Linezolid-Vial - instructions for use, dose, side effects, contraindications

Excipients: corn starch - 136,80 mg, cellulose microcrystalline - 110,00 mg, sodium carboxymethyl starch (type A) 16.80 mg, croscarmellose sodium 11.00 mg, magnesium stearate 8,80 mg, talc 8.52 mg, silicon dioxide colloid 7.00 mg , methyl parahydroxybenzoate 0.90 mg, propyl parahydroxybenzoate 0.18 mg;

Sheath:

Film coating Color Coat FH4S-H, White color (hypromellose 15 cp 9.45 mg, dibutyl sebacate 2.65 mg, hypromellose 5 cp 1.89 mg, silicon colloidal dioxide 1.14 mg, titanium dioxide -2.14 mg, talc 2.73 mg, ) - 20.00 mg.

Description:

Biconvex tablets of oblong form, covered with film shell white or almost white, with a risk on one side; On the cross-section, the core is white or almost white.

Pharmacotherapeutic group:Antibiotic-oxazolidinone

ATX: & nbsp

J.01.X.X.08 Linezolid

J.01.X.X Other antibacterial drugs

Pharmacodynamics:

Synthetic antibacterial drug, oxazolidinone. Selectively suppresses protein synthesis in bacteria by binding to bacterial ribosomes and preventing the formation of a functional initiating complex 70S, which is an important component of the translation process in protein synthesis.

Active in vitro and in vivo in a relationship:

Gram-positive aerobes: Enterococcus faecium (including strains resistant to vancomycin), Staphylococcus aureus (including methicillin-resistant strains), Streptococcus agalactiae, Streptococcus pneumoniae (including multidrug-resistant strains), Streptococcus pyogenes.

Active in vitro in a relationship:

Gram-positive aerobes - Enterococcus faecalis (including strains resistant to vancomycin); Enterococcus faecium (including strains sensitive to vancomycin); Staphylococcus epidermidis (including methicillin-resistant strains); Staphylococcus haemolyticus, Streptococcus spp. groups viridans; gram-negative aerobes - Pasteurella multocida.

Resistant to linezolid microorganisms - Haemophilus influenzae, Moraxella catarrhalis, Neisseria spp., Enterobacteriaceae spp., Pseudomonas spp.

Gram-positive aerobes - Enterococcus faecalis (including strains resistant to vancomycin), Enterococcus faecium (strains sensitive to vancomycin), Corynebacterium jeikeium, Enterococcus casseliflavus, Enterococcus gallinarum, Listeria monocytogenes, Staphylococcus aureus (including methicillin-resistant strains), Staphylococcus aureus (strains with intermediate sensitivity to glycopeptides), Staphylococcus epidermidis (including methicillin-resistant strains), Staphylococcus haemolyticus, Streptococcus agalactiae, Streptococcus intermedius, Streptococcus pneumoniae (including strains with intermediate sensitivity to penicillin and penicillin-resistant strains), Streptococcus spp. (group C streptococcus and G), Streptococcus pyogenes, Streptococcus viridans.

Gram-negative aerobes - Pasteurella multocida, Pasteurella canis.

Anaerobic Gram-positive bacteria - Clostridium perfringens, Peptostreptococcus spp. (incl. Peptostreptococcus anaerobius).

Anaerobic Gram-negative bacteria - Bacteroides fragilis, Prevotella spp.; Chlamydia pneumoniae.

The drug is moderately sensitive Legionella spp., Mycoplasma spp.

Resistant to linezolid microorganisms - Haemophilus influenzae, Moraxella catarrhalis, Neisseria spp., Enterobacteriaceae spp., Pseudomonas spp.

Cross-resistance between linezolid and antimicrobials of other classes (eg, aminoglycosides, beta-lactam antibiotics, folic acid antagonists, glycopeptides, lincosamides, quinolones, rifampicins, tetracyclines and chloramphenicol) is not present. Linezolid is active against pathogenic microorganisms, both sensitive and resistant to these drugs. Resistance to linezolid develops very slowly through a multistage mutation 23S ribosomal RNA at a frequency less than 1x10^-9- 1x10^-11.

Pharmacokinetics:

Suction.

Absorption is high. Food intake does not affect the degree of absorption. Absolute bioavailability is about 100%. After a single dose of 600 mg and after taking 2 times a day, the maximum concentration of linezolid in the blood plasma (C_max) - 12.7 μg / ml and 21.2 μg / ml, respectively. The time to reach the maximum concentration (TC_max) - 1.28 and 1.03 h; the area under the pharmacokinetic curve "concentration-time" (AUC) - 91.4 and 138 μg / h / ml; half-life (T_1/2) - 4.26 and 5.4 h; clearance - 127 and 80 ml / min. The equilibrium concentration (C_ss) of the drug in the blood is achieved on the 2nd day of application.

Distribution.

Rapidly distributed in tissues with good blood supply. The volume of distribution upon reaching C_ss in a healthy adult averages 40-50 liters. The connection with plasma proteins is 31% and does not depend on the concentration of linezolid in the blood.

Metabolism.

It has been established that isoenzymes of the cytochrome P450 system do not participate in the metabolism of linezolid in vitro. Linezolid does not inhibit or potentiate the activity of clinically important isoenzymes of the cytochrome P450 system (1A2, 2C9, 2C19, 2D6, 2E1, 3A4). Metabolic oxidation leads to the formation of two inactive metabolites - hydroxyethyl glycine (the main metabolite in humans, formed as a result of a non-enzymatic process) and aminoethoxyacetic acid (formed in smaller amounts). Other inactive metabolites are also described.

Excretion.

The extrarenal clearance is about 65% of the linezolid clearance. Linezolid in patients with normal renal function and with renal insufficiency of mild and moderate severity is excreted by the kidneys in the form of hydroxyethyl glycine (40%), aminoethoxyacetic acid (10%) and unchanged (30-35%).The intestine is excreted as hydroxyethyl glycine (6%) and aminoethoxyacetic acid (3%). Linezolid in an unmodified form is practically not excreted by the intestine.

Pharmacokinetics in selected patient groups

Patients with renal insufficiency. After a single dose of 600 mg of linezolid in patients with severe renal insufficiency (creatinine clearance <30 ml / min), the plasma concentration of two major metabolites increases by 7-8 times. However, increases AUC linezolid is not observed. Despite the fact that some basic metabolites are removed during hemodialysis, their concentration in the blood plasma after taking 600 mg of linezolid and carrying out the dialysis procedure remains significantly higher than the concentration in the blood plasma in patients with normal kidney function, mild or moderate renal insufficiency.

Patients with hepatic insufficiency. There is limited evidence that the pharmacokinetics of linezolid and its two major metabolites do not change in patients with mild to moderate hepatic insufficiency (class A and B according to the Child-Pugh classification). The pharmacokinetics of linezolid in patients with severe hepatic insufficiency (class C according to the Child-Pugh classification) has not been studied. However, since linezolid it is not metabolized by a non-enzyme route, it is not expected to significantly impair its metabolism in liver failure.

Children and teens. In adolescents (12-17 years old), the pharmacokinetics of linezolid, taken at a dose of 600 mg, does not differ from the kinetics in adults. Thus, when 600 mg of linezolid is used in adolescents every 12 hours, its plasma concentration will be the same as in adults when administered in the same dose.

Elderly. In elderly patients aged 65 years and older, the pharmacokinetics of linezolid do not change significantly.

Women. Women have lower distribution and clearance (20% less) and a higher plasma concentration than men. T_1/2 linezolid in women and men is not significantly different, so there is no need to adjust the dosage regimen.

Indications:

Treatment of infectious and inflammatory diseases, if known or suspected, that they are caused by linezolid-sensitive aerobic and anaerobic Gram-positive microorganisms (including infections accompanied by bacteremia):

- community-acquired pneumonia caused by Streptococcus pneumoniae (including multidrug-resistant strains), including cases accompanied by bacteraemia, or Staphylococcus aureus (only methicillin-sensitive strains);

- hospitalized pneumonia caused by Staphylococcus aureus (including methicillin-sensitive and methicillin-resistant strains) or Streptococcus pneumoniae (including multidrug-resistant strains);

- complicated infections of the skin and soft tissues, including infections with diabetic foot syndrome, not accompanied by osteomyelitis, caused by Staphylococcus aureus (including methicillin-sensitive and methicillin-resistant strains), Streptococcus pyogenes or Streptococcus agalactiae;

- uncomplicated skin and soft tissue infections caused by Staphylococcus aureus (only methicillin-sensitive strains) or Streptococcus pyogenes;

- infections caused by vancomycin-resistant Enterococcus faecium, including those accompanied by bacteremia.

Contraindications:

- Hypersensitivity to linezolid and other components of the drug.

- Simultaneous reception of linezolid with drugs that inhibit monoamine oxidases (MAO) A and B (for example, phenelzine, isocarboxazide), and also within two weeks after stopping the intake of such drugs.

In the absence of careful monitoring of patients and monitoring of blood pressure, linezolid should not be prescribed:

- patients with uncontrolled arterial hypertension, pheochromocytoma, thyrotoxicosis, carcinoid syndrome, bipolar disorder, schizoaffective disorder and acute confusion;

- patients receiving the following types of drugs: adrenomimetics (for example, pseudoephedrine, phenylpropanolamine, epinephrine, norepinephrine, dobutamine), dopaminomimetics (eg, dopamine), serotonin reuptake inhibitors, tricyclic antidepressants, agonists 5-HT₁ receptors (triptans), meperidine, or buspirone.

- children under 12 years (for this dosage form).

Carefully:

Patients with renal insufficiency

Due to the unexplained clinical significance of the two primary metabolites of linezolid in patients with severe renal failure, linezolid should be applied with caution in such patients, and only if the intended benefit exceeds the potential risk. There is also no data on the use of linezolid in patients on ambulatory peritoneal dialysis or other alternative methods of treating renal failure.

Patients with hepatic insufficiency

There are limited clinical data that recommend the use of linezolid in such patients only if the intended benefit exceeds the potential risk. Linezolid should be used with caution in patients with systemic infections posing a risk to life, such as those associated with venous catheters in intensive care units.

Pregnancy and lactation:

There were no studies of the safety of linezolid in pregnancy. The use of linezolid in pregnancy is possible only if the intended benefit from therapy for the mother exceeds the potential risk to the fetus.

It is not known whether linezolid in breast milk. If necessary, use during lactation should stop breastfeeding.

Dosing and Administration:

Inside. The drug can be taken as during meals, and between meals. Patients who at the beginning of therapy linezolid It was prescribed intravenously, in the future it can be transferred to any dosage form of linezolid for oral administration. the bioavailability of linezolid upon ingestion is almost 100%.

Adults and children over 12 years of age: 600 mg every 12 hours.

The duration of treatment depends on the pathogen, the localization and severity of the infection, and also on the clinical effect.

Recommended duration:

Community-acquired pneumonia caused by Streptococcus pneumoniae (including multidrug-resistant strains), including cases accompanied by bacteraemia, or Staphylococcus aureus (only methicillin-sensitive strains) - 10-14 days;

Hospital pneumonia caused by Staphylococcus aureus (including methicillin-sensitive and methicillin-resistant strains) or Streptococcus pneumoniae (including multidrug resistant strains) - 10-14 days;

Complicated infections of the skin and soft tissues, including infections with diabetic foot syndrome, not accompanied by osteomyelitis, caused by Staphylococcus aureus (including methicillin-sensitive and methicillin-resistant strains), Streptococcus pyogenes or Streptococcus agalactiae - 10-14 days;

Uncomplicated skin and soft tissue infections caused by Staphylococcus aureus (only methicillin-sensitive strains) or Streptococcus pyogenes - 10-14 days;

Infections caused by vancomycin-resistant Enterococcus faecium, including those accompanied by bacteremia - 14-28 days.

Older patients: correction of the dose is not required.

Patients with impaired hepatic function: correction of the dose is not required.

Patients with impaired renal function: correction of the dose is not required. Due to the fact that 30% of linezolid is removed during hemodialysis within 3 hours, linezolid should be taken after dialysis to patients who need it.

Side effects:

The incidence of adverse events listed below was determined according to the following (World Health Organization classification): very often (≥ 1/10), often (≥ 1/100 - <1/10), infrequently (≥ 1/1000 - <1/100), rarely (≥ 1/10000 - <1/1000), very rarely (<1/10000), the frequency is unknown (according to available data to estimate the frequency of development is impossible).

The undesirable phenomena associated with the use of linezolid are usually of mild or moderate severity. More often than others the diarrhea, a headache, a nausea, vomiting are marked.

Adult patients

Infectious and parasitic diseases: often - candidiasis (including candidiasis of the oral cavity, vaginal candidiasis), fungal infections; infrequently - vaginitis; rarely - colitis, caused by the use of antibiotics (including pseudomembranous colitis).

Violations from the blood and lymphatic system: often - anemia; infrequently - leukopenia, neutropenia. thrombocytopenia, eosinophilia; rarely - pancytopenia; frequency unknown - myelosuppression, sideroblastic anemia.

Immune system disorders: frequency is unknown - anaphylaxis.

Disorders from the metabolism and nutrition: infrequently - hyponatremia; frequency is unknown - lactic acidosis.

Disorders of the psyche: often - insomnia.

Impaired nervous system: often - headache, perversion of taste ("metallic" taste in the mouth), dizziness; infrequently - convulsions, hyposthenia, parasthesia; frequency is unknown - serotonin syndrome, peripheral neuropathy.

Disorders from the side of the organ of vision: infrequently - blurred vision; rarely appearance defects in the fields of vision; frequency unknown - neuropathy of the optic nerve, optic neuritis, loss of vision, changes in visual acuity, change in color vision.

Hearing disorders and labyrinthine disturbances: infrequent - ringing in the ears.

Disorders from the cardiovascular system: often - increased blood pressure; infrequently - arrhythmia (tachycardia), transient ischemic attack, phlebitis, thrombophlebitis.

Disorders from the gastrointestinal tract: often - diarrhea, nausea, vomiting, localized or diffuse pain in the abdomen, constipation, indigestion; infrequently - pancreatitis, gastritis, bloating, dry mouth, glossitis, loose stools, stomatitis,change in the color of the tongue mucosa and other disorders of the language; rarely - a superficial change in the color of the enamel of the teeth.

Disorders from the liver and bile ducts: often - changes in the results of functional liver tests, increased activity of "liver" enzymes (including alanine aminotransferase (ALT), aspartate aminotransferase (ACT), alkaline phosphatase (AFP)); infrequently, an increase in the concentration of total bilirubin.

Disturbances from the skin and subcutaneous tissues: often - itching, rash; infrequently - hives, dermatitis, excessive sweating; frequency unknown - bullous skin lesions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis), angioedema, alopecia.

Disorders from the kidneys and urinary tract: often - increased blood urea concentration; infrequently - renal insufficiency, increase in the concentration of creatinine in the blood plasma, polyuria.

Violations of the genitals and breast: infrequently - violations of the vagina and vulva.

General disorders and disorders at the site of administration: often - fever, localized pain; infrequently - chills, weakness, thirst.

Laboratory indicators: Increasing the number of neutrophils, eosinophils, reducing hemoglobin, hematocrit or red blood cell number, increasing or decreasing the number of platelets or leukocytes, increasing the activity of lactate dehydrogenase, creatine kinase, lipase, amylase, increasing fasting glucose, reducing total protein, albumin, sodium or calcium, increase or decrease of potassium or bicarbonates; infrequent - an increase in the content of sodium or calcium in the blood plasma, a decrease in glucose concentration not fasting, an increase or decrease in blood chlorides, an increase in the number of reticulocytes, a decrease in the number of neutrophils.

The following side effects with linezolid in rare cases were classified as serious: localized abdominal pain, transient ischemic attack, arterial hypertension.

In controlled clinical trials in which linezolid was used for a maximum of 28 days, only 2% of the patients developed anemia. In another study among patients with life-threatening infections, 2.5% (33/1326) of patients who received linezolid less than 28 days, anemia developed, while with linezolid for more than 28 days anemia developed in 12.3% (53/430) patients. The proportion of cases of development of anemia requiring a blood transfusion was 9% among patients receiving linezolid less than 28 days (3/33), and 15% (8/53) in those cases where linezolid used more than 28 days.

Side effects in children do not differ from those in adult patients.

Overdose:

No cases of overdose of linezolid were reported.

Treatment: recommended symptomatic therapy (including the need to maintain the rate of glomerular filtration). There is no data on the acceleration of deducing linezolid in peritoneal dialysis or hemoperfusion. Approximately 30% of the dose is excreted within 3 hours of hemodialysis.

Interaction:

It is established that cytochrome P450 isoenzymes do not participate in the metabolism of linezolid in vitro. Linezolid does not inhibit or potentiate the activity of clinically important cytochrome P450 isoenzymes (1A2, 2C9, 2C19, 2D6, 2E1, 3A4). Thus, no CD450-induced interaction is expected with linezolid. With simultaneous use of linezolid and (8) -varpharin, which is largely metabolized by isoenzyme CYP2C9, pharmacokinetic characteristics of warfarin do not change. Such drugs as warfarin and phenytoin, which are the substrates of the isoenzyme CYP2C9, can be used simultaneously with linezolid without dose adjustment.

Inhibitors of monoamine oxidase

Linezolid is a non-selective reversible inhibitor of monoamine oxidase, therefore, in some patients receiving linezolid, there may be a moderate reversible increase in the pressor action of pseudoephedrine and phenylropanolamine. In this regard, it is recommended to reduce the initial doses of the following groups of drugs: adrenomimetics (for example, pseudoephedrine, phenylpropanolamine, epinephrine, norepinephrine, dobutamine), dopaminomimetics (for example, dopamine) and subsequently to carry out the dose selection by titration.

In studies, there was no development of serotonin syndrome in patients who received linezolid together with serotonergic drugs. However, there were several reports about the development of serotonin syndrome during treatment with linezolid and antidepressants - selective serotonin reuptake inhibitors.

With simultaneous use with aztreonam and gentamycin, there was no change in the pharmacokinetics of linezolid.

Rifampicin caused a decrease C_max and AUC of linezolid on average by 21% and 32%, respectively.

Special instructions:

In an open study among critically ill patients with intravascular catheter-related infections were observed excess mortality in patients treated with linezolid, Compared with patients who received vancomycin / dicloxacillin / oxacillin [78/363 (21.5%) vs. 58/363 (16.0%)]. The main factor influencing mortality was the gram-positive pathogen of infection at the initial stage. The mortality rate was similar among patients whose infections were caused only by Gram-positive microorganisms, but was significantly higher in the linezolid group when other microorganisms were detected or could not be detected at the initial stage. The greatest imbalance was noted during treatment and within 7 days after the end of antibiotic therapy. In many patients linezolid groups were detected during the study of Gram-negative microorganisms, and they died from infection caused by Gram-negative microorganisms or polymicrobial infections. Thus, in case of complicated infections of the skin and soft tissues, linezolid should be used in patients with known or possible co-infection with gram-negative microorganisms,if there are no alternative treatment options. In these cases, simultaneous additional use of drugs acting on gram-negative microflora is shown.

In some patients taking linezolid, reversible myelosuppression may develop (with anemia, thrombocytopenia, leukopenia and pancytopenia), depending on the duration of therapy. In elderly patients, the risk of developing this condition is also increased. Thrombocytopenia occurred more often in patients with severe renal failure, regardless of the patient's hemodialysis. In connection with this, during the treatment it is necessary to monitor blood values in patients with an increased risk of bleeding, myelosuppression in the anamnesis, simultaneous use of drugs that reduce hemoglobin or the number of platelets and / or their functional properties, with severe renal failure, as well as in patients taking linezolid more than 2 weeks. Linezolid these patients are only used when it is possible to carefully monitor the level of hemoglobin, the number of leukocytes and platelets.If during treatment with linezolid develops marked myelosuppression, treatment should be discontinued unless continuation of therapy is considered absolutely necessary. In this case, intensive monitoring of blood counts and appropriate treatment is necessary. In addition, it is recommended that a blood test (including the determination of hemoglobin level, platelet count and leukocyte count (with calculation of the leukocyte formula) be performed weekly in patients receiving linezolid regardless of the initial blood test. A higher incidence of severe anemia was observed in patients who received linezolid more than the maximum recommended duration of 28 days. These patients were more likely to require a blood transfusion. Cases of sideroblastic anemia were registered in the post-marketing period. In most cases, the duration of linezolid therapy exceeded 28 days. In most patients, the manifestations were completely or partially reversible after discontinuation of treatment with linezolid with / without specific treatment for anemia.

In patients taking antibacterial drugs, including linezolid, should take into account the risk of developing pseudomembranous colitis of varying severity. About cases of diarrhea associated with Clostridium difficile, was reported in connection with the use of almost all antibacterial drugs, including linezolid. The severity of diarrhea can range from mild to severe forms. Treatment with antibacterial drugs disrupts the normal intestinal microflora, which leads to excessive growth Clostridium difficile. Clostridium difficile produces toxins A and B, which lead to the development of diarrhea associated with Clostridium difficile. Excessive amount of toxins produced by strains Clostridium difficile, may cause an increase in mortality among patients, since such infections can be resistant to antimicrobial therapy, and may require a colonectomy. The possibility of developing diarrhea associated with Clostridium difficile, should be considered in all patients with diarrhea, followed by the use of antibiotics. Careful medical supervision for 2 months is necessary for patients who have had diarrhea associated with Clostridium difficile after the introduction of antibacterial drugs. If pseudomembranous colitis is confirmed or suspected, antibacterial drugs that do not have activity against FROM. difficile, it is necessary to cancel and prescribe a specific therapy.Drugs that inhibit the intestinal peristalsis are contraindicated.

If symptoms of visual impairment such as changes in visual acuity, changes in color perception, fogging, visual field defects are advisable, it is recommended that an ophthalmologist be consulted urgently. linezolid for a long time (more than 28 days), as well as for all patients with newly appeared symptoms of visual disturbances, regardless of the duration of therapy.

In the case of peripheral neuropathy and optic nerve neuropathy, the risk / benefit ratio of linezolid therapy in these patients should be assessed. The risk of developing neuropathy is higher if linezolid It is used in patients who are currently using or who have recently taken antimycobacterial drugs for the treatment of tuberculosis.

In connection with the use of linezolid, lactoacidosis was reported. Patients who, with the use of linezolid, experience repeated nausea or vomiting, abdominal pain, unexplained acidosis, or a decrease in the concentration of hydrocarbonate anions,require careful monitoring by the doctor.

Linezolid inhibits the synthesis of the mitochondrial protein. Side effects, such as, lactic acidosis, anemia and neuropathy (peripheral or optic nerve), can result from this inhibition; these effects are more common when the drug is used more than 28 days.

Cramping was reported in patients taking linezolid, and in most cases in the history there was an indication of convulsions or the presence of risk factors for their development. Patients need to collect a detailed history of previous episodes of seizures.

If the drug is to be used in combination with selective serotonin reuptake inhibitors, patients should be constantly monitored to identify signs and symptoms of serotonin syndrome, such as cognitive impairment, hyperpyrexia, hyperreflexia and impaired coordination of movements. If these symptoms appear, you should cancel one or both of the drugs taken. When discontinuing the use of a serotonergic drug, symptoms of the withdrawal syndrome may be observed.

There have been reports of reversible surface changes in tooth enamel staining with linezolid. These changes in staining were removed by professional dental cleaning.

There were reported cases of symptomatic hypoglycemia in patients with diabetes mellitus who received linezolid simultaneously with insulin or hypoglycemic drugs. Although a causal relationship between the use of linezolid and the development of hypoglycemia not established, patients with diabetes should be warned about the possibility of developing hypoglycemia. In case of hypoglycaemia, correction of insulin dose / hypoglycemic drugs or cancellation of linezolid is necessary.

Patients should be advised not to take large amounts of food containing tyramine (such as red wine, old cheese, some alcoholic drinks, smoked meat).

Clinical studies that studied the effect of linezolid on the normal microflora of the human body were not carried out.

The use of antibacterial drugs can sometimes lead to an increased growth of microorganisms that are not susceptible to it.In clinical studies, it was shown that approximately 3% of patients receiving recommended doses of linezolid developed candidiasis associated with taking antibiotics. If superinfections occur against the background of linezolid, appropriate medical measures should be taken.

The safety and efficacy of linezolid for more than 28 days have not been established.

In controlled clinical trials, patients with "diabetic foot" syndrome, bedsores or ischemic impairment, severe burns or gangrenous lesions did not participate. Thus, the experience of using linezolid in the therapy of these conditions is limited.

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

During treatment with linezolid, it is not recommended to operate vehicles, mechanisms or engage in activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Film-coated tablets, 600 mg.

Packaging:

For 10 tablets in a PVC blister / aluminum foil; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 blisters in a pack of cardboard along with instructions for use.

50 tablets per container polymer with a screw cap; one container together with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

3 years. Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-003882

Date of registration:05.10.2016

Expiration Date:05.10.2021

The owner of the registration certificate:VIAL, LLC VIAL, LLC Russia

Manufacturer: & nbsp

PROTECH BIOSYSTEMS, PVT. Ltd. India

Information update date: & nbsp05.04.2018

Illustrated instructions

Instructions

Linezolid-Vial (Linezolid-Vial)