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Megasef tablets p/o 500 mg packaging No. 10

Megasef 500

International nonproprietary name Cefuroxime

Dosage form Film-coated tablets 250 mg or 500 mg

Composition One tablet contains the active substances: cefuroxime axetil 300.72 (equivalent to cefuroxime 250.0) and 601.44 (equivalent to cefuroxime 500.0), excipients: pregelatinized starch, crospovidone (Kollidon Cl), croscarmellose sodium, sodium lauryl sulfate, magnesium stearate, silicon dioxide coll oid anhydrous ( Aerosil 200), film shell: material for shell No. 1 Sepifilm LP 770, purified water, film shell composition: hypromellose (methylhydroxypropylcellulose) (E464), microcrystalline cellulose (E460), stearic acid (E570), titanium dioxide (E171)

Description White film-coated tablets, oblong in shape, marked NOBEL on one side and scored on the other.

Pharmacotherapeutic group Antimicrobial drugs for systemic use. Antibacterial drugs for systemic use. Second generation cephalosporins ATC code J01DC02

Pharmacological properties Pharmacokinetics Cefuroxime axetil is rapidly absorbed from the gastrointestinal tract and hydrolyzed by nonspecific esterases of the intestinal mucosa and blood to cefuroxime. Plasma protein binding is 50%. Cefuroxime is distributed in tissues and body fluids. When taking the drug after meals, the maximum plasma concentration for dosages of 125 mg, 250 mg and 500 mg is 2.1 mcg/ml, 4.1 mcg/ml, 7 mcg/ml, respectively. The maximum concentration is reached 3 hours after taking the drug. Therapeutic concentrations in the cerebrospinal fluid are achieved only with meningitis. Penetrates through the placenta and is excreted in breast milk. It is excreted unchanged in the urine. The half-life is approximately 1.2 hours. Pharmacodynamics Cefuroxime is a second-generation, broad-spectrum cephalosporin antibiotic. It has a bactericidal effect by inhibiting the synthesis of bacterial cell walls. Cefuroxime acetylates membrane-bound transpeptidases, thereby disrupting the peptido-glycan cross-linking necessary to ensure cell wall strength and rigidity. Cefuroxime is resistant to the action of many bacterial beta-lactamases, as a result of which it is active against most types of microorganisms resistant to penicillin and amoxicillin. Cefuroxime is active against the following microorganisms: Gram-negative bacteria: Escherichia coli, Haemophilus influenzae (including species that produce beta-lactamases), Haemophilus parainfluenzae, Klebsiellapneumoniae, Moraxella catarrhalis (including species that produce beta-lactamases), Neisseria gonorrhoeae (including species that produce beta -lactamases), Salmonella spp., Shigella spp., Proteus mirabilis, Enterobacter spp. Gram-positive bacteria: Staphylococcus aureus (including beta-lactamase producing species), Streptococcus pneumoniae, Streptococcus pyogenes. Certain species of enterococci, such as Enterococcus faecalis, are resistant to cefuroxime. Anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Fusobacterium spp.

Indications for use - acute bronchitis, exacerbation of chronic bronchitis, pneumonia - otitis, sinusitis, tonsillitis, pharyngitis - pyelonephritis, cystitis, urethritis - abdominal infections - gynecological infections - infections of bones and joints - infections of the skin and soft tissues.

Method of administration and dosage The recommended dose for adults and children over 12 years of age is 250 mg 2 times a day. For more severe infections or infections caused by less sensitive microorganisms, 500 mg 2 times a day is recommended. For uncomplicated urinary tract infections, the recommended dose is 250 mg once a day. If necessary, in some patients with urinary tract infections, the dosage can be increased to 250 mg 2 times a day. The maximum daily dose for adults is 6 g. Typically, the duration of treatment is 7 days (from 5 to 10 days). The course of treatment should be extended to 10 days in patients with infections caused by beta-hemolytic streptococcus to avoid the occurrence of acute rheumatic fever or acute glomerulonephritis. For patients with impaired renal function, the dosage regimen is set taking into account creatinine clearance values. For better absorption, the drug should be taken after meals. The tablets should be swallowed whole without chewing, so children under 12 years of age can use the drug in injection form.

Side effects Common (?1/100, <1/10) eosinophilia headache nausea, diarrhea short-term increase in the level of liver enzymes (ALT, AST, LDH) Uncommon (?1/1000, <1/100) vomiting eczema positive Coombs test result , thrombocytopenia, leukopenia (sometimes severe) Rarely (?1/10000, <1/1000) pseudomembranous colitis urticaria, itching Very rarely (<1/10000) hemolytic anemia drug fever, serum sickness, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis jaundice (mainly cholestatic), hepatitis

Contraindications - hypersensitivity to cephalosporin antibiotics, penicillins, carbapinems - children under 12 years of age - first trimester of pregnancy

Drug interactions Megasef is not active in the gastrointestinal tract, has minimal impact on intestinal flora and vitamin K synthesis. When taken simultaneously, it enhances the anticoagulant effect of warfarin. When used simultaneously with loop diuretics, the risk of nephrotoxicity increases. Probenecid competes with Megasef for renal tubular secretion, which leads to increased plasma concentrations of cefuroxime. To determine plasma glucose levels in patients taking Megasef, it is recommended to use glucose oxidase or hexokinase methods. Megasef does not affect serum and urine creatinine levels.

Special instructions: Use with caution in case of severe renal dysfunction, or if there is a history of colitis. In patients with hypersensitivity to penicillins, allergic reactions to cephalosporin antibiotics are possible. If a severe allergic reaction to Megasef occurs, it is necessary to discontinue the drug and prescribe appropriate treatment; in especially severe cases, there may be a need for resuscitation measures. Long-term use of the drug, like other broad-spectrum antibiotics, can lead to increased proliferation of microorganisms insensitive to the drug (for example, Candida, Enterococci, Clostridium difficile), and therefore it may be necessary to discontinue the drug. When using broad-spectrum antibiotics, the development of pseudomembranous colitis is possible; this must be kept in mind when patients experience diarrhea during or after antibacterial therapy. During treatment, a positive direct Coombs reaction and a false positive urine reaction to glucose are possible.

Pregnancy and lactation period Use in the second and third trimesters of pregnancy, as well as during lactation, is possible in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms. Not installed.

Overdose Symptoms: central nervous system stimulation, convulsions. Treatment: symptomatic treatment, peritoneal and hemodialysis. Release form and packaging 10 tablets are placed in a blister pack made of polyvinyl chloride film and printed aluminum foil. 1 contour package, together with instructions for medical use in the state and Russian languages, is placed in a cardboard pack with a hologram of the manufacturer.

Storage conditions Store at a temperature not exceeding 25C in a dry, dark place. Keep out of the reach of children!

Shelf life: 3 years Do not use after expiration date.

Conditions for dispensing from pharmacies By prescription

Megasef 750mg 6ml Powder For Injection

Trade name: MEGASEF® 750 International nonproprietary name: Cefuroxime Dosage form : Powder for the preparation of solution for injection complete with solvent (6 ml in ampoule) Composition: active substance - sterile cefuroxime sodium salt 750 mg equivalent to anhydrous cefuroxime, solvent - water for injection : 6 ml in an ampoule - for a dosage of 750 mg Description: White or whitish, slightly hygroscopic powder Pharmacotherapeutic group: Antimicrobial drugs for systemic use. Other beta-lactam antibacterial drugs. Second generation cephalosporins.

Pharmacological properties:

Pharmacokinetics After intramuscular injection of 750 mg of cefuroxime, the average peak serum concentration (Cmax) is 27 mcg/ml. It reaches plasma concentration (tmax) after approximately 45 minutes. The half-life (t1/2) after intramuscular or intravenous injection is approximately 80 minutes. Approximately 50% of cefuroxime is bound to serum protein. Cefuroxime is found in volumes exceeding the maximum effective concentration in pleural fluid, intra-articular fluid, bile, saliva, bones and in the fluid of the chambers of the eye. Approximately 89% of the dose of cefuroxime is excreted unchanged by the kidneys within 8 hours, resulting in high concentrations in urine. Cefuroxime crosses the blood-brain barrier in the case of meningitis.

Pharmacodynamics MEGACEF® is a second-generation cephalosporin antibiotic with a broad spectrum of action. It has a bactericidal effect by inhibiting the synthesis of bacterial cell walls. MEGASEF® acetylates membrane-bound transpeptidases, thereby disrupting the peptido-glycan cross-linking necessary to ensure cell wall strength and rigidity. MEGACEF® is resistant to many bacterial beta-lactamases, making it active against most species resistant to penicillin and amoxicillin. MEGASEF® is active against the following microorganisms: Gram-negative bacteria: Escherichia coli, Haemophilus influenzae (including species producing beta-lactamases), Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis (including species producing beta-lactamases), Neisseria gonorrhoeae (including species producing beta-lactamases), Salmonella spp., Shigella spp., Proteus mirabilis, Enterobacter spp. Gram-positive bacteria: Staphylococcus aureus (including beta-lactamase producing species), Streptococcus pneumoniae, Streptococcus pyogenes. Certain species of enterococci, such as Enterococcus faecalis, are resistant to cefuroxime. Anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Fusobacterium spp. Indications for use: - acute bronchitis, exacerbation of chronic bronchitis, bacterial pneumonia, lung abscess - otitis media, sinusitis, tonsillitis, pharyngitis - acute and chronic pyelonephritis, cystitis, urethritis, asymptomatic bacteriuria - skin and soft tissue infections, incl. erysipelas, wound infections - osteomyelitis, septic arthritis - pelvic inflammatory diseases - gonorrhea - peritonitis - septicemia - meningitis - endocarditis - prevention of infectious complications during operations on the abdominal organs, pelvis, heart, lungs, esophagus and blood vessels, during orthopedic operations Directions for use and dosage: Adults. For moderate infections, recommends 750 mg intramuscularly or intravenously 3 times a day. For severe infections - 1.5 g intravenously 3 times a day. If necessary, the interval between injections can be reduced to 6 hours; The daily dose of the drug is 3 - 6g. The course of treatment is 5–10 days. For some infections, the use of the drug 0.75-1 g 2 times a day is more effective. The course of treatment is 5–10 days. In the future, it is possible to use the tablet form of MEGASEF®. Children over 3 months. The recommended dose of the drug is 30-100 mg/kg per day in 3-4 administrations. For most infections, the optimal daily dose is 60 mg/kg. Newborns are prescribed 30-100 mg/kg per day in 2-3 administrations. Pneumonia . For pneumonia, it is recommended to administer the drug 1.5 g or 2 times a day (intramuscularly or intravenously) for 48-72 hours. In the future, it is possible to use the tablet form of MEGASEF® Gonorrhea. For gonorrhea, the drug is prescribed in a dose of 1.5 g once in the form of 1 injection or in the form of 2 injections of 750 mg. Meningitis. For meningitis, adults are prescribed 3 g intravenously 3 times a day. Children over 3 months are prescribed intravenously 150-250 mg/kg per day in 3-4 injections. Newborns are prescribed the drug intravenously at a dose of 100 mg/kg per day. To prevent infectious complications during abdominal, pelvic and orthopedic operations, the drug is administered intravenously in a dose of 1.5 g simultaneously with induction of anesthesia. If necessary, additional injections of the drug intramuscularly at a dose of 750 mg are possible after 8 and 16 hours. For operations on the heart, lungs, esophagus and blood vessels, 1.5 g of the drug is administered intravenously with induction of anesthesia, then 750 mg is administered 3 times a day over the next 24 -48 hours. Renal failure. If renal function is impaired, a reduced dose should be used. The dosage should be determined by the degree of renal impairment and the sensitivity of the microorganism. Dosage of MEGACEF® for injection in adults with impaired renal function: Creatinine clearance (ml/min) Dose (mg) Frequency > 20,750 – 1500 Every 8 hours 10 – 20,750 Every 12 hours Patients with renal failure on continuous hemodialysis using arterial -venous shunt or high-flow hemofiltration in intensive care units, MEGASEF®. prescribed in a dose of 750 g 2 times a day. For patients undergoing low-rate hemofiltration, doses recommended for renal impairment are prescribed. Rules for preparing solutions for parenteral administration For intramuscular or intravenous injections, add water for injection (according to the table), shake gently until a suspension is formed. For IM administration: Dose Amount of water for injection 750 mg 3 ml For IV administration: Dose Amount of water for injection 750 mg 6 ml Jet IV administration - slowly over 3-5 minutes. For continuous intravenous infusion, MEGASEF® solution can be added to the following infusion solutions: sodium chloride solution 0.9%, dextrose solution 5% and 10%.

Side effects: - thrombophlebitis (with intravenous administration), pain at the injection site (with intramuscular administration) - nausea, vomiting, diarrhea - transient increase in the activity of liver transaminases, cholestatic jaundice, hepatitis, pseudomembranous colitis - skin rash, itching, eosinophilia, Quincke's edema , erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, fever, anaphylaxis - leukopenia, neutropenia, thrombocytopenia, hemolytic anemia, hypoprothrombinemia (with long-term use in high doses) - interstitial nephritis, candidiasis - hearing impairment Contraindications: - hypersensitivity to cefuroxime and other cephalosporins - pregnancy and lactation - bleeding and diseases of the gastrointestinal tract Drug interactions: It is recommended to use the glucose oxidase or hexokinase method when determining plasma glucose levels in patients receiving cefuroxime. False-positive reactions for the presence of glucose in urine may occur in tests with copper reduction (Benedict, Fehling, Clinitest). Enzyme tests should be used to determine glycosuria. However, it does not cause false-positive results like some other cephalosporins. A positive direct Coombs reaction is also possible. Cefuroxime, by suppressing the intestinal flora, prevents the synthesis of vitamin K. Therefore, when used simultaneously with drugs that reduce platelet aggregation (non-steroidal anti-inflammatory drugs, salicylates, sulfinpyrazone), the risk of bleeding increases. For the same reason, when used simultaneously with anticoagulants, an increase in the anticoagulant effect is observed. When used simultaneously with loop diuretics, the risk of nephrotoxicity increases. Coadministration of probenecid with cefuroxime slows tubular secretion, increases peak serum concentrations by approximately 40%, and increases the half-life by approximately 30%. Special instructions: In patients with hypersensitivity to penicillins, allergic reactions to cephalosporin antibiotics are possible; In such patients, cephalosporins should be prescribed with caution. Large doses of cephalosporins should be prescribed with caution in cases of severe renal impairment, as well as in patients receiving concomitant treatment with strong diuretics such as furosemide and aminoglycosides. Patients with diseases of the gastrointestinal tract (especially colitis) should use with caution. If an allergic reaction occurs, you must stop taking the drug. Peculiarities of the drug's influence on the ability to drive a vehicle or operate potentially dangerous machinery. The drug does not affect the ability to drive a vehicle or operate potentially dangerous machinery. Overdose: Symptoms: convulsions. Treatment: hemodialysis and peritoneal dialysis. Release form and packaging: 750 mg of the drug is placed in colorless glass bottles, closed with rubber stoppers with aluminum caps. Self-adhesive labels are glued to the bottles. 6 ml of solvent are placed in colorless glass ampoules and a label is attached. 1 bottle of the drug and 1 ampoule of solvent, along with instructions for medical use in the state and Russian languages, are placed in a cardboard box. Storage conditions: Store in a dry place, protected from light, at a temperature not exceeding 25°C. Keep out of the reach of children! Shelf life: 3 years. Do not use after the expiration date. Conditions for dispensing from pharmacies: By prescription

Megasef 500 mg No. 10 tablet.

Instructions for medical use of the drug Megasef® 250 Megasef® 500 Trade name Megasef® 250 Megasef® 500 International nonproprietary name Cefuroxime Dosage form Film-coated tablets 250 mg or 500 mg Composition One tablet contains the active substance: cefuroxime axetil 300.72 (equivalent cefuroxime 250.0) and 601.44 (equivalent to cefuroxime 500.0), excipients: pregelatinized starch, crospovidone (Kollidon Cl), croscarmellose sodium, sodium lauryl sulfate, magnesium stearate, colloidal anhydrous silicon dioxide (Aerosil 200), film shell: shell material No. 1 Sepifilm LP 770, purified water, film-coated composition: hypromellose (methylhydroxypropylcellulose) (E464), microcrystalline cellulose (E460), stearic acid (E570), titanium dioxide (E171) Description Film-coated tablets, white, oblong, labeled “NOBEL” on one side and a mark on the other. Pharmacotherapeutic group Antimicrobial drugs for systemic use. Antibacterial drugs for systemic use. Second generation cephalosporins ATC code J01DC02 Pharmacological properties Pharmacokinetics Cefuroxime axetil is rapidly absorbed from the gastrointestinal tract and hydrolyzed by nonspecific esterases of the intestinal mucosa and blood to cefuroxime. Plasma protein binding is 50%. Cefuroxime is distributed in tissues and body fluids. When taking the drug after meals, the maximum plasma concentration for dosages of 125 mg, 250 mg and 500 mg is 2.1 mcg/ml, 4.1 mcg/ml, 7 mcg/ml, respectively. The maximum concentration is reached 3 hours after taking the drug. Therapeutic concentrations in the cerebrospinal fluid are achieved only with meningitis. Penetrates the placenta and is excreted in breast milk. It is excreted unchanged in the urine. The half-life is approximately 1.2 hours. Pharmacodynamics Cefuroxime is a second-generation cephalosporin antibiotic with a broad spectrum of action. It has a bactericidal effect by inhibiting the synthesis of bacterial cell walls. Cefuroxime acetylates membrane-bound transpeptidases, thereby disrupting the peptidoglycan cross-linking necessary to ensure cell wall strength and rigidity. Cefuroxime is resistant to the action of many bacterial beta-lactamases, as a result of which it is active against most types of microorganisms resistant to penicillin and amoxicillin. Cefuroxime is active against the following microorganisms: Gram-negative bacteria: Escherichia coli, Haemophilus influenzae (including species that produce beta-lactamases), Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis (including species that produce beta-lactamases), Neisseria gonorrhoeae (including species that produce beta-lactamases), Salmonella spp., Shigella spp., Proteus mirabilis, Enterobacter spp. Gram-positive bacteria: Staphylococcus aureus (including beta-lactamase producing species), Streptococcus pneumoniae, Streptococcus pyogenes. Certain species of enterococci, such as Enterococcus faecalis, are resistant to cefuroxime. Anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Fusobacterium spp. Indications for use - acute bronchitis, exacerbation of chronic bronchitis, pneumonia - otitis, sinusitis, tonsillitis, pharyngitis - pyelonephritis, cystitis, urethritis - abdominal infections - gynecological infections - infections of bones and joints - infections of the skin and soft tissues. Method of administration and dosage The recommended dose for adults and children over 12 years of age is 250 mg 2 times a day. For more severe infections or infections caused by less sensitive microorganisms, 500 mg twice daily is recommended. For uncomplicated urinary tract infections, the recommended dose is 250 mg once a day. If necessary, in some patients with urinary tract infections, the dosage may be increased to 250 mg 2 times a day. The maximum daily dose for adults is 6 g. Typically, the duration of treatment is 7 days (from 5 to 10 days). The course of treatment should be extended to 10 days in patients with infections caused by beta-hemolytic streptococcus to avoid the occurrence of acute rheumatic fever or acute glomerulonephritis. For patients with impaired renal function, the dosage regimen is set taking into account creatinine clearance values. For better absorption, the drug should be taken after meals. The tablets should be swallowed whole without chewing, so children under 12 years of age can use the drug in injection form. Side effects Often (≥1/100, <1/10) - eosinophilia - headache - nausea, diarrhea - short-term increase in the level of liver enzymes (ALT, AST, LDH) Uncommon (≥1/1000, <1/100) - vomiting - eczema - positive Coombs test, thrombocytopenia, leukopenia (sometimes severe) Rare (≥1/10000, <1/1000) - pseudomembranous colitis - urticaria, itching Very rare (<1/10000) - hemolytic anemia - drug fever, serum fever disease, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis - jaundice (mainly cholestatic), hepatitis Contraindications - hypersensitivity to cephalosporin antibiotics, penicillins, carbapinems - children under 12 years of age - first trimester of pregnancy Drug interactions Megasef ® is not active in the gastrointestinal tract, has minimal effects on intestinal flora and the synthesis of vitamin K. When taken simultaneously, it enhances the anticoagulant effect of warfarin. When used simultaneously with loop diuretics, the risk of nephrotoxicity increases. Probenecid competes with Megasef® for renal tubular secretion, which leads to increased plasma concentrations of cefuroxime. To determine plasma glucose levels in patients taking Megasef®, it is recommended to use glucose oxidase or hexokinase methods. Megasef® does not affect creatinine levels in serum or urine. Special instructions: Use with caution in case of severe renal dysfunction, or if there is a history of colitis. In patients with hypersensitivity to penicillins, allergic reactions to cephalosporin antibiotics are possible. If a severe allergic reaction to Megasef® occurs, it is necessary to discontinue the drug and prescribe appropriate treatment; in especially severe cases, resuscitation measures may be necessary. Long-term use of the drug, like other broad-spectrum antibiotics, can lead to increased proliferation of microorganisms insensitive to the drug (for example, Candida, Enterococci, Clostridium difficile), and therefore it may be necessary to discontinue the drug. When using broad-spectrum antibiotics, the development of pseudomembranous colitis is possible; this must be kept in mind if patients experience diarrhea during or after antibacterial therapy. During treatment, a positive direct Coombs test and a false positive urine test for glucose are possible. Pregnancy and lactation period Use in the second and third trimesters of pregnancy, as well as during lactation, is possible in cases where the expected benefit of therapy for the mother outweighs the potential risk for the fetus. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms. Not installed. Overdose Symptoms: central nervous system stimulation, convulsions. Treatment: symptomatic treatment, peritoneal and hemodialysis. Release form and packaging 10 tablets are placed in a blister pack made of polyvinyl chloride film and printed aluminum foil. 1 contour package, together with instructions for medical use in the state and Russian languages, is placed in a cardboard pack with a hologram of the manufacturer. Storage conditions Store at a temperature not exceeding 25°C in a dry place, protected from light. Keep out of the reach of children! Shelf life: 3 years Do not use after expiration date. Conditions for dispensing from pharmacies By prescription Republic of Kazakhstan Almaty, st. Shevchenko 162 E. Owner of the registration certificate of Nobel Almaty Pharmaceutical Factory JSC, Republic of Kazakhstan Address of the organization that accepts claims from consumers regarding the quality of products (products) on the territory of the Republic of Kazakhstan: Nobel Almaty Pharmaceutical Factory JSC, Republic of Kazakhstan, Almaty, st. Shevchenko 162 E. Phone number: (+7 Fax number: (+7 Email address