Azithromycin-cr

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

Composition:

Active ingredient: azithromycin;

5 ml of suspension contain azithromycin (calculated as 100 % substance) 200 mg;

Excipients: sodium carbonate anhydrous, sodium benzoate (E 211), purified sodium carboxymethylcellulose, titanium dioxide (E 171), glycine, colloidal anhydrous silicon dioxide, strawberry flavor, banana flavor, white sugar.

Pharmaceutical form. Granular powder for oral suspension.

Main physicochemical properties: granular powder from white to yellowish-white with a strawberry and banana odor.

Pharmacotherapeutic group. Antibacterial agents for systemic use. Macrolides, lincosamides and streptogramins. Azithromycin.

ATC code J01FA10.

Pharmacological Properties.

Pharmacodynamics.

Azithromycin is a representative of a new group of macrolide antibiotics – azalides. It has a broad spectrum of antimicrobial activity. By binding to the 50S ribosomal subunit, it inhibits microbial protein synthesis.

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

Spectrum of antimicrobial activity of azithromycin.

Azithromycin is active against a number of aerobic gram-positive bacteria: Staphylococcus aureus (methicillin-sensitive), Streptococcus pneumoniae (penicillin-sensitive), Streptococcus pyogenes. It is effective against gram-negative microorganisms: Haemophilus influenzae, H. parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida. It acts against susceptible anaerobic microbes: Clostridium perfringens, Fusobacterium spp., Prevotella spp., Porphyriomonas spp. In addition, it is effective against intracellular and other microorganisms, including Chlamydia trachomatis and Chlamydia pneumoniae, Mycoplasma pneumoniae.

Organisms for which acquired resistance may be a concern.

Anaerobic gram-positive bacteria: Streptococcus pneumoniae with intermediate sensitivity to penicillin and penicillin-resistant strains.

Inherently resistant organisms.

Aerobic gram-positive bacteria: Enterococcus faecalis.

Staphylococci MRSA, MRSE (methicillin-resistant Staphylococcus aureus has a very high prevalence of acquired resistance to macrolides and is listed here due to rare sensitivity to azithromycin).

Anaerobic bacteria: Bacteroides fragilis.

Pharmacokinetics.

After oral administration, azithromycin is well absorbed in the gastrointestinal tract and rapidly distributed throughout the body. High antibiotic concentrations are achieved in tissues. It has a long elimination half-life and is slowly eliminated from tissues. These properties allow the drug to be administered once daily for three days. Azithromycin penetrates well into cells, including phagocytes, which migrate to the site of inflammation, thereby facilitating the delivery of therapeutic drug concentrations to the site of infection. The drug is excreted mainly unchanged in bile, with a small portion eliminated by the kidneys.

Clinical characteristics.

Indications.

Infections caused by microorganisms sensitive to azithromycin:

• Infections of the upper respiratory tract (bacterial pharyngitis/tonsillitis, sinusitis, otitis media);
• Infections of the lower respiratory tract (bacterial bronchitis, community-acquired pneumonia);
• Infections of the skin and soft tissues (erythema migrans (early stage of Lyme disease), erysipelas, impetigo, secondary pyoderma).

Contraindications.

Hypersensitivity to azithromycin, erythromycin, or to any macrolide or ketolide antibiotic, or to any other component of the drug. Due to the theoretical possibility of ergotism, azithromycin should not be administered concomitantly with ergot derivatives.

Interaction with other medicinal products and other forms of interaction.

Azithromycin should be administered with caution to 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 peak plasma concentrations of azithromycin decreased by 25%. Azithromycin and antacids should not be taken simultaneously.

Cetirizine. In healthy volunteers, concomitant administration of azithromycin for 5 days with cetirizine 20 mg at steady state showed no evidence of pharmacokinetic interaction or significant changes in the QT interval.

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.

Cyclosporine. In a pharmacokinetic study involving healthy volunteers who received oral 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 these drugs are used concomitantly. If concomitant use is necessary, cyclosporine levels should be monitored and the dose adjusted accordingly.

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

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 substrate. Therefore, when azithromycin is used concomitantly with digoxin, the possibility of increased digoxin concentrations should be considered, and serum levels of the drug should be monitored.

Methylprednisolone. In a pharmacokinetic interaction study in healthy volunteers, azithromycin did not show a significant effect on the pharmacokinetics of methylprednisolone.

Terfenadine. Pharmacokinetic studies have not reported any interaction between azithromycin and terfenadine. In some cases, the possibility of such an interaction cannot be completely excluded, but there are no specific data confirming such an interaction.

Theophylline. Azithromycin did not affect the pharmacokinetics of theophylline when co-administered with theophylline in healthy volunteers. However, combined use of theophylline with other macrolide antibiotics has occasionally led to increased serum levels of theophylline.

Zidovudine. Single doses of 1000 mg and multiple doses of 1200 mg or 600 mg of azithromycin had minimal effect on the plasma pharmacokinetics or urinary excretion of zidovudine or its glucuronide metabolites. However, administration of azithromycin increased the concentration of phosphorylated zidovudine, the clinically active metabolite, in peripheral blood mononuclear cells. The clinical significance of these data is unclear, but it may be beneficial for patients.

Macrolide antibiotics may potentiate the effects of theophylline, terfenadine, warfarin, carbamazepine, phenytoin, triazolam, digoxin, ergotamine, and cyclosporine. Azithromycin has no significant interaction with the hepatic cytochrome P450 system. It is considered that the drug does not have the pharmacokinetic drug interactions typical of erythromycin and other macrolides. Azithromycin does not cause induction or inactivation of hepatic cytochrome P450 via the cytochrome-metabolite complex.

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

Pharmacokinetic studies have been conducted on the use of azithromycin with the following drugs, whose metabolism is largely mediated by cytochrome P450.

Didanosine. In six HIV-positive volunteers, concomitant administration of daily doses of 1200 mg azithromycin with 400 mg didanosine per day showed no effect on the steady-state pharmacokinetics of didanosine compared to placebo.

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

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

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

Efavirenz. Concomitant administration of a single 600 mg dose of azithromycin and 400 mg of 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. Total exposure and elimination half-life of azithromycin were not altered by 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.

Midazolam. In healthy volunteers, concomitant administration of azithromycin 500 mg daily for 3 days did not cause clinically significant changes in the pharmacokinetics and pharmacodynamics of midazolam administered as a single 15 mg dose.

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

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

Terfenadine. Pharmacokinetic studies have not reported any interaction between azithromycin and terfenadine. In some cases, the possibility of such an interaction cannot be completely excluded, but there are no specific data confirming such an interaction.

Triazolam. Concomitant administration to healthy volunteers 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 with placebo.

Trimethoprim/sulfamethoxazole. Concomitant administration of double-strength trimethoprim/sulfamethoxazole (160 mg/800 mg) for 7 days with 1200 mg azithromycin on the seventh day showed no significant effect on peak concentrations, total exposure, or urinary excretion of either trimethoprim or sulfamethoxazole. Azithromycin serum concentrations were consistent with those observed in other studies.

Special precautions for use.

Shake the suspension well before use.

This dosage form is not intended for the treatment of children with body weight less than 15 kg.

As with erythromycin and other macrolide antibiotics, rare but serious allergic reactions have been reported, including angioneurotic edema and anaphylaxis (in rare cases fatal), DRESS syndrome, and dermatological reactions, including acute generalized exanthematous pustulosis. Some of these reactions led to recurrent symptoms and required prolonged observation and treatment.

Since the liver is the primary route of elimination for azithromycin, caution should be exercised when prescribing azithromycin to patients with severe hepatic impairment. Cases of fulminant hepatitis leading to life-threatening liver failure have been reported with azithromycin use. Some patients may have had pre-existing liver disease or concomitant use of other hepatotoxic medicinal products.

Liver function tests should be performed if signs or symptoms of hepatic dysfunction develop, such as rapidly progressing asthenia accompanied by jaundice, dark urine, tendency to bleeding, or hepatic encephalopathy.

If hepatic dysfunction occurs, azithromycin should be discontinued.

In patients receiving ergot derivatives, concomitant administration of certain macrolide antibiotics has been associated with rapid onset of ergotism. Data on the potential interaction between ergot derivatives and azithromycin are lacking. However, due to the theoretical risk of ergotism, azithromycin should not be co-administered with ergot derivatives.

Prolongation of cardiac repolarization and QT interval, increasing the risk of cardiac arrhythmias and ventricular tachycardia (torsade de pointes), has been observed with other macrolide antibiotics, including azithromycin. Since conditions associated with increased risk of ventricular arrhythmias (including torsade de pointes) may lead to cardiac arrest, azithromycin should be used with caution in patients with existing proarrhythmic conditions (particularly women and elderly patients), especially in patients:

with congenital or documented acquired prolongation of the QT interval;

currently receiving treatment with other medicinal products known to prolong the QT interval, such as class IA (quinidine, procainamide) and class III antiarrhythmics (dofetilide, amiodarone, sotalol), cisapride, terfenadine, neuroleptics such as pimozide, antidepressants such as citalopram, and fluoroquinolones such as moxifloxacin and levofloxacin;

with electrolyte imbalances, particularly hypokalemia and hypomagnesemia;

with clinically significant bradycardia, cardiac arrhythmias, or severe heart failure.

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

Pharyngitis/Tonsillitis. Azithromycin is not the drug of first choice for the treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes. For this indication and for prevention of acute rheumatic fever, penicillin is the drug of first choice.

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

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

C. difficile produces toxins A and B, which contribute to the development of CDAD. Strains of C. difficile that hyperproduce toxins are associated with increased morbidity and mortality, as these infections may be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who develop diarrhea following antibiotic use. A careful medical history is necessary, as CDAD has been reported to occur as late as two months after administration of antibacterial agents.

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

Safety and efficacy for the prevention or treatment of Mycobacterium avium complex (MAC) in children have not been established.

Since the product contains sucrose (table sugar), it should not be administered to patients with rare hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.

In case of an allergic reaction, the drug should be discontinued and appropriate therapy initiated. Physicians should be aware that allergic symptoms may recur after discontinuation of symptomatic treatment.

Use during pregnancy or breastfeeding.

Pregnancy.

There are no adequate data on azithromycin use in pregnant women. In reproductive toxicity studies in animals, azithromycin did not show teratogenic effects on the fetus, but the drug was shown to cross the placenta. The safety of azithromycin use during pregnancy has not been established. Therefore, azithromycin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breastfeeding period.

Azithromycin has been reported to be excreted into human breast milk. However, adequate and well-controlled clinical studies characterizing the pharmacokinetics of azithromycin excretion into human breast milk have not been conducted.

Fertility.

Fertility studies have been conducted in rats; a decrease in pregnancy rate was observed after administration of azithromycin. The relevance of these findings to humans is unknown.

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.

Azithromycin should be taken once daily, at least 1 hour before or 2 hours after a meal.

If a dose is missed, it should be taken as soon as possible. Subsequent doses should be taken at 24-hour intervals.

Dose measurement

Your package includes a dosing syringe and a measuring spoon.

Your doctor will advise you whether to use the spoon or syringe.

A measuring spoon filled to the brim contains 5 ml; filled to the mark, it contains 2.5 ml.

For infections of the upper and lower respiratory tract and skin and soft tissue infections (excluding erythema migrans), the recommended dose is 10 mg/kg body weight once daily for 3 days.

Depending on the child's body weight, the following doses are recommended for the 200 mg/5 ml suspension formulation:

Body weight, kg	Daily dose suspension	Dosing frequency	Amount of azithromycin in the daily dose of suspension
15 - 24	5 ml	1 time/day	200 mg
25 - 34	7.5 ml		300 mg
35 - 44	10 ml		400 mg
over 45	12.5 ml		500 mg

SUSPENSION PREPARATION

The measuring syringe can be used to measure the amount of water required for dissolving the medication.

1. The vial contains a powder, which is mixed with water (distilled or boiled and cooled) to prepare a suspension.

Suspension with concentration of 200 mg/5 mL: To prepare 30 mL of Azithromycin-KR suspension, add 18 mL of water. Measure the appropriate amount of water using a clean container and add it to the vial containing the medication.

1. Shake the vial thoroughly until a homogeneous suspension is obtained.
2. Shelf life of the prepared suspension is 5 days.

FILLING THE SYRINGE WITH MEDICATION

1. Shake the suspension well before administration.
2. Immerse the syringe into the suspension and, by pulling the plunger upwards, draw in the required amount of suspension.

1. If you notice air bubbles in the syringe, return the medication to the vial and repeat step 3.

ADMINISTRATION OF MEDICATION TO A CHILD

1. Position the child as for feeding.
2. Place the tip of the syringe into the child's mouth and slowly expel the contents.
3. Allow the child time to gradually swallow the entire dose.

1. After administration, give the child a small amount of tea or juice to wash down and swallow any remaining suspension in the oral cavity.

CLEANING AND STORAGE

1. Wash the used syringe with running water, dry it, and store in a clean, dry place together with the medication.

1. After the child has taken the last dose of medication, the syringe and vial should be disposed of properly.

For erythema migrans: administer once daily for 5 days: on day 1, the dose is 20 mg/kg; from day 2 to day 5, 10 mg/kg daily.

Azithromycin has been shown to be effective in the treatment of streptococcal pharyngitis in children as a single daily dose of 10 mg/kg or 20 mg/kg for 3 days. Clinical studies comparing these two doses have demonstrated similar clinical efficacy, although bacterial eradication was greater with the 20 mg/kg daily dose. However, penicillin remains the drug of choice for the prevention of pharyngitis caused by Streptococcus pyogenes and for the prevention of rheumatic polyarthritis as a secondary complication.

Patients with renal impairment

The same dosage regimen may be used in patients with mild renal impairment (glomerular filtration rate 10–80 mL/min) as in 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

Since azithromycin is metabolized in the liver and excreted via bile, it should not be administered to patients with severe hepatic disease. Clinical studies on the use of azithromycin in such patients have not been conducted.

Children

Not recommended for children weighing less than 15 kg.

Overdose

Clinical experience with azithromycin indicates that adverse reactions associated with doses higher than recommended are similar to those observed with standard therapeutic doses. These may include diarrhea, nausea, vomiting, and reversible hearing loss. In case of overdose, administration of activated charcoal and implementation of general symptomatic and supportive measures are recommended as needed.

Adverse Reactions

Azithromycin is well tolerated and has a low incidence of adverse effects.

The adverse reactions listed below were identified through clinical trials and post-marketing surveillance for all dosage forms of azithromycin, classified by system organ class and frequency of occurrence. Reactions reported during post-marketing surveillance are indicated in italics. Frequency groups were defined using the following scale: very common (> 1/10); common (> 1/100, < 1/10); uncommon (> 1/1000, < 1/100); rare (> 1/10,000, < 1/1000); very rare (< 1/10,000); frequency not known (cannot be estimated from available data). Within each frequency group, adverse events are listed in order of decreasing severity.

Adverse reactions possibly or probably related to azithromycin based on data from clinical trials and post-marketing surveillance.

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.

Isolated reports of transient, mild neutropenia were observed in clinical trials; however, a causal relationship with azithromycin treatment has not been established.

Immune system disorders: uncommon – angioneurotic edema, 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 – syncope, convulsions, hypesthesia, psychomotor hyperactivity, anosmia, ageusia, parosmia, myasthenia gravis.

Eye disorders: uncommon – visual disturbances.

Ear and labyrinth disorders: uncommon – ear disorders, vertigo; frequency not known – hearing disturbances, including deafness and/or tinnitus.

Most of these cases were associated with experimental studies in which azithromycin was administered in high doses over prolonged periods. According to available follow-up reports, most of these events were reversible.

Cardiac disorders: uncommon – palpitations; frequency not known – ventricular fibrillation/torsades de pointes, arrhythmia including ventricular tachycardia, QT interval prolongation on ECG.

Vascular disorders: uncommon – flushing; frequency not known – 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, tongue discoloration.

Hepatobiliary disorders: rare – liver function abnormalities, cholestatic jaundice; frequency not known – hepatic failure (rarely leading to fatal outcome), fulminant hepatitis, necrotizing hepatitis.

Mild, reversible increases in liver enzyme activity may occur. Abnormal test results typically normalize within 2–3 weeks after discontinuation of therapy.

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, renal 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: uncommon – edema, 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, alanine aminotransferase, blood bilirubin, blood urea, serum creatinine; changes in blood potassium levels, increased alkaline phosphatase, chloride, glucose, platelet count; decreased hematocrit; increased bicarbonate level, deviation from normal sodium levels.

Injury, poisoning and procedural complications: uncommon – procedural complications.

Information on adverse reactions possibly associated with prophylaxis and treatment of Mycobacterium avium complex is based on data from clinical trials and post-marketing observations. 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.

Eye disorders: common – visual disturbances.

Ear and labyrinth disorders: uncommon – hearing disturbances, 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

The shelf life of granulated powder for oral suspension is 2 years.

The shelf life of the reconstituted suspension is 5 days.

Storage Conditions

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

Keep out of reach of children.

Packaging

25.4 g in glass bottles closed with plastic caps with tamper-evident seal.

Each bottle, together with the package leaflet, calibrated dosing syringe, and measuring spoon, is placed in a carton.

Prescription Category

Prescription only.

Manufacturer

JSC "CHEMICAL PHARMACEUTICAL PLANT "CHERVONA ZIRKA".

Manufacturer's Address and Place of Business

Ukraine, 61010, Kharkiv region, Kharkiv city, Gordienkivska Street, 1.