Bactoclav - instructions for use, dose, side effects, contraindications

active ingredients: amoxicillin trihydrate - 150,680 mg in terms of amoxicillin - 131,250 mg *; potassium clavulanate + silicon dioxide (1: 1 mixture) - 81.880 mg, in terms of potassium clavulanate - 40.940 mg, calculated as clavulanic acid - 34.375 mg *;

Excipients: silicon dioxide - 83,900 mg, silicon dioxide colloid - 25,000 mg, hypromellose - 135 mg, aspartame - 12,500 mg, succinic acid - 0,850 mg, xanthan gum - 12,500 mg, raspberry aroma - 22,500 mg, flavoring orange - 26,500 mg, caramel flavoring - 23.750 mg.

5 ml of the finished suspension of 250 mg + 62.5 mg / 5 ml contain:

active ingredients: amoxicillin trihydrate - 301,350 mg in terms of amoxicillin - 262,500 mg *; potassium clavulanate + silicon dioxide (1: 1 mixture) - 163.760 mg, in terms of potassium clavulanate - 81.880 mg, calculated as clavulanic acid - 68.750 mg *;

Excipients: silicon dioxide - 66,135 mg, silicon dioxide colloid - 25,000 mg, hypromellose - 135 mg, aspartame - 12,500 mg, succinic acid - 0.930 mg,gum xanthan - 12,500 mg, raspberry flavor - 22,500 mg, flavoring orange - 26,500 mg, caramel flavoring - 23,790 mg.

5 ml of the finished suspension of 400 mg + 57 mg / 5 ml contains:

active ingredients: amoxicillin trihydrate - 482,160 mg in terms of amoxicillin - 420,000 mg *; potassium clavulanate + silicon dioxide (1: 1 mixture) - 149.360 mg, in terms of potassium clavulanate - 74.680 mg, calculated on clavulanic acid - 62,700 mg *;

Excipients: silicon dioxide - 175,857 mg, silicon dioxide colloid - 59,750 mg, hypromellose - 33,285 mg, aspartame - 23,714 mg, succinic acid - 1,714 mg, xanthan gum - 9.571 mg, raspberry aroma - 45.285 mg, flavoring orange - 52.429 mg, caramel flavoring - 47.714 mg.

* - Provision is made for the excess of amoxicillin in 5% and clavulanic acid in 10% to ensure the claimed dosage when extracting the suspension from the bottle and compensating for possible production losses.

Description:

Almost white, free-flowing powder.

Almost white suspension with a characteristic caramel-fruit smell.

Pharmacotherapeutic group:Antibiotic-penicillin semisynthetic + beta-lactamase inhibitor

ATX: & nbsp

J.01.C.R.02 Amoxicillin in combination with enzyme inhibitors

Pharmacodynamics:

Amoxicillin is a semisynthetic broad-spectrum antibiotic that is active against many Gram-positive and Gram-negative microorganisms. Amoxicillin is destroyed by microbial enzymes - beta-lactamases, and therefore does not affect the microorganisms that produce these enzymes.

Clavulanic acid is a beta-lactamase inhibitor structurally related to penicillins, which has the ability to inactivate a wide range of beta-lactamases found in microorganisms resistant to penicillins and cephalosporins. Clavulanic acid has sufficient efficacy against plasmid beta-lactamases, which most often determine the resistance of bacteria, and is not effective against type 1 chromosomal beta lactamases that are not inhibited by clavulanic acid.

The presence of clavulanic acid in the preparation protects amoxicillin from destruction by enzymes - beta-lactamases, which allows to expand the antibacterial spectrum of amoxicillin.

Below is the sensitivity to a combination of amoxicillin with clavulanic acid in vitro.

Bacteria, usually sensitive to a combination of amoxicillin and clavulanic acid

Gram-positive aerobes:

Bacillus anthracis, Enterococcus faecalis, Listeria monocytogenes, Nocardia asteroids, Streptococcus pyogenes^1,2, Streptococcus agalactiae^1,2, Streptococcus spp. (other beta-hemolytic streptococci)^1,2, Staphylococcus aureus (sensitive to methicillin)^1,2, Staphylococcus saprophyticus (sensitive to methicillin), coagulase-negative Staphylococcus spp. (sensitive to methicillin).

Gram-negative aerobes:

Bordetella pertussis, Haemophilus influenzae¹, Helicobacter pylori, Moraxella catarrhalis¹(Branhamella catarrhalis), Neisseria gonorrhoeae, Pasteurella multocida, Vibrio cholerae.

Gram-positive anaerobes:

Clostridium spp., Peptococcus niger, Peptostreptococcus magnus, Peptostreptococcus micros, Peptostreptococcus spp.

Gram-negative anaerobes:

Bacteroides spp. (including Bacteroides fragilis), Capnocytophaga spp., Eikenella corrodens, Fusobacterium nucleatum, Fusobacterium spp., Porphyromonas spp., Prevotella spp.

Other:

Borrelia burgdorferi, Leptospira icterohaemorrhagiae, Treponema pallidum.

Microorganisms for which the acquired resistance to a combination of amoxicillin with clavulanic acid

Gram-negative aerobes:

Escherichia coli¹, Klebsiella spp. (including Klebsiella oxytoca, Klebsiella pneumoniae¹), Proteus spp. (at Tom number of Proteus mirabilis, Proteus vulgaris), Salmonella spp., Shigella spp.

Gram-positive aerobes:

Corynebacterium spp., Enterococcus faecium, Streptococcus pneumoniae^1,2, Streptococcus spp. groups viridans.

Microorganisms possessing natural resistance to a combination of amoxicillin and clavulanic acid

Gram-negative aerobes:

Acinetobacter spp., Citrobacter freundii, Enterobacter spp., Hafnia alvei, Legionella pneumophila, Morganella morganii, Providencia spp., Pseudomonas spp., Serratia spp., Stenotrophomonas maltophilia, Yersinia enterocolitica.

Other:

Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia spp., Coxiella burnetii, Mycoplasma spp.

¹- for these microorganisms, the clinical efficacy of a combination of amoxicillin and clavulanic acid is shown.

²- strains of these bacteria do not produce beta-lactamases.Sensitivity to amoxicillin suggests a similar sensitivity to a combination of amoxicillin and clavulanic acid.

Pharmacokinetics:

After oral administration, both components are rapidly absorbed from the gastrointestinal tract (GIT). Absorption of active substances is optimal in case of taking the drug at the beginning of the meal. After oral administration of the suspension, 125 mg + 31.25 mg / 5 ml at a dose of 40 mg / kg time to reach the maximum concentration (TC_mOh) of amoxicillin is about 2 hours, the maximum concentration (C_mOh) of about 7 μg / ml. When administered to the suspension of 125 mg + 31.25 mg / 5 ml at a dose of 10 mg / kg TC_mOh clavulanic acid is about 1.6 h, C_mOh - about 2.7 μg / ml. After oral administration of the suspension, 200 mg + 28.5 mg at a dose of 45 mg / 6.4 mg / kg / day TS_mOh amoxicillin is 1-2 h, C_mOh about 12 μg / ml; TS_mOhclavulanic acid is 1-2 h, C_mOh about 5.5 μg / ml.

Therapeutic concentrations of amoxicillin and clavulanic acid are created in various organs and tissues, interstitial fluid (lungs, abdominal organs, fat, bone and muscle tissues, pleural, synovial and peritoneal fluids, skin, bile, purulent discharge, sputum).

Amoxicillin and clavulanic acid have a weak degree of binding to plasma proteins. Studies have shown that 25% of the total amount of clavulanic acid and 18% of amoxicillin bind to plasma proteins. Amoxicillin and clavulanic acid penetrate the placental barrier and are excreted in trace amounts with breast milk.

About 10-25% of the initial dose of amoxicillin is excreted by the kidneys in the form of inactive penicillic acid. Clavulanic acid in the human body undergoes intensive metabolism to 2,5-dihydro-4- (2-hydroxyethyl) -5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxybutan-2-one and is excreted by the kidneys, gastrointestinal tract and with exhaled air in the form of carbon dioxide. Like other penicillins, amoxicillin is excreted mainly by the kidneys, whereas clavulanic acid - through both renal and extrarenal mechanisms. Approximately 60-70% amoxicillin and about 40-65% clavulanic acid is excreted by the kidneys unchanged in the first 6 hours after administration. The half-life (T_1/2) of amoxicillin and clavulanic acid is 1-1.5 hours. In patients with severe renal insufficiency, T_1/2amoxicillin is increased to 7.5 hours, and for clavulanic acid - up to 4.5 hours. Both components are removed during hemodialysis and insignificant amounts - with peritoneal dialysis.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to a combination of amoxicillin and clavulanic acid:

- upper respiratory tract infections (including ENT diseases), eg, relapsing tonsillitis, sinusitis, otitis media, usually caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes;

- infections of the lower respiratory tract, for example exacerbations of chronic bronchitis, lobar pneumonia and bronchopneumonia, usually caused Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis;

- urinary tract infections, for example, cystitis, urethritis, pyelonephritis, infections of female genital organs, usually caused by species of the family Enterobacteriaceae (mainly Escherichia coli), Staphylococcus saprophyticus and species Enterococcus, as well as gonorrhea caused by Neisseria gonorrhoeae;

- infections of the skin and soft tissues, usually caused by Staphylococcus aureus, Streptococcus pyogenes and species Bacteroides;

- infections of bones and joints, for example, osteomyelitis, usually caused by Staphylococcus aureus, if necessary, long-term therapy;

- odontogenic infections, for example, periodontitis, odontogenic maxillary sinusitis, severe dental abscesses with spreading cellulitis;

- other mixed infections, for example, post-abortive sepsis, postpartum sepsis, intra-abdominal infections (as part of the stepwise therapy).

The sensitivity of bacteria to the combination of amoxicillin and clavulanic acid varies depending on the region and over time. Wherever possible, local sensitivity data should be taken into account.

Contraindications:

Hypersensitivity to amoxicillin, clavulanic acid, other components of the drug, beta-lactam antibiotics (for example, to penicillins and cephalosporins) in the anamnesis; previous episodes of jaundice or impaired liver function with amoxicillin / clavulanic acid in history; phenylketonuria; additional contraindications for dosage of 400 mg + 57 mg / 5 ml: children under 3 months of age and impaired renal function (creatinine clearance less than 30 ml / min).

Carefully:

Violation of the function of the liver.

Pregnancy and lactation:

In studies of reproductive function in animals, the combination of amoxicillin with clavulanic acid for oral and parenteral administration does not have a teratogenic effect.

In a single study in women with premature rupture of membranes, it was found that preventive therapy with amoxicillin / clavulanic acid combination may be associated with an increased risk of developing necrotizing enterocolitis in newborns. The drug is not recommended for use during pregnancy, except when the expected benefit to the mother exceeds the potential risk to the fetus.

The drug can be used during breastfeeding. Except for the risk of developing sensitization, diarrhea, or candidiasis of the oral mucosa associated with the penetration of trace amounts of the active components of this preparation into breast milk, no other adverse effects were observed in breast-fed infants. In case of adverse effects in children who are breastfeeding, it is necessary to stop breastfeeding.

Dosing and Administration:

For oral administration.

The dosage regimen is set individually depending on the age, body weight, function of the patient's kidneys, and also on the severity of the infection.

For optimal absorption and reduction of possible side effects from the gastrointestinal tract, it is recommended to take the drug at the beginning of the meal.

The minimum course of antibiotic therapy is 5 days. Treatment should not last more than 14 days without reviewing the clinical situation.

If necessary, it is possible to perform stepwise therapy (first parenteral administration of amoxicillin / clavulanic acid in the appropriate dosage form).

Adults and children over 12 years of age or weighing 40 kg or more

It is recommended to use other dosage forms of the combination amoxicillin / clavulanic acid.

Children aged 3 months to 12 years with a body weight of less than 40 kg

For the drug in a dose of 125 mg + 31.25 mg / 5 ml or 250 mg + 62.5 mg / 5 ml

Calculation of the dose is made depending on the age and body weight, indicate in mg / kg of body weight per day. The daily dose is divided into three doses every 8 hours. The recommended dosage regimen (dose calculation for amoxicillin) and the frequency of administration are shown in the table below.

	Suspension 4: 1 (125 mg + 31.25 mg / 5 mL or 250 mg + 62.5 mg / 5 mL) in 3 divided doses every 8 hours
Low doses	20 mg / kg / day
High doses	40 mg / kg / day

There is insufficient data to recommend the use of a dose of more than 40 mg / kg / day in three doses (4: 1 suspension) in children under 2 years of age.

For the drug in a dose of 400 mg + 57 mg / 5 ml

Calculation of the dose is made depending on the age and body weight, indicate in mg / kg of body weight per day. The daily dose is divided into two doses every 12 hours. The recommended dosage regimen (dose calculation for amoxicillin) and the frequency of administration are shown in the table below.

	Suspension 7: 1 (400 mg + 57 mg / 5 mL) in 2 divided doses every 12 hours
Low doses	25 mg / kg / day
High doses	45 mg / kg / day

There is insufficient data to recommend the use of a dose of more than 45 mg / kg / day in two divided doses (7: 1 suspension) in children under 2 years of age.

Low doses of the drug are recommended for the treatment of infections of the skin and soft tissues, as well as recurrent tonsillitis.

High doses of the drug are recommended for the treatment of diseases such as otitis media, sinusitis, lower respiratory tract infections and urinary tract infections, infections of bones and joints.

Children from birth to 3 months

Due to the immaturity of the excretory function of the kidneys, the recommended dose of the drug (calculation for amoxicillin) is 30 mg / kg / day in two divided doses as a 4: 1 suspension (125 mg + 31.25 mg / 5 ml or 250 mg + 62.5 mg / 5 ml).

The use of a suspension with a ratio of amoxicillin to clavulanic acid 7: 1 (400 mg + 57 mg / 5 ml) in this population it is contraindicated.

Children prematurely born

There are no recommendations regarding the dosage regimen.

Special patient groups

Patients with impaired renal function

Correction of the dosing regimen is based on the maximum recommended dose of amoxicillin and the value of creatinine clearance.

Creatinine clearance	Dosage regimen of the drug (suspension 4: 1 - 125 mg + 31.25 mg / 5 ml or 250 mg + 62.5 mg / 5 ml)
<30 ml / min	Correction of the dosing regimen is not required
10-30 ml / min	15 mg / 3.75 mg / kg 2 times a day, the maximum daily dose of 500 mg / 125 mg twice a day
<10 ml / min	15 mg / 3.75 mg / kg once a day, the maximum daily dose of 500 mg / 125 mg.

Patients on hemodialysis

Recommended dosage regimen: 15 mg / 3.75 mg / kg once a day. Before a hemodialysis session, one additional dose of 15 mg / 3.75 mg / kg should be taken. To restore the concentrations of the active components of the drug in blood plasma, it is necessary to take a second additional dose of 15 mg / 3.75 mg / kg after the hemodialysis session.

A 7: 1 suspension (400 mg + 57 mg / 5 mL) should be used only in patients with creatinine clearance greater than 30 mL / min, with no dosage adjustment required

Patients with hepatic impairment

Treat with caution; regularly monitor liver function. There is insufficient data to change the recommendation for doses in such patients.

Method of preparing the suspension

The suspension is prepared immediately before the first use.

Powder for the preparation of the suspension 125 mg + 31.25 mg / 5 ml: vigorously shake the bottle, add 90 ml of water in two doses (until the label), each time carefully shaking the bottle until the powder is completely dissolved.

Powder for the preparation of the suspension 250 mg + 62.5 mg / 5 ml: vigorously shake the bottle, add 80 ml of water in two doses (up to the mark), each time carefully shaking the bottle until the powder is completely dissolved.

Powder for the preparation of suspension 400 mg + 57 mg / 5 ml: vigorously shake the vial, add 57 ml of water in two doses (up to the mark) to obtain 70 ml of the finished suspension (for a 100 ml bottle) or 80 ml of water in two doses (up to a mark) to obtain 100 ml of the finished suspension (for a 120 bottle ml), each time carefully shaking the bottle until the powder is completely dissolved.

To prepare the suspension, it is recommended to dilute the powder with boiled water at room temperature.

It is recommended to store the ready suspension in the refrigerator.Before use, it is necessary to bring the suspension to room temperature (it is not recommended to heat the suspension).

Before each use, shake the vial with the finished suspension.

For precise dosing, the suspension is recommended to be measured with a measuring syringe with the risks included in the package. After each use, the syringe should be rinsed well with water.

For children under 2 years, the measured single dose of the suspension can be diluted with water in a ratio of 1: 1.

Side effects:

The undesirable reactions presented below are listed depending on the anatomophysiological classification and frequency of occurrence. Frequency of occurrence is defined as follows: very often (≥1 / 10), often (≥1 / 100 and <1/10), infrequently (≥1 / 1000 and <1/100); rarely (≥1 / 10000 and <1/1000), very rarely (<1/10000, including individual cases).

Infectious and parasitic diseases

Often: Candidiasis of the skin and mucous membranes.

Violations of the blood and lymphatic system

Rarely: reversible leukopenia (including neutropenia) and reversible thrombocytopenia.

Rarely: reversible agranulocytosis and reversible hemolytic anemia, prolongation of prothrombin time and bleeding time, anemia, eosinophilia, thrombocytosis.

Immune system disorders

Rarely: angioedema, anaphylactic reactions; a syndrome similar to serum sickness, allergic vasculitis.

Disturbances from the skin and subcutaneous tissues

Infrequently: skin rash, itching, hives.

Rarely: erythema multiforme.

Rarely: Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis.

Disturbances from the nervous system

Infrequently: dizziness, headache.

Rarely: convulsions (can be observed in patients with impaired renal function when taking high doses of the drug), insomnia, agitation, anxiety, behavior change, reversible hyperactivity.

Disorders from the gastrointestinal tract

Adults:

Often: diarrhea.

Often: nausea, vomiting.

Children:

Often: diarrhea, nausea, vomiting.

Total population:

Nausea most often occurred with the use of high doses of the drug.

Infrequently: indigestion.

Rarely: antibiotic-associated colitis (including pseudomembranous and hemorrhagic), gastritis, stomatitis, black hairy tongue, discoloration of the surface layer of tooth enamel in children.

Disturbances from the liver and bile ducts

Infrequently: moderate increase in activity of aspartate aminotransferase and / or alanine aminotransferase (ACT and / or ALT) (this reaction is observed in patients receiving beta-lactam antibiotic therapy, however, the clinical significance of this phenomenon is unknown).

Rarely: hepatitis and cholestatic jaundice (these reactions are observed in patients receiving penicillin antibiotics and cephalosporins), increased activity of alkaline phosphatase and / or bilirubin concentrations. These undesirable phenomena are very rare in children.

Side effects from the liver occur mainly in men and in elderly patients and can be associated with long-term therapy, usually occur during or shortly after treatment, but in some patients they develop only a few weeks after the end of treatment. Usually, side effects from the liver are reversible. It is extremely rare in patients with serious previous diseases or in those who have received potentially hepatotoxic drugs, they can be quite severe up to a lethal outcome.

Disorders from the kidneys and urinary tract

Rarely: interstitial nephritis, crystalluria, hematuria.

Overdose:

Symptoms: mainly from the gastrointestinal tract and disturbance of water-electrolyte metabolism. Amoxicillin crystalluria is described, in some cases leading to the development of renal failure. Cramps can occur in patients with impaired renal function, as well as in those who receive high doses of the drug.

Treatment: carrying out symptomatic therapy, normalization of water-electrolyte metabolism. Amoxicillin and clavulanic acid are removed from the blood by hemodialysis.

Children

In children, administration of amoxicillin in a dose of less than 250 mg / kg did not lead to significant clinical symptoms and did not require gastric lavage.

Interaction:

Simultaneous use of the drug and probenecid is not recommended. Probenecid reduces the tubular secretion of amoxicillin, and therefore simultaneous use of the drug and probenecid can lead to an increase in the concentration and persistence in the blood of amoxicillin, but not clavulanic acid.

The simultaneous use of allopurinol and amoxicillin may increase the risk of skin allergic reactions.Currently, there is no data in the literature on the simultaneous use of a combination of amoxicillin with clavulanic acid and allopurinol.

Penicillins can slow the excretion of methotrexate from the body by inhibiting its tubular secretion, so the simultaneous use of the drug and methotrexate may increase the toxicity of methotrexate.

The combination of amoxicillin with clavulanic acid, affecting the intestinal microflora, can lead to a decrease in the absorption of estrogens from the gastrointestinal tract, resulting in a decrease in the effectiveness of oral contraceptives.

In the literature, rare cases of an increase in the international normalized ratio (INR) in patients with simultaneous use of acenocoumarol or warfarin and amoxicillin are described. If simultaneous use of the drug with indirect anticoagulants is necessary, prothrombin time or INR should be carefully monitored during treatment and when the drug is withdrawn; may require correction of the dose of indirect anticoagulants.

In patients receiving mycophenolate mofetil, after the start of the combination of amoxicillin with clavulanic acid, a decrease in the concentration of the active metabolite, mycophenolic acid, was observed, before taking the next dose of the drug by approximately 50%. Changes in this concentration can not accurately reflect the overall changes in the exposure of mycophenolic acid.

Clavulanic acid can lead to nonspecific binding of immunoglobulin G and albumin with a cell membrane of erythrocytes, which can lead to a false positive reaction with a Coombs sample.

Special instructions:

Before starting treatment with the drug, you need to collect a detailed history of previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. Serious and sometimes fatal hypersensitivity reactions (anaphylactic reactions) to penicillins are described. The risk of occurrence of such reactions is highest in patients who have a history of hypersensitivity reactions to penicillins.

In case of an allergic reaction, it is necessary to stop treatment with the drug and begin the appropriate alternative therapy.

In severe reactions of hypersensitivity, you should immediately enter epinephrine. Oxygen therapy, intravenous glucocorticosteroids, and airway patency, including intubation, may also be required.

In the case of suspected infectious mononucleosis, the drug should not be used because patients with this disease amoxicillin can cause a skinlike skin rash, which makes it difficult to diagnose the disease.

Clavulanic acid can lead to nonspecific binding of immunoglobulin G and albumin with a cell membrane of erythrocytes, which can lead to a false positive reaction with a Coombs sample.

Long-term treatment with the drug may lead to excessive growth of insensitive microorganisms.

During prolonged therapy with the drug it is recommended to periodically evaluate the function of the kidneys, liver and hematopoiesis.

Cases of pseudomembranous colitis occur when antibacterial drugs are used, the severity of which can range from mild to life-threatening.Therefore, it is important to consider the possibility of developing pseudomembranous colitis in patients with diarrhea during or after using antibacterial drugs. If diarrhea is long and severe, or the patient experiences abdominal cramps, treatment should be discontinued and the patient should be examined. Contraindicated use of drugs that inhibit intestinal peristalsis.

If simultaneous use of the drug with indirect anticoagulants is necessary, prothrombin time or INR should be carefully monitored; may require correction of the dose of indirect anticoagulants.

In patients with impaired renal function, the dose of the drug should be reduced, respectively, the degree of impairment (see Section "Method of administration and dose").

In patients with reduced diuresis, crystalluria is very rare, mainly with parenteral therapy. During the administration of high doses of amoxicillin, it is recommended to take a sufficient amount of fluid and maintain an adequate diuresis to reduce the likelihood of amoxicillin crystals.

The high content of amoxicillin in the urine can lead to false positive results in the determination of glucose in the urine (for example, the Benedict test, Feeling's test).In this case, it is recommended to use a glucose oxidant method for determining the concentration of glucose in the urine.

The drug should be used with caution in patients with impaired liver function.

The severity of side effects from the gastrointestinal tract can be reduced by taking the drug at the beginning of the meal.

Oral care helps prevent tooth discoloration associated with taking the drug, as it is enough to brush your teeth.

Effect on the ability to drive transp. cf. and fur:

Since the combination of amoxicillin with clavulanic acid can cause dizziness, caution should be exercised when administering the drug while driving or other mechanisms.

Form release / dosage:

Powder for the preparation of a suspension for oral administration, 125 mg + 31.25 mg / 5 ml; 250 mg + 62.5 mg / 5 ml; 400 mg + 57 mg / 5 ml.

Packaging:

Powder for the preparation of a suspension for oral administration, 125 mg + 31.25 mg / 5 ml: 11.66 g of powder in a bottle of 120 ml dark glass, sealed with a PVP stopper and a screw cap made of aluminum with a control of the first opening. For 1 bottle together with instructions for medical use and a measuring cup made of PVP or a dosing syringe made of PVP in a cardboard bundle.

Powder for suspension for oral administration, 250 mg + 62.5 mg / 5 ml: 15,80 g powder in a bottle of dark glass with a volume of 120 ml, sealed with a PVP stopper and a screw cap made of aluminum with a control of the first opening. For 1 bottle together with instructions for medical use and a measuring cup made of PVP or a dosing syringe made of PVP in a cardboard bundle.

Powder for suspension for oral administration, 400 mg + 57 mg / 5 ml:

- 15.40 grams of powder in a 100 ml glass vial, sealed with a PVP stopper and screwed aluminum cover, with the control of the first opening. For 1 bottle together with instructions for medical use and a measuring cup made of PVP or a dosing syringe made of PVP in a cardboard bundle.

- on 22.0 g of powder in a bottle of dark glass with a volume of 120 ml, sealed with a PVP stopper and a screw cap made of aluminum with a control of the first opening. For 1 bottle together with instructions for medical use and a measuring cup made of PVP or a dosing syringe made of PVP in a cardboard bundle.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

The prepared suspension should be stored in a refrigerator, at a temperature of +2 to +8 ° C in a tightly closed vial.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use the product after the expiry date printed on the package.

Shelf life of the prepared suspension is 7 days.

Terms of leave from pharmacies:On prescription

Registration number:LP-003951

Date of registration:09.11.2016

Expiration Date:09.11.2021

The owner of the registration certificate:Micro Labs LimitedMicro Labs Limited India

Manufacturer: & nbsp

MICRO LABS, Limited India

Representation: & nbspMICRO LABS LIMITED MICRO LABS LIMITED India

Information update date: & nbsp10.12.2016

Illustrated instructions

Instructions

Bactoklave® (Bactoclav®)