may be indicated by symptoms such as loose stools, abdominal discomfort, bloating, flatulence and other digestive disorders. Acute diarrhea is closely related to dysbiosis. It is especially common and dangerous in children under 5 years of age [1].

To normalize the intestinal microbiota, two main groups of drugs are traditionally used: probiotics (live bacteria or fungi, which are usually dried to ensure the required shelf life) and metabiotics (their ready-to-use metabolites). Metabiotics differ from probiotics in that while dried probiotics require activation in the intestine, after which they can begin producing metabolites, metabiotics contain ready-made metabolites and do not require additional activation.

A special role in the formation of microflora in the intestine and in the nutrition of the intestinal mucosa is played by bacterial metabolites such as short-chain fatty acids and lactic acid. They, being previously obtained from four types of beneficial bacteria (Lactobacillus helveticus, Escherichia coli, Lactobacillus acidophilus, Enterococcus faecalis), are contained in the German metabiotic drug “Hilak Forte”. Unlike probiotics, the effect of Hilak Forte is due to live bacteria, which tend to be destroyed in the acidic environment of the stomach, under the influence of bile and digestive enzymes, as well as when used together with antibiotics. The drug "Hilak Forte", whose action is due to ready-made metabolites and not live bacteria, remains effective when taken with antibiotics.

“Hilak Forte” is one of the drugs of choice in pediatric gastroenterology and has been included in the Russian Industry Standard “Patient Management Protocol” for more than 14 years. Intestinal dysbiosis" [2]. The drug is used to correct a number of conditions: disturbances in the physiological flora of the small and large intestines (during and after treatment with antibiotics or sulfonamides, radiation therapy); diarrhea, flatulence, constipation; gastroenteritis, colitis; gastrointestinal disorders caused by climate change; salmonellosis in the convalescent stage (including in infants) [3].

The drug can be used in children from birth. Until recently, “Hilak Forte” was produced in the form of drops, but now it is presented on the Russian market in a new convenient sachet form with adult and pediatric dosages.

Teva
in the world
Teva Pharmaceutical Industries Ltd. – one of the leaders in the global pharmaceutical industry. Headquartered in Israel, the company provides high-quality, patient-focused solutions every day to millions of people in need of treatment around the world.

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Teva in Russia

Teva's activities in Russia can serve as an example of the care and responsibility with which the company treats all eighty markets in which it is present. This attitude is a key part of Teva's mission to provide quality, affordable healthcare products to patients around the world. Teva has included the Russian market in its list of priorities for further investments.

Having started operating in Russia in 1995, Teva is today one of the largest pharmaceutical companies in the Russian market with a portfolio of more than 300 products. The company's turnover in Russia has grown more than tenfold over the past five years. The Russian division of Teva currently employs about 1,350 employees.

In October 2014, as part of the implementation of the international investment strategy, Teva LLC opened a pharmaceutical plant in Yaroslavl. The plant, whose capacity allows it to produce up to two billion tablets per year, will supply its products to the markets of Russia and neighboring countries.

For more than 20 years of presence on the Russian market, Teva has served its main goal - ensuring the health, safety and high quality of life of patients in Russia. www.teva.ru

Links

1 Media Center. Diarrhea. Newsletter No. 330. World Health Organization website. https://www.who.int/mediacentre/factsheets/fs330/ru/. Published April 2013. Retrieved June 19, 2017.

2 Order of the Ministry of Health of Russia dated June 9, 2003 No. 231 “On approval of the industry standard “Protocol for the management of patients. Intestinal dysbiosis" (OST 91500.11.0004-2003).

3 Instructions for use of the medicinal product for medical use Hilak forte P N014917/01.

Use of Hilak forte in children

Hilak forte is immediately* ready to act, not after 8-10 hours 2

Restoring normal microflora is often one of the optimal solutions in the treatment of diarrhea and functional constipation. In the category of drugs for normalizing microflora, there are drugs with different mechanisms of action: probiotics, prebiotics, metabiotics. Prebiotics are a breeding ground for bacteria living in the intestines. Probiotics are live microorganisms taken orally that replenish the deficiency of beneficial bacteria, such as bifidobacteria and lactobacilli. Dried probiotics take 8–10 hours to become active2 and can be destroyed by the acidic environment of the stomach, bile, or digestive enzymes. With diarrhea in children, the transit of intestinal contents is accelerated (about 5 hours)5, and therefore it may happen that the probiotic is eliminated from the body before it can exert its beneficial effect. 2-3

The German drug Hilak Forte does not contain living microorganisms and already consists of their waste products; it does not require time to enter an active state and is immediately* ready to act.

*"Immediately" refers to "ready". It is understood that when taking Hilak Forte, the capsule does not dissolve, since the drug is available in liquid form and already contains ready-made metabolites that are active immediately after administration, unlike dry bacteria in capsules, which require time to produce them. 2 Adzhigaitkanova S.K. RMJ. Diseases of the digestive system. 2007(2):73-76.

Hilak forte is indicated for a number of conditions in children1:

diarrhea, flatulence, constipation;
allergic skin diseases (urticaria, endogenously caused by chronic eczema);
colitis, gastroenteritis;
disruption of the physiological flora of the small and large intestines (during and after treatment with antibiotics or sulfonamides);
digestive insufficiency syndrome, dyspepsia;
salmonellosis in the convalescence stage (including in infants);
disorders of the gastrointestinal tract caused by climate change;
hypo- and anacid states.

Use of Hilak forte in children from birth

Hilak forte drops - individual dosages for children of different ages:

Age	Dosage per appointment
Infants (up to 1 year1)	15-30 drops
Children	20-30 drops

It is convenient to give Hilak Forte drops to a child by adding them to water, juice, compote or tea1:

Hilak forte	Capsules	Powders
Ready to use	Capsule needs to be opened	Ready to use
Soluble in water	Sediment	Sediment
Does not contain bacteria	Impact on microorganisms Air Light Stomach acid	Impact on microorganisms Air Light Stomach acid

Hilak forte	Ready to use	Soluble in water	Does not contain bacteria
Capsules	Capsule needs to be opened	Sediment	Impact on microorganisms Air Light Stomach acid
Powders	Ready to use	Sediment	Impact on microorganisms Air Light Stomach acid