Azithromycin-pharmex

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT AZITHROMYCIN-PHARMEX (AZITHROMYCIN-PHARMEX)

Composition:

Active substance: azithromycin;

1 vial contains 500 mg of azithromycin (as azithromycin dihydrate);

Excipients: citric acid monohydrate, sodium hydroxide.

Pharmaceutical form. Lyophilisate for solution for infusion.

Main physicochemical properties: lyophilized porous mass of white or almost white color.

Pharmacotherapeutic group.

Antibacterials for systemic use.

Macrolides, lincosamides and streptogramins. Azithromycin. ATC code J01FA10.

Pharmacological properties.

Pharmacodynamics.

Azithromycin is a macrolide antibiotic belonging to the azalide group. The molecule is formed by insertion of a nitrogen atom into the lactone ring of erythromycin A. The mechanism of action of azithromycin involves inhibition of bacterial protein synthesis by binding to the 50S ribosomal subunit and suppression of peptide translocation.

Mechanism of resistance.

Complete cross-resistance exists among Streptococcus pneumoniae, beta-hemolytic streptococcus group A, Enterococcus faecalis, and Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus (MRSA), to erythromycin, azithromycin, and other macrolides and lincosamides.

Macrolides administered intravenously are active against Legionella pneumophila. Macrolides are used in the treatment of infections caused by Campylobacter jejuni. Azithromycin is used to treat infections caused by S. typhi and Shigella spp.

The prevalence of acquired resistance may vary depending on geographical location and time for isolated species; therefore, local information on resistance patterns is necessary, especially when treating severe infections. Expert advice should be sought if local resistance prevalence renders the efficacy of the drug questionable for at least some types of infections.

Antimicrobial spectrum of azithromycin

Staphylococcus aureus resistant to methicillin has a very high prevalence of acquired resistance to macrolides and is mentioned here due to its rare susceptibility to azithromycin.

Pharmacokinetics.

In patients with community-acquired pneumonia who received daily 500 mg intravenous infusions of azithromycin over 1 hour at a concentration of 2 mg/mL, the mean maximum concentration (C_max) ± standard deviation (SD) was 3.63±1.6 µg/mL, while the trough concentration (at 24 hours) was 0.2±0.15 µg/mL, and the area under the concentration-time curve (AUC) was 9.6±4.8 µg·h/mL.

In healthy volunteers who received a 500 mg intravenous infusion of azithromycin over 3 hours at a concentration of 1 mg/mL, the mean C_max ± SD, trough concentration (at 24 hours), and AUC were 1.14±0.14 µg/mL, 0.18±0.02 µg/mL, and 8.03 µg·h/mL, respectively.

After oral administration, significantly higher levels of azithromycin were found in various tissues such as lungs, tonsils, or prostate, where azithromycin concentrations were up to 50 times higher than in blood plasma. High concentrations of azithromycin were detected in genital tissue 96 hours after a single 500 mg oral dose.

The mean volume of distribution is approximately 30 L/kg. The elimination half-life is 2–4 days in both blood plasma and tissues.

Metabolism occurs via demethylation, hydroxylation, and hydrolysis.

Plasma clearance is approximately 600 mL/min. The primary route of elimination of azithromycin is via the liver. High concentrations of unchanged drug have been found in bile, along with several microbiologically inactive metabolites. Approximately 12% of the intravenously administered dose was excreted unchanged in urine within 3 days after administration, mostly within the first 24 hours.

There are no data indicating changes in the pharmacokinetics of azithromycin in patients with mild renal impairment (creatinine clearance > 40 mL/min) compared to patients with normal renal function. Pharmacokinetic data on the use of azithromycin in patients with severe renal impairment are lacking.

No differences in pharmacokinetics have been observed in mild to moderate hepatic dysfunction.

Clinical characteristics.

Indications.

Infections requiring initial intravenous therapy caused by microorganisms sensitive to azithromycin:

• Community-acquired pneumonia;
• Pelvic inflammatory disease.

Contraindications.

Hypersensitivity to azithromycin, erythromycin, or to any macrolide or ketolide antibiotic, or to any other component of the medicinal product.

Due to the theoretical possibility of ergotism, azithromycin should not be administered concurrently with ergot derivatives.

Interaction with other medicinal products and other forms of interaction.

Azithromycin should be administered with caution in patients receiving other medicinal products that may prolong the QT interval.

Antacids. In studies evaluating the effect of concomitant antacid administration on the pharmacokinetics of azithromycin, no overall changes in bioavailability were observed, although plasma peak concentrations of azithromycin were reduced by approximately 25%. Azithromycin should be taken at least 1 hour before or 2 hours after antacid administration.

Cetirizine. In healthy volunteers, co-administration of azithromycin for 5 days with cetirizine 20 mg at steady state did not reveal any pharmacokinetic interaction or significant changes in the QT interval.

Didanosine. Concurrent administration of daily doses of 1200 mg azithromycin with didanosine showed no effect on the pharmacokinetics of didanosine compared to placebo.

Digoxin and colchicine. It has been reported that concomitant use of macrolide antibiotics, including azithromycin, and P-glycoprotein substrates such as digoxin and colchicine, may lead to increased serum levels of the P-glycoprotein substrate. Therefore, when azithromycin is administered concomitantly with digoxin, the potential for increased digoxin concentrations should be considered, and digoxin levels should be monitored.

Zidovudine. Single doses of 1000 mg and 1200 mg, or multiple doses of 600 mg azithromycin, did not affect the plasma pharmacokinetics or urinary excretion of zidovudine or its glucuronide metabolites. However, azithromycin increased the concentration of phosphorylated zidovudine, the clinically active metabolite, in peripheral blood mononuclear cells. The clinical significance of these findings is unclear but may be beneficial for patients.

Ergot derivatives. Due to the theoretical possibility of ergotism, concomitant administration of azithromycin with ergot derivatives is not recommended.

Azithromycin has no significant interaction with the hepatic cytochrome P450 system. It is considered that the drug does not exhibit the pharmacokinetic drug interactions observed with erythromycin and other macrolides. Azithromycin does not cause induction or inactivation of hepatic cytochrome P450 via a cytochrome-metabolite complex.

Studies have been conducted on the co-administration of azithromycin with the following medicinal products, whose metabolism is largely mediated by cytochrome P450.

Atorvastatin. Concomitant administration of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not alter atorvastatin plasma concentrations (based on analysis of HMG-CoA reductase inhibition). However, cases of rhabdomyolysis have been reported in the post-marketing period in patients receiving azithromycin with statins.

Carbamazepine. In a pharmacokinetic interaction study in healthy volunteers, azithromycin did not show a significant effect on plasma levels of carbamazepine or its active metabolites.

Cimetidine. In a pharmacokinetic study assessing the effect of a single dose of cimetidine administered 2 hours before azithromycin on azithromycin pharmacokinetics, no changes in azithromycin pharmacokinetics were observed.

Oral coumarin-type anticoagulants. In a pharmacokinetic interaction study, azithromycin did not alter the anticoagulant effect of a single 15 mg dose of warfarin in healthy volunteers. There have been reports of potentiation of the anticoagulant effect following concomitant administration of azithromycin and oral coumarin-type anticoagulants. Although a causal relationship has not been established, frequent monitoring of prothrombin time should be considered when prescribing azithromycin to patients receiving oral coumarin-type anticoagulants.

Cyclosporine. In a pharmacokinetic study involving healthy volunteers who received an oral dose of azithromycin 500 mg/day for 3 days followed by a single oral dose of cyclosporine 10 mg/kg, a significant increase in Cmax and AUC0-5 of cyclosporine was demonstrated. Therefore, caution should be exercised when administering these drugs concomitantly. If combination therapy is considered justified, careful monitoring of cyclosporine levels and appropriate dose adjustments are necessary.

Efavirenz. Concomitant administration of a single 600 mg dose of azithromycin with 400 mg efavirenz daily for 7 days did not result in any clinically significant pharmacokinetic interaction.

Fluconazole. Concomitant administration of a single 1200 mg dose of azithromycin did not alter the pharmacokinetics of a single 800 mg dose of fluconazole. Overall exposure and elimination half-life of azithromycin were unchanged with concomitant fluconazole administration, but a clinically insignificant reduction in Cmax (18%) of azithromycin was observed.

Indinavir. Concomitant administration of a single 1200 mg dose of azithromycin did not cause a statistically significant effect on the pharmacokinetics of indinavir administered at 800 mg three times daily for 5 days.

Methylprednisolone. In a pharmacokinetic interaction study in healthy volunteers, azithromycin did not significantly affect the pharmacokinetics of methylprednisolone.

Midazolam. In healthy volunteers, concomitant administration of azithromycin 500 mg daily for 3 days did not cause clinically significant changes in the pharmacokinetics or pharmacodynamics of midazolam.

Nelfinavir. Concomitant administration of azithromycin (1200 mg) and nelfinavir at steady-state concentrations (750 mg three times daily) leads to increased azithromycin concentrations. No clinically significant adverse events were observed; therefore, dose adjustment is not necessary.

Rifabutin. Concomitant administration of azithromycin and rifabutin did not affect serum concentrations of either drug. Neutropenia was observed in subjects receiving both azithromycin and rifabutin. Although neutropenia was associated with rifabutin use, a causal relationship with concomitant azithromycin administration has not been established.

Sildenafil. In healthy male volunteers, no evidence was found that azithromycin (500 mg daily for 3 days) affected the AUC or Cmax values of sildenafil or its main circulating metabolite.

Terfenadine. There have been no reports of interaction between azithromycin and terfenadine. In some cases, the possibility of such an interaction cannot be entirely excluded; however, there are no specific data confirming such an interaction.

Theophylline. There are no data on clinically significant pharmacokinetic interaction between azithromycin and theophylline.

Triazolam. Concomitant administration of azithromycin 500 mg on the first day and 250 mg on the second day with 0.125 mg triazolam did not significantly affect any pharmacokinetic parameters of triazolam compared to triazolam and placebo.

Trimethoprim/sulfamethoxazole. Concomitant administration of trimethoprim/sulfamethoxazole (160 mg/800 mg) for 7 days with 1200 mg azithromycin on day 7 did not result in a significant effect on peak concentrations, overall exposure, or urinary excretion of trimethoprim or sulfamethoxazole. Serum concentrations of azithromycin were similar to those observed in other studies.

Special precautions for use.

Allergic reactions. As with the use of erythromycin and other macrolide antibiotics, isolated cases of serious allergic reactions have been reported, including angioedema and anaphylaxis (in rare cases fatal), and dermatological reactions, including acute generalized exanthematous pustulosis. Some of these reactions caused by azithromycin have led to recurrence of symptoms and required prolonged observation and treatment.

Hepatic function impairment. Since the liver is the main route of elimination of azithromycin, azithromycin should be administered with caution in patients with severe hepatic impairment. Cases of fulminant hepatitis leading to life-threatening liver failure have been reported during azithromycin therapy. In some patients, underlying liver disease or concomitant use of other hepatotoxic drugs may have contributed. Liver function tests should be performed if signs or symptoms of hepatic dysfunction develop, such as rapidly progressing fatigue associated with jaundice, dark urine, bleeding tendency, or hepatic encephalopathy. If hepatic dysfunction is confirmed, azithromycin should be discontinued.

Ergot derivatives. In patients receiving ergot derivatives, concomitant use of certain macrolide antibiotics may lead to rapid development of ergotism. Data on possible interaction between ergot derivatives and azithromycin are lacking. However, due to the theoretical risk of ergotism, azithromycin should not be administered concomitantly with ergot derivatives.

Superinfections. As with other antibiotics, monitoring for signs of superinfection caused by resistant organisms, including fungi, is recommended.

Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including azithromycin, with severity ranging from mild diarrhea to fatal colitis. Antibacterial therapy alters the normal flora of the colon, leading to overgrowth of C. difficile.

C. difficile produces toxins A and B, which contribute to the development of CDAD. Hyperproducing toxin strains of C. difficile are associated with increased morbidity and mortality, as these infections may be resistant to antimicrobial therapy and may require colectomy. CDAD should be considered in all patients with diarrhea following antibiotic use. Careful medical history is essential, as CDAD has been reported to occur up to two months after antibiotic administration.

Renal function impairment. In patients with severe renal dysfunction (glomerular filtration rate < 10 mL/min), a 33% increase in systemic exposure to azithromycin has been observed.

Prolongation of cardiac repolarization and QT interval, which increases the risk of cardiac arrhythmias and ventricular tachycardia (torsade de pointes), has been observed with other macrolide antibiotics. A similar effect of azithromycin cannot be completely ruled out in patients at increased risk of prolonged cardiac repolarization; therefore, caution is advised when prescribing azithromycin to patients:

• with congenital or documented QT interval prolongation;
• currently receiving treatment with other drugs known to prolong the QT interval, such as class IA (quinidine, procainamide) and class III (dofetilide, amiodarone, sotalol) antiarrhythmics, cisapride, terfenadine, neuroleptics such as pimozide, antidepressants (such as citalopram), and fluoroquinolones, including moxifloxacin and levofloxacin;
• with electrolyte imbalances, particularly hypokalemia and hypomagnesemia;
• with clinically significant bradycardia, cardiac arrhythmias, or severe heart failure.

Myasthenia gravis. Exacerbation of symptoms of myasthenia gravis or new onset of myasthenic syndrome has been reported in patients receiving azithromycin therapy.

Streptococcal infections. Azithromycin is generally effective in the treatment of oropharyngeal streptococcal infections; however, there are no data demonstrating the efficacy of azithromycin in preventing rheumatic fever. An antimicrobial agent with anaerobic activity should be used in combination with azithromycin if anaerobic microorganisms are suspected to contribute to the infection.

The safety of intravenous azithromycin has been evaluated only within the time frames described in clinical trials involving patients with community-acquired pneumonia and pelvic inflammatory disease.

The drug must be reconstituted and diluted according to the instructions and administered as an intravenous infusion over at least 60 minutes. The drug must not be administered as an intravenous bolus or by intramuscular injection.

One vial contains approximately 170 mg of sodium. This should be taken into account when prescribing the drug to patients on a sodium-controlled diet.

Use during pregnancy or breastfeeding.

Due to insufficient data on the safety of azithromycin use, the drug is not recommended during pregnancy or breastfeeding, except when the expected benefit to the mother outweighs the potential risk to the fetus or infant, and in the absence of adequate alternative treatments.

Ability to affect reaction speed when driving or operating machinery.

There is no evidence that azithromycin impairs the ability to drive or operate machinery; however, the possibility of adverse reactions such as dizziness, somnolence, and visual disturbances should be considered.

Method of Administration and Dosage.

Adults.

Community-acquired pneumonia: 500 mg intravenously once daily for at least 2 days, followed by oral therapy with 500 mg of azithromycin once daily as a single daily dose. Total duration of treatment — 7–10 days.

Pelvic inflammatory disease, including infections of the urinary and genital tract, such as endometritis and salpingitis: 500 mg intravenously once daily, followed by oral therapy with 250 mg of azithromycin once daily as a single daily dose. Total duration of treatment — 7 days.

Elderly patients.

Administration of the drug to elderly patients does not require dose adjustment.

Since elderly patients may belong to risk groups for disturbances in cardiac conduction, caution is recommended when using azithromycin due to the risk of developing cardiac arrhythmia and torsade de pointes arrhythmia.

Patients with renal impairment.

For patients with mild renal dysfunction (glomerular filtration rate 10–80 mL/min), the same dosage may be used as for patients with normal renal function. Azithromycin should be administered with caution in patients with severe renal impairment (glomerular filtration rate < 10 mL/min).

Patients with hepatic impairment.

For patients with mild to moderate hepatic dysfunction, the same dosage may be used as for patients with normal liver function.

Method of Administration

The drug should be administered as an intravenous infusion over 3 hours at a concentration of 1 mg/mL or over 1 hour at a concentration of 2 mg/mL. Higher concentrations should be avoided, as infusion site reactions have been observed in volunteers receiving infusions at concentrations exceeding 2 mg/mL.

The infusion duration of azithromycin should be at least 60 minutes.

Azithromycin must not be administered as a bolus injection or intramuscularly.

INSTRUCTIONS FOR PREPARING THE INFUSION SOLUTION

Step 1

Prepare the initial concentrate for infusion solution by adding 4.8 mL of sterile water for injection to the vial containing the lyophilisate. Shake the vial until the powder is completely dissolved. Each mL of the reconstituted concentrate contains 100 mg of azithromycin. The resulting solution should be clear and colorless.

Step 2

Dilute the obtained 5 mL of infusion concentrate with a compatible infusion solution to obtain the final infusion solution containing azithromycin at a concentration of 1 mg/mL or 2 mg/mL (see Table 1 below).

Table 1

Preparation of the final infusion solution

| Final Infusion Concentration | Volume of Infusion Concentrate | Volume of Compatible Diluent | Total Volume of Final Infusion Solution | |------------------------------|----------------------------------|----------------------------------|------------------------------------------| | 1 mg/mL | 5 mL | 475 mL | 480 mL | | 2 mg/mL | 5 mL | 235 mL | 240 mL |

Note: The final infusion solution should be used within 24 hours after preparation when stored at room temperature or within 48 hours if refrigerated (2–8°C).

The concentrate for infusion solution can be diluted with:

• 0.9% sodium chloride,
• 5% glucose,
• Ringer's solution.

Before administration, the reconstituted and diluted solution should be visually inspected for particulate matter. Only clear, particle-free solutions should be used. If the solution contains particles, it must be discarded. Any unused portion of the medication should be disposed of properly.

Children.

The safety and efficacy of intravenous azithromycin for the treatment of infections in children have not been established.

Overdose.

Typical symptoms of overdose: nausea, vomiting, diarrhea, abdominal pain, and reversible hearing loss.

In case of overdose, activated charcoal may be administered if appropriate, along with symptomatic therapy aimed at supporting vital functions.

Adverse Reactions.

When intravenous or oral azithromycin was used for the treatment of community-acquired pneumonia, the most commonly reported adverse events were diarrhea/loose stools, nausea, stomach pain, and vomiting. With intravenous administration of azithromycin, local inflammation/pain at the infusion site was reported. The frequency and severity of these reactions were similar to those observed with infusion of 500 mg azithromycin over 1 hour (2 mg/mL as a 250 mL infusion) or 3 hours (1 mg/mL as a 500 mL infusion).

In adult women receiving intravenous or oral azithromycin for pelvic inflammatory disease, the most commonly reported adverse events were diarrhea, nausea, vaginitis, stomach pain, anorexia, rash, and pruritus. When azithromycin was administered concomitantly with metronidazole, the majority of women experienced adverse events such as nausea, stomach pain, vomiting, infusion site irritation, stomatitis, dizziness, or dyspnea.

Adverse reactions are listed by system organ class, with frequency defined as follows: common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000), very rare (< 1/10,000), and frequency not known (cannot be estimated from available data). Within each organ system class, adverse effects are listed in order of decreasing severity.

Infections and infestations.

Uncommon: candidiasis, oral candidiasis, vaginal infections, pneumonia, fungal infection, bacterial infection, pharyngitis, gastroenteritis, respiratory dysfunction, rhinitis.

Frequency not known: pseudomembranous colitis.

Blood and lymphatic system disorders.

Uncommon: leukopenia, neutropenia, eosinophilia.

Frequency not known: thrombocytopenia, hemolytic anemia.

Immune system disorders.

Uncommon: angioedema, hypersensitivity reactions.

Frequency not known: anaphylactic reaction.

Metabolism and nutrition disorders.

Uncommon: anorexia.

Psychiatric disorders.

Uncommon: nervousness, insomnia.

Rare: agitation.

Frequency not known: aggression, restlessness, delirium, hallucinations.

Nervous system disorders.

Common: headache.

Uncommon: dizziness, somnolence, dysgeusia, paresthesia.

Frequency not known: loss of consciousness, convulsions, hypesthesia, psychomotor hyperactivity, anosmia, parosmia, ageusia, myasthenia gravis.

Eye disorders.

Uncommon: visual disturbances.

Ear and labyrinth disorders.

Uncommon: ear disorders; vertigo.

Frequency not known: hearing impairment, including deafness and/or tinnitus.

Cardiac disorders.

Uncommon: palpitations.

Frequency not known: ventricular fibrillation/torsade de pointes; arrhythmia, including ventricular tachycardia, QT interval prolongation on ECG.

Vascular disorders.

Uncommon: flushing.

Frequency not known: arterial hypotension.

Respiratory, thoracic and mediastinal disorders.

Uncommon: dyspnea, epistaxis.

Gastrointestinal disorders.

Very common: diarrhea.

Common: vomiting, abdominal pain, nausea.

Uncommon: constipation, flatulence, dyspepsia, gastritis, dysphagia, dry mouth, belching, oral ulcers, hypersalivation.

Frequency not known: pancreatitis, change in tongue color.

Hepatobiliary disorders.

Rare: liver function abnormalities, cholestatic jaundice.

Frequency not known: hepatic failure (rarely leading to fatal outcome), fulminant hepatitis, necrotic hepatitis.

Skin and subcutaneous tissue disorders.

Uncommon: rash, pruritus, urticaria, dermatitis, dry skin, hyperhidrosis.

Rare: photosensitivity, acute generalized exanthematous pustulosis.

Frequency not known: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms (DRESS).

Musculoskeletal and connective tissue disorders.

Uncommon: osteoarthritis, myalgia, back pain, neck pain.

Frequency not known: arthralgia.

Renal and urinary disorders.

Uncommon: dysuria, kidney pain.

Frequency not known: acute renal failure, interstitial nephritis.

Reproductive system and breast disorders.

Uncommon: uterine bleeding, testicular disorders.

General disorders and administration site conditions.

Common: injection site pain, injection site inflammation.

Uncommon: swelling, asthenia, malaise, fatigue, facial swelling, chest pain, hyperthermia, pain, peripheral edema.

Investigations.

Common: decreased lymphocyte count, increased eosinophil count, decreased blood bicarbonate level, increased basophil count, increased monocyte count, increased neutrophil count.

Uncommon: increased aspartate aminotransferase, increased alanine aminotransferase, increased blood bilirubin, increased blood urea, increased blood creatinine, blood potassium abnormalities, increased alkaline phosphatase, increased chloride level, increased glucose level, increased platelet count, decreased hematocrit, increased bicarbonate level, sodium level abnormalities.

Injury, poisoning and procedural complications.

Uncommon: procedural complications.

Information on adverse reactions possibly associated with the prophylaxis and treatment of Mycobacterium Avium Complex is based on clinical trial data and post-marketing surveillance. These adverse reactions differ in type or frequency from those reported with immediate-release and extended-release formulations.

Adverse reactions possibly associated with prophylaxis and treatment of Mycobacterium Avium Complex.

Metabolism and nutrition disorders.

Common: anorexia.

Nervous system disorders.

Common: dizziness, headache, paresthesia, dysgeusia.

Uncommon: hypesthesia.

Eye disorders.

Common: visual disturbances.

Ear and labyrinth disorders.

Common: deafness.

Uncommon: hearing impairment, tinnitus.

Cardiac disorders.

Uncommon: palpitations.

Gastrointestinal disorders.

Very common: diarrhea, abdominal pain, nausea, flatulence, gastrointestinal discomfort, frequent loose stools.

Hepatobiliary disorders.

Uncommon: hepatitis.

Skin and subcutaneous tissue disorders.

Common: rash, pruritus.

Uncommon: Stevens-Johnson syndrome, photosensitivity.

Musculoskeletal and connective tissue disorders.

Common: arthralgia.

General disorders and administration site conditions.

Common: increased fatigue.

Uncommon: asthenia, malaise.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Incompatibilities.

Use only the solvents specified in the section "Instructions for Use and Dosage."

Packaging.

500 mg in a vial, 1 vial per cardboard pack.

Prescription status. Prescription only.

Manufacturer.

LLC "FARMEKS GROUP".

Manufacturer's address and location of business activity.

100 Shevchenka Street, Boryspil, Kyiv Oblast, Ukraine, 08301.

All cases of adverse reactions should be reported to the manufacturer:

LLC "Farmeks Group", 100 Shevchenka Street, Boryspil, Kyiv Oblast, Ukraine, 08301, tel. +38(044)391-19-19, fax: +38(044)391-19-18, or via the form on the website: http://www.pharmex.com.ua/kontakty/forma-137-o/

Date of last review.