Augmeclav powder for oral suspension (400mg+57mg)/5ml №1

Name:
Augmeklav. Release form Powder for suspension for oral administration. Dosage 200 mg + 28.5 mg / 5 ml, Pack quantity: 1 pc. ProducerPharmtekhnologiya OOO. MHNA moxicillin + clavulanic acid. FTG Antibiotic, semi-synthetic penicillin + beta-lactamase inhibitor.
Description:
Powder of white or almost white color with a characteristic smell. When diluted, an almost white suspension with a characteristic odor is formed, with possible white or almost white inclusions. On standing, the suspension slowly forms an almost white precipitate. Composition 5 ml of suspension contain as active ingredients: 200 mg of amoxicillin trihydrate (in terms of amoxicillin) and 28.5 mg of potassium clavulanate diluted with colloidal silicon dioxide (1:1) (in terms of clavulanic acid) or 400 mg of amoxicillin trihydrate (in terms of clavulanic acid) or 400 mg of amoxicillin trihydrate (in terms of in terms of amoxicillin) and 57 mg of potassium clavulanate diluted with colloidal silicon dioxide (1:1) (in terms of clavulanic acid) Excipients: hypromellose, anhydrous colloidal silicon dioxide, xanthine gum, aspartame, orange flavor, raspberry flavor , succinic acid, silicon dioxide. Pharmacotherapeutic group Antibacterial agents for systemic use. Beta-lactam antibiotics, penicillins. Combinations of penicillins, including beta-lactamase inhibitors. ATX code: J01CR02. Pharmacological properties Amoxicillin is a broad-spectrum semi-synthetic penicillin (beta-lactam antibiotic) that inhibits enzymes involved in the synthesis of peptidoglycan in bacteria. Peptidoglycan is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to a weakening of the strength of the cell wall, which usually results in the death of the bacterium. Amoxicillin can be destroyed by beta-lactamases, enzymes that are produced by antibiotic-resistant bacteria. Clavulanic acid inactivates some bacterial beta-lactamases, thereby preventing the breakdown of amoxicillin. By itself, clavulanic acid does not have a clinically significant antibacterial effect. Thus, the combination of amoxicillin + clavulanic acid is effective against many microorganisms that produce beta-lactamase and which are resistant to the action of amoxicillin when used alone. Bacterial resistance may be due not only to the production of beta-lactamases, but also to other mechanisms. If resistance is not due to beta-lactamases, AUGMECLAVE will not have the desired effect. The prevalence of bacterial resistance can vary by geographic location and over time for certain bacterial species. Indications for use AUGMEKLAV can be used in children and adults for the treatment of the following infections: – acute bacterial sinusitis (certainly diagnosed); – acute otitis media; – exacerbation of chronic bronchitis (reliably diagnosed); – community-acquired pneumonia; – cystitis; – pyelonephritis; – infections of the skin and soft tissues, in particular infected inflammation of the skin and subcutaneous tissues, infected wounds from animal bites, severe periodontal abscess with spreading inflammation of adjacent tissues; – infections of bones and joints, in particular osteomyelitis. The drug AUGMEKLAV in the form of a suspension in dosages (400 mg + 57 mg) / 5 ml and (200 mg + 28.5 mg) / 5 ml is intended primarily for children weighing less than 40 kg. Consideration should be given to the information provided in official guidelines on the appropriate use of antibacterial medicines. Dosage and Administration Always use this medicine exactly as directed in this leaflet or as directed by your healthcare professional. If you have any questions or doubts, ask your doctor or pharmacist for advice. Method of application For oral administration. It is preferable to take AUGMEKLAV at the beginning of a meal in order to minimize the risk of developing or reduce the severity of developing adverse reactions from the gastrointestinal tract, as well as to optimize the absorption of amoxicillin and clavulanic acid. Treatment can be started with a combination of amoxicillin + clavulanic acid in the form for parenteral (intravenous) administration at the doses recommended for this route of administration and continued with the use of the drug AUGMECLAVE in the form of a suspension for internal use. Before use, the integrity of the ring of the first opening should be checked; if it is broken, this vial cannot be used – it must be returned to the pharmacy. The suspension must be prepared immediately before the first use. If there is an individual package for the syringe-dispenser kit and the liner for the syringe-dispenser, carefully open the individual packaging. The method of preparing the AUGMEKLAV suspension is shown in the figures below and differs for dosages (200 mg + 28.5 mg) / 5 ml and (400 mg + 57 mg) / 5 ml. A similar instruction for the preparation of the suspension is presented on the package. It is important to add exactly the indicated volume of water in order to obtain the concentration of active substances provided by the manufacturer. Adding less or more water will not allow you to accurately measure the necessary doses of the drug in the future and may affect the effectiveness and safety of the drug. For the convenience of controlling the correctness of adding the required volume of water for the preparation of the AUGMEKLAV suspension, a table for monitoring the preparation of the suspension is printed on the drug package (the amount of added water must be ticked). When diluting the drug AUGMEKLAV with a dosage of (200 mg + 28.5 mg) / 5 ml and (400 mg + 57 mg) / 5 ml according to the preparation method described above, 70 ml of an almost white suspension with a characteristic odor is formed with possible inclusions of white or almost white. Additional control of the volume of the prepared AUGMEKLAV suspension must be carried out according to the “70 ml” label applied to the vial: the volume of the prepared suspension should correspond (approximately) to the level of the “70 ml” label (may not completely match). It is not necessary to additionally bring the volume of the medicinal product to the “70 ml” mark indicated on the vial. After dilution, the suspension should be stored for no more than 7 days in a refrigerator at a temperature of 2-8 ° C. Before each subsequent use, the vial with the suspension must be shaken and wait for the foam to settle for 5 minutes. For accurate dosing of the drug AUGMEKLAV, you should use a dosing syringe and an insert for a dosing syringe, which are in the package with the drug. After the suspension is prepared, it is necessary to insert the insert under the dosing syringe into the neck of the vial. After inserting the syringe dispenser into the insert under the syringe dispenser and turning the bottle upside down and turning the bottle upside down, you must gently pull the piston of the syringe dispenser and dial the required volume of suspension. When taking an excess volume, the excess amount of the suspension should be released into the vial. When taking AUGMEKLAV suspension, you should take a vertical position of the body. Point the opening of the syringe towards the inner surface of the cheek and slowly press on the plunger of the syringe, gradually releasing the drug. Sharp pressure on the piston is not allowed. After use, close the vial with a cap, disassemble the dosing syringe, rinse it in clean drinking water, wait for the barrel and piston of the syringe to dry naturally or dry them with a clean cloth. The insert for the syringe dispenser should be left in the neck of the vial and not removed. Doses When choosing a dose of amoxicillin and clavulanic acid for the treatment of a particular infection, one should take into account: – the type of suspected pathogen and the characteristic profile of sensitivity / resistance to antibacterial agents for this pathogen (see section “Special instructions and precautions”); – severity and localization of infection; – age, body weight, kidney function status. The dose of the drug AUGMEKLAV is determined by the doctor and is calculated on the basis of amoxicillin and clavulanic acid, except in cases where a dose calculation is required for one of the components. It may be necessary to use other products that contain higher doses of amoxicillin and / or that contain amoxicillin and clavulanic acid in a different ratio. The decision to prescribe such funds is made by the doctor. The maximum daily dose of the drug AUGMEKLAV when used in children weighing less than 40 kg is 1000-2800 mg of amoxicillin + 143-400 mg of clavulanic acid, subject to the recommendations listed below. If a higher daily dose of amoxicillin is required, another drug should be selected to avoid the use of an unreasonably high daily dose of clavulanic acid. Children weighing less than 40 kg: – daily dose: from 25 mg of amoxicillin + 3.6 mg of clavulanic acid to 45 mg of amoxicillin + 6.4 mg of clavulanic acid per 1 kg of body weight; the daily dose should be divided into 2 doses; – in the case of certain infectious diseases (for example, otitis media, sinusitis, infections of the lower respiratory tract), the daily dose may be increased to 70 mg of amoxicillin + 10 mg of clavulanic acid per 1 kg of body weight; The daily dose should be divided into 2 doses. The combination of amoxicillin + clavulanic acid is available in various dosage forms (tablets, suspensions). If it is necessary to use the combination of amoxicillin + clavulanic acid in children aged 6 years and younger, it is preferable to use the drug AUGMECLAVE in the form of a suspension. The use of AUGMECLAVE suspension with a ratio of active ingredients 7:1 (doses (400 mg + 57 mg) / 5 ml and (200 mg + 28.5 mg) / 5 ml) cannot be recommended for children under 2 months of age, as there is no information available about the use in such patients and, as a result, it is not possible to make recommendations on the dosing regimen. The use of suspension AUGMEKLAV with a ratio of active ingredients 7:1 (doses (400 mg + 57 mg) / 5 ml and (200 mg + 28.5 mg) / 5 ml) in daily doses of more than 45 mg of amoxicillin + more than 6.4 mg of clavulanic acid per 1 kg of body weight cannot be recommended for children under 2 years of age, since there is no available information on the use of such doses in patients of this age group. Children weighing ≥40 kg and adults Dosage forms intended for adults should be used. Elderly patients Adult formulations should be used. Patients with impaired renal function In patients with a creatinine clearance of more than 30 ml / min, dose adjustment is not required. With a creatinine clearance of less than 30 ml / min, it is not recommended to use the AUGMECLAVE suspension in dosages (400 mg + 57 mg) / 5 ml and (200 mg + 28.5 mg) / 5 ml: in this drug, the ratio of active ingredients is 7: 1, and there is no available information on the correction of the dosing regimen in this group of patients with this ratio. Patients with impaired liver function In case of impaired liver function, the dose of the drug is selected with caution and regular liver function tests are required (see sections “Contraindications”, “Special Instructions and Precautions”). Duration of use When determining the duration of the course of treatment, the effectiveness and tolerability of the drug are taken into account on an individual basis. Some infections (such as osteomyelitis) require a long course of treatment. Therapy should not continue for more than 14 days without evaluating the result of using the drug (see section “Special instructions and precautions”). If you forget to take another dose of the medicine, it must be taken as soon as possible. The next usual dose should be taken at least 4 hours after the missed dose. Do not take a double dose to make up for a missed dose! If you have taken an overdose of the drug, seek advice from your doctor or a doctor at the nearest medical facility (for example, a polyclinic or a hospital emergency department); at the same time, if possible, take with you the package with the medicine and the leaflet for medical use. Symptoms that may develop after taking an overdose are listed in the “Overdose” section. You should not interrupt the course of treatment prescribed by your doctor, even if you feel better. If after completing the prescribed course of treatment, the state of health has not improved, you should consult your doctor again. Adverse reactions see See also section “Special instructions and precautions”. Like all medicines, AUGMECLAVE can cause side effects, although not everybody gets them. Conditions to watch out for (most serious adverse reactions) Immediate-type allergic reactions When using the drug, the possibility of developing immediate-type hypersensitivity reactions should be taken into account. These reactions occur suddenly, in the very near future (several seconds, minutes) after the use of the drug and can increase rapidly. May appear: – itchy red rash, accompanied by inflammation of the skin (urticaria); – other types of rash; – swelling of the larynx, glottis, face, lips, pharynx and / or tongue, which can lead to difficulty breathing due to impaired airway patency, difficulty swallowing or deterioration in the ability to speak (angioneurotic edema); – spasm of the bronchi, leading to difficulty breathing, a sharp decrease in blood pressure, a fast and weak pulse, abdominal pain, nausea, vomiting or diarrhea, dizziness, fainting or fainting, unexplained anxiety, fear of death (anaphylaxis). One symptom or several of these symptoms may develop at the same time. ➤ If you notice the development of these symptoms or other symptoms that, in your opinion, indicate the development of an allergic reaction of an immediate type, you must immediately stop using the drug and immediately consult a doctor, as such suddenly developing allergic reactions can be life threatening. Severe skin reactions These reactions may develop during use or after the end of the use of the drug: – Stevens-Johnson syndrome and toxic epidermal necrolysis (the latter is a more severe form in which extensive skin peeling occurs, covering up to 30 percent or more of the body surface) manifestations : widespread rash in the form of red spots, blisters, painful ulcers, accompanied by peeling and exfoliation of the skin and mucous membranes; the mucous membranes of the oral cavity, nose, eyes, genitals, any parts of the skin are affected; before the appearance of changes in the skin and mucous membranes, there may be an increase in body temperature, chills, sore throat, headache; – exanthematous pustulosis manifestations: widespread skin rash of red color with small vesicles containing pus; – bullous and exfoliative dermatitis manifestations: extensive inflammation and redness of the skin, accompanied by the formation of blisters or peeling of the skin; – drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) manifestations: flu-like symptoms with rash, fever, enlarged lymph nodes and changes in blood counts (including an increase in the number of eosinophils and liver enzymes); – erythema multiforme manifestation: skin rash, which is characterized by the appearance of spots in the form of small targets: the dark part in the center is surrounded by a paler zone, a dark ring forms along the contour of the pale zone; other types of spots, vesicles, and other skin changes may also form. ➤ If you notice the development of these symptoms or other symptoms that, in your opinion, indicate the development of a severe skin reaction, you must immediately stop using the drug and consult a doctor immediately, as some of the listed skin reactions can be life-threatening. Other allergic reactions Other allergic reactions that may develop during and after the end of the use of the drug: – skin rash; – inflammation of the blood vessels (vasculitis), which may appear as red or purple dots/spots raised above the surface of the skin; not only the skin, but also other areas of the body can be involved; – fever, joint pain, swollen lymph nodes in the neck, armpits or groin. ➤ Stop taking AUGMECLAVE suspension immediately and consult a doctor immediately! Inflammatory reaction in the colon (antibiotic-associated colitis, including pseudomembranous colitis and hemorrhagic colitis) This reaction may be accompanied by watery diarrhea (usually with blood and mucus), abdominal pain and/or fever. ➤ Seek medical advice immediately. Common side effects (may affect up to 1 in 10 people): – thrush or candidiasis (a yeast infection that can affect the skin or mucous membranes (eg, may affect areas such as the vagina, mouth) , skin folds) – Diarrhea – Nausea (especially when using high doses of the drug) – You can reduce the risk of developing or the severity of nausea by taking the drug before meals – Vomiting Uncommon adverse reactions (may occur in less than 1 person in 100 ): – dizziness, headache; – digestive disorders; – a moderate increase in the activity of liver enzymes (aspartate aminotransferase (ACT) and / or alanine aminotransferase (ALT)); the significance of this reaction is unknown; – skin rash, itching, urticaria (see above subsection about most serious adverse reactions) Rare adverse reactions (may affect up to 1 in 1,000 people): – reversible sleep decrease in the number of leukocytes in the blood (including a decrease in the number of neutrophils); – a decrease in the number of blood cells involved in blood clotting (platelets); – erythema multiforme (see above subsection “Severe skin reactions”). Frequency not known (the frequency of these reactions cannot be determined from the available data): – overgrowth of non-susceptible microorganisms; – reversible agranulocytosis (decrease in the level of leukocytes), hemolytic anemia (increased destruction of red blood cells), an increase in blood clotting time, an increase in prothrombin time; – angioedema, anaphylaxis (see the subsection “Immediate type allergic reactions” above); – a syndrome similar to serum sickness; – allergic vasculitis (see above subsection “Other allergic reactions”); – reversible excessive physical activity; – convulsions (may occur when using high doses of AUGMECLAVE suspension, in the presence of kidney disease or in the presence of factors predisposing to the development of convulsions); – aseptic meningitis (inflammation of the protective membrane of the brain) manifestations: stiff neck, headache, nausea, vomiting, fever and disorientation; – inflammatory reactions in the colon (see above subsection “Inflammatory reaction in the colon”); – black tongue that looks hairy; ➤ regular thorough oral hygiene helps prevent discoloration of the tongue; – discoloration of the teeth (very rarely reported in children); ➤ regular thorough oral hygiene helps prevent discoloration of the teeth; – inflammatory reactions in the liver (hepatitis); these reactions were observed during therapy with other penicillins and cephalosporins; – cholestatic jaundice; this reaction was noted during therapy with other penicillins and cephalosporins manifestations: yellowing of the skin and eyeballs, which is associated with an increase in the level of bilirubin (a substance produced in the liver) in the blood; – Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis, acute generalized exanthematous pustulosis (see subsection “Severe skin reactions” above); – inflammatory reactions in the kidneys (interstitial nephritis), the presence of crystals in the urine (crystalluria) (see section “Overdose”). Reporting adverse reactions It is important to report suspected adverse reactions after registration of a medicinal product in order to ensure continuous monitoring of the benefit/risk ratio of the medicinal product. In the event of adverse reactions listed in this package insert, as well as those not mentioned in it, or in case of ineffectiveness of the drug, it is necessary, first of all, to inform the attending physician immediately. You can also call the phone number of the drug manufacturer listed in the “Information about the manufacturer” section or report an adverse reaction / inefficiency to the Republican Unitary Enterprise “Center for Expertise and Testing in Healthcare” (https://www.rceth.by) . Contraindications – Hypersensitivity to any of the active ingredients or to any of the auxiliary components of the drug (see section “Composition”). – Hypersensitivity to any antibiotic from the penicillin series. – A history of severe allergic reactions of the immediate type (eg, anaphylactic shock) that developed in response to the use of any other of the beta-lactam antibiotics (eg, cephalosporins, carbapenems, or monobactams). – The presence of a history of jaundice or abnormal liver function that occurred during the use of a drug containing amoxicillin and clavulanic acid. If you know about the presence of contraindications or suspect them, be sure to provide this information to the doctor. Overdose If you use larger doses than you should, or accidental / intentional ingestion of the drug, you should consult a doctor as soon as possible. If possible, take the container of this medicine and/or this package leaflet with you. Symptoms In case of overdose, gastrointestinal disorders (nausea, vomiting, diarrhea), water and electrolyte balance disorders may occur. Urine crystals have been reported with amoxicillin, which in some cases has led to renal failure. Convulsions may occur in patients with impaired renal function or in those patients taking high doses of amoxicillin. There are reports of deposition of amoxicillin on the walls of urinary catheters, mainly after intravenous administration in large doses. Therefore, the patency of the catheter should be checked regularly. Treatment In violation of the function of the gastrointestinal tract, symptomatic treatment is indicated. Particular attention should be paid to the normalization of water and electrolyte balance. Amoxicillin and clavulanic acid can be removed from the vascular bed by hemodialysis. Interaction with other medicinal products and other types of interaction Tell your doctor or pharmacist about any medicines you are using, have recently taken or plan to use in the near future, including those that are available without a doctor’s prescription, before taking AUGMECLAVE will be assigned. Probenecid Concomitant use of probenecid is not recommended. Probenecid reduces tubular secretion of amoxicillin in the kidneys. Simultaneous administration of probenecid can lead to an increase in the concentration of amoxicillin in the blood plasma and a prolongation of its half-life from blood plasma, but at the same time does not have such an effect on similar parameters of clavulanic acid. Allopurinol The combined use of amoxicillin and allopurinol may increase the likelihood of allergic skin reactions. Tetracyclines Tetracyclines and other bacteriostatic. agents may interfere with the bactericidal effects of amoxicillin. Oral anticoagulants Oral anticoagulants and antibiotics from the penicillin group are widely used in clinical practice, with no evidence of interaction between drugs. However, the literature describes cases of an increase in the international normalized ratio (INR) in patients undergoing course treatment with amoxicillin while taking acenocoumarol or warfarin. If the combined use of oral anticoagulants and AUGMEKLAV suspension is considered necessary, careful monitoring of the value of prothrombin time or INR should be carried out at the beginning of drug therapy, when changing its dose and after stopping therapy. Dose adjustment of oral anticoagulants may be required (see sections “Special instructions and precautions” and “Adverse reactions”). Methotrexate Penicillins can reduce the excretion of methotrexate, which will increase the likelihood of manifestation of the toxic properties of the latter. Mycophenolate mofetil In patients treated with mycophenolate mofetil, there was a decrease in the pre-dose (observed before the next dose) concentration of the active metabolite (mycophenolic acid) by approximately 50% after the start of the combination of amoxicillin + clavulanic acid in oral forms. The change in pre-dose concentration probably does not accurately reflect overall changes in mycophenolic acid exposure. Therefore, in the absence of clinical signs of graft dysfunction, dose adjustment of mycophenolate mofetil is usually not required. However, in the process of joint use and in the immediate period after the completion of the use of the combination of amoxicillin + clavulanic acid, careful clinical monitoring is necessary. Special instructions and precautions Hypersensitivity reactions Before starting the use of a combination of amoxicillin + clavulanic acid, it is imperative to provide the doctor with detailed information about allergic reactions (if any) that have ever been observed in response to the use of an antibiotic from the group of penicillins, cephalosporins or other beta- lactam (see section “Contraindications”), as well as any other allergic reactions. There are reports of the development of serious hypersensitivity reactions, sometimes fatal (including anaphylactoid reactions and severe skin reactions), in patients treated with penicillins. These reactions are more likely in people with a history of hypersensitivity to penicillins or a tendency to develop allergic reactions. If an allergic reaction develops, the amoxicillin/clavulanic acid combination should be discontinued immediately and appropriate alternative treatment initiated. Skin reactions There may be multiple pustules on reddened skin with a simultaneous increase in body temperature, which may be symptoms of acute generalized exanthematous pustulosis. If such a reaction occurs, you should immediately stop taking the drug; in the future, the use of drugs containing amoxicillin is contraindicated in any case. The combination of amoxicillin + clavulanic acid should be avoided if infectious mononucleosis is suspected. Taking amoxicillin with infectious mononucleosis can lead to a measles-like rash. There are reports of the development of serious hypersensitivity reactions, sometimes fatal (including severe skin adverse reactions), in patients treated with penicillins. If an allergic reaction develops on the part of the skin and subcutaneous tissues, the use of the amoxicillin + clavulanic acid combination should be immediately discontinued and an appropriate alternative treatment should be initiated. Convulsions Convulsions may occur in patients: – with impaired renal function; – taking amoxicillin in high doses; – with the presence of predisposing factors (for example, a history of seizures, treated epilepsy or meningeal disorders). Susceptibility of microorganisms to amoxicillin If it is proved that the infection is caused by a microorganism susceptible to amoxicillin, consideration should be given to the advisability of using amoxicillin instead of the combination of amoxicillin + clavulanic acid, taking into account the recommendations of the official guidelines. AUGMECLAVE should not be used if there is a high risk that the suspected microorganism is resistant to beta-lactams and this resistance is not mediated by clavulanic acid-inhibited beta-lactamases, but by other mechanisms. This medicinal product should not be used to treat infections caused by penicillin-resistant strains of S. pneumoniae. Overgrowth of non-susceptible organisms Long-term use of amoxicillin can sometimes lead to overgrowth of non-susceptible organisms. Antibiotic-associated colitis Antibiotic-associated colitis has been reported with almost all antibacterial drugs. Its severity can vary from mild to life-threatening (see section “Adverse reactions”). If a patient develops diarrhea during or after treatment with any antibiotic, this diagnosis should always be assumed. If antibiotic-associated colitis is suspected or confirmed, the amoxicillin/clavulanic acid combination should be discontinued immediately and appropriate treatment instituted. In this situation, antiperistaltic drugs are contraindicated. Impaired liver function The combination of amoxicillin + clavulanic acid should be used with caution in patients with signs of impaired liver function (see sections “Dosage and Administration”, “Contraindications”, “Adverse reactions”). Adverse reactions from the liver were noted mainly in men and elderly patients. The risk of developing such reactions is probably higher with prolonged use of the drug. These reactions are very rare in children. In all categories of patients, signs and symptoms of liver dysfunction usually develop during or shortly after completion of treatment, however, in some cases, they become apparent only a few weeks after completion of treatment. These reactions are usually reversible. Adverse reactions from the liver can be severe, very rarely, with the development of such reactions, deaths were noted. In most cases, severe reactions developed in patients who had a severe concomitant disease or who were taking drugs at the same time that can have an undesirable effect on liver function. Impaired renal function See the section “Method of application and dosage”. Crystalluria In patients with reduced urine output, crystalluria (crystals in the urine) has been observed in very rare cases, mainly with the introduction of an antibiotic parenterally. When using amoxicillin in high doses, it is recommended to ensure the introduction of an adequate amount of fluid and maintain a sufficient level of urine output in order to reduce the likelihood of crystalluria associated with taking amoxicillin. In patients with urinary catheters, it is necessary to regularly check the patency of the urinary tract (see sections “Adverse reactions” and “Overdose”). Long-term treatment With long-term use of the combination of amoxicillin + clavulanic acid, it is recommended to regularly monitor the functions of various organs, including the functions of the kidneys, liver, hematopoiesis. When taking amoxicillin, there have been cases of increased activity of liver enzymes and changes in the cellular composition of the blood (see section “Adverse reactions”). Anticoagulants In rare cases, prolongation of prothrombin time has been reported in patients taking the combination of amoxicillin + clavulanic acid. Appropriate monitoring should be carried out if the patient is taking AUGMECLAVE with anticoagulants. It may be necessary to adjust the dose of oral anticoagulant in order to maintain the level of anticoagulation at the desired level (see sections “Interaction with other medicinal products and other forms of interaction” and “Adverse reactions”). Interference with laboratory tests Elevated serum and urinary concentrations of amoxicillin may interfere with the results of certain laboratory tests. During treatment with AUGMEKLAV suspension, if it is necessary to determine the level of glucose in the urine, it is recommended to use enzymatic glucose oxidase methods, since when using non-enzymatic methods, false positive results may be noted due to high concentrations of amoxicillin in the urine. In the presence of amoxicillin, the results of determining the concentration of estriol in pregnant women may be distorted. The presence of clavulanic acid in the medicinal product may cause non-specific binding of IgG and albumin to erythrocyte membranes, which may lead to a false positive Coombs test result. There are reports of positive results when conducting an enzyme-linked immunosorbent assay (ELISA) aimed at detecting Aspergillus antigen in patients treated with the combination of amoxicillin + clavulanic acid, who subsequently did not develop aspergillosis. Cross-reactions between non-Aspergillus polysaccharides and polyfuranoses have also been reported using ELISA assays developed for the diagnosis of aspergillosis. Thus, positive test results in patients receiving the combination amoxicillin + clavulanic acid should be interpreted with caution and confirmed by other diagnostic methods. Auxiliary components AUGMEKLAV contains aspartame, which is a source of phenylalanine. This component may have a negative effect if you are diagnosed with phenylketonuria (a rare disease associated with a genetic disorder in which phenylalanine accumulates in the body because phenylalanine is not excreted from the body properly). Patients with phenylketonuria should use this drug with caution. – Dosage (200 mg + 28.5 mg) / 5 ml: 1 ml of suspension contains 1.25 mg of aspartame. – Dosage (400 mg + 57 mg) / 5 ml: 1 ml of suspension contains 2.5 mg of aspartame. There are no