Instructions Sumamed powder for oral suspension with strawberry flavor 100mg/5ml 20 ml
Composition
active ingredient: azithromycin;
1 dose (5 ml) of suspension contains 100 mg of azithromycin as azithromycin dihydrate;
excipients: sucrose, sodium phosphate, hydroxypropylcellulose, xanthan gum, colloidal anhydrous silicon dioxide,
flavoring(s) and/or coloring:
banana flavoring, cherry flavoring, vanilla flavoring
or
titanium dioxide (E 171), strawberry flavoring.
Dosage form
Powder for oral suspension.
Main physicochemical properties: white or yellowish-white powder with a characteristic smell of cherry and banana or strawberry.
The reconstituted suspension is a homogeneous yellowish-white suspension with a characteristic odor of cherry and banana or strawberry.
Pharmacotherapeutic group
Antibacterials for systemic use. Macrolides, lincosamides and streptogramins. Azithromycin. ATC code J01F A10.
Pharmacological properties
Pharmacodynamics.
Azithromycin is a macrolide antibiotic belonging to the azalide group. The molecule is formed by the introduction of a nitrogen atom into the lactone ring of erythromycin A. The mechanism of action of azithromycin is to inhibit bacterial protein synthesis by binding to the 50S subunit of ribosomes and inhibiting peptide translocation.
Mechanism of resistance.
Complete cross-resistance exists among Streptococcus pneumoniae, group A beta-hemolytic streptococcus, Enterococcus faecalis, and Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus (MRSA), to erythromycin, azithromycin, other macrolides, and lincosamides.
The prevalence of acquired resistance for selected species may vary with location and time, therefore local information on resistance is required, particularly when treating severe infections. Qualified advice may be sought if the local prevalence of resistance is such that the efficacy of the drug in treating at least some types of infections is questionable.
Spectrum of antimicrobial activity of azithromycin
| Typically sensitive species |
| Aerobic Gram-positive bacteria |
| Staphylococcus aureus methicillin-susceptible |
| Streptococcus pneumoniae penicillin-susceptible |
| Streptococcus pyogenes |
| Aerobic Gram-negative bacteria |
Haemophilus influenzae Haemophilus parainfluenzae |
| Legionella pneumophila |
| Moraxella catarrhalis |
| Pasteurella multocida |
| Anaerobic bacteria |
| Clostridium perfringens |
| Fusobacterium spp. |
| Prevotella spp. |
| Porphyriomonas spp. |
| Other microorganisms |
Chlamydia trachomatis Chlamydia pneumoniae Mycoplasma pneumoniae |
| Species for which acquired resistance may be a problem |
| Aerobic Gram-positive bacteria |
| Streptococcus pneumoniae with intermediate susceptibility to penicillin and penicillin-resistant |
| Inherently resistant organisms |
| Aerobic Gram-positive bacteria |
| Enterococcus faecalis |
| Staphylococci MRSA, MRSE* |
| Anaerobic bacteria |
| Bacteroides fragilis group |
*Methicillin-resistant Staphylococcus aureus has a very high prevalence of acquired resistance to macrolides and has been listed here because of its rare susceptibility to azithromycin.
Pharmacokinetics.
Bioavailability after oral administration is approximately 37%. Maximum serum concentrations are reached 2–3 hours after administration.
When taken orally, azithromycin is distributed throughout the body. Pharmacokinetic studies have shown that the concentration of azithromycin in tissues is significantly higher (50 times) than in blood plasma, which indicates strong binding of the drug to tissues.
Serum protein binding varies with plasma concentrations and ranges from 12% at 0.5 μg/mL to 52% at 0.05 μg/mL in serum. The apparent volume of distribution at steady state (VVss) was 31.1 L/kg.
The terminal plasma half-life fully reflects the tissue half-life of 2–4 days.
Approximately 12% of an intravenous dose of azithromycin is excreted unchanged in the urine over the next 3 days. Particularly high concentrations of unchanged azithromycin have been found in human bile. Also found in bile are 10 metabolites formed by N- and O-demethylation, hydroxylation of the desosamine and aglycone rings, and cleavage of the cladinose conjugate. Comparison of the results of liquid chromatography and microbiological analyses showed that the metabolites of azithromycin are not microbiologically active.
Indication
Infections caused by microorganisms sensitive to azithromycin:
ENT infections (bacterial pharyngitis/tonsillitis, sinusitis, otitis media);
respiratory tract infections (bacterial bronchitis, community-acquired pneumonia);
Skin and soft tissue infections: erythema migrans (initial stage of Lyme disease), erysipelas, impetigo, secondary pyodermatoses.
Contraindication
Hypersensitivity to azithromycin, erythromycin or any macrolide or ketolide antibiotic, or to any other component of the drug.
Interaction with other medicinal products and other types of interactions
Antacids: When studying the effect of concomitant administration of antacids on the pharmacokinetics of azithromycin, there was generally no change in bioavailability, although the peak plasma concentration of azithromycin was reduced by approximately 25%. Azithromycin and antacids should not be taken simultaneously.
Cetirizine: In healthy volunteers, coadministration of azithromycin for 5 days with cetirizine 20 mg at steady state did not result in any pharmacokinetic interaction or significant changes in the QT interval.
Didanosine: Coadministration of daily doses of 1200 mg azithromycin with 400 mg didanosine per day in six HIV-positive volunteers had no effect on the steady-state pharmacokinetics of didanosine compared to placebo.
Digoxin and Colchicine: Concomitant use of macrolide antibiotics, including azithromycin, and P-glycoprotein substrates such as digoxin and colchicine has been reported to increase serum levels of the P-glycoprotein substrate. Therefore, the possibility of increased serum substrate concentrations should be considered when azithromycin is coadministered with a P-glycoprotein substrate such as digoxin.
Zidovudine. Single doses of 1000 mg and multiple doses of 1200 mg or 600 mg of azithromycin had little effect on the plasma pharmacokinetics or urinary excretion of zidovudine or its glucuronide metabolites. However, azithromycin increased the concentrations of phosphorylated zidovudine, the clinically active metabolite, in peripheral blood mononuclear cells. The clinical significance of these findings is unclear but may be useful for patients.
Azithromycin does not have a significant interaction with the hepatic cytochrome P450 system. It is believed that the drug does not have the pharmacokinetic drug interactions characteristic of erythromycin and other macrolides. Azithromycin does not induce or inactivate hepatic cytochrome P450 through the cytochrome-metabolite complex.
Ergot: Due to the theoretical possibility of ergotism, the simultaneous administration of azithromycin with ergot derivatives is not recommended.
Pharmacokinetic studies have been conducted on the use of azithromycin and the following drugs, the metabolism of which occurs to a large extent with the participation of cytochrome P450.
Atorvastatin: Coadministration of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not alter plasma concentrations of atorvastatin (based on HMG CoA reductase inhibition assay). However, postmarketing cases of rhabdomyolysis have been reported in patients receiving azithromycin with statins.
Carbamazepine: In a pharmacokinetic interaction study in healthy volunteers, azithromycin had no significant effect on the plasma levels of carbamazepine or its active metabolites.
Cimetidine: In a pharmacokinetic study of the effect of a single dose of cimetidine taken 2 hours before azithromycin on the pharmacokinetics of azithromycin, no changes in the pharmacokinetics of azithromycin were observed.
Oral Coumarin Anticoagulants. In a pharmacokinetic interaction study, azithromycin did not alter the anticoagulant effect of a single 15 mg dose of warfarin administered to healthy volunteers. Postmarketing reports of potentiation of the anticoagulant effect following concomitant administration of azithromycin and oral coumarin anticoagulants have been received. Although a causal relationship has not been established, frequent monitoring of prothrombin time should be considered when prescribing azithromycin to patients receiving oral coumarin anticoagulants.
Cyclosporine: A pharmacokinetic study in healthy volunteers receiving oral azithromycin 500 mg/day for 3 days followed by a single oral dose of cyclosporine 10 mg/kg demonstrated a significant increase in Cmax and AUC0-5 of cyclosporine. Therefore, caution should be exercised when these drugs are used concomitantly. If concomitant use of these drugs is necessary, cyclosporine levels should be monitored and the dose adjusted accordingly.
Efavirenz: Co-administration of a single dose of azithromycin 600 mg and efavirenz 400 mg daily for 7 days did not result in any clinically significant pharmacokinetic interaction.
Fluconazole: Coadministration of a single dose of 1200 mg azithromycin did not alter the pharmacokinetics of a single dose of 800 mg fluconazole. The total exposure and half-life of azithromycin were not altered by coadministration of fluconazole, but a clinically insignificant decrease in Cmax (18%) of azithromycin was observed.
Indinavir: Coadministration of a single dose of azithromycin 1200 mg did not have a statistically significant effect on the pharmacokinetics of indinavir administered at a dose of 800 mg 3 times daily for 5 days.
Methylprednisolone: In a pharmacokinetic interaction study in healthy volunteers, azithromycin did not significantly affect the pharmacokinetics of methylprednisolone.
Nelfinavir. Co-administration of azithromycin (1200 mg) and nelfinavir at steady-state concentrations (750 mg 3 times a day) resulted in increased azithromycin concentrations. No clinically significant adverse events were observed, and no dose adjustment is required.
Rifabutin. Concomitant administration of azithromycin and rifabutin did not affect the serum concentrations of these drugs. Neutropenia has been observed in subjects receiving azithromycin and rifabutin concomitantly. Although neutropenia has been associated with rifabutin, a causal relationship to concomitant azithromycin has not been established.
Sildenafil: In healthy male volunteers, there was no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC and Cmax of sildenafil or its major circulating metabolite.
Terfenadine: No pharmacokinetic interaction has been reported between azithromycin and terfenadine. In some cases, the possibility of such an interaction cannot be completely excluded; however, there is no specific data on the existence of such an interaction.
Theophylline: There is no evidence of a clinically significant pharmacokinetic interaction when azithromycin and theophylline are coadministered in healthy volunteers.
Triazolam: Coadministration of azithromycin 500 mg on the first day and 250 mg on the second day with 0.125 mg of triazolam in healthy volunteers had no significant effect on all pharmacokinetic parameters of triazolam compared to triazolam and placebo.
Trimethoprim/sulfamethoxazole: Coadministration of trimethoprim/sulfamethoxazole at a double strength (160 mg/800 mg) for 7 days with azithromycin 1200 mg on day 7 had no significant effect on the maximum concentrations, total exposure, or urinary excretion of trimethoprim or sulfamethoxazole. Serum azithromycin concentrations were consistent with those observed in other studies.
Hydroxychloroquine: Azithromycin should be used with caution in patients receiving drugs that prolong the QT interval and may cause cardiac arrhythmias, such as hydroxychloroquine.
Application features
As with erythromycin and other macrolide antibiotics, isolated reports of serious allergic reactions, including angioedema and anaphylaxis (in isolated cases fatal), and dermatological reactions, including acute generalized exanthematous pustulosis, have been reported. Some of these reactions caused by azithromycin have resulted in recurrent symptoms and have required longer observation and treatment.
Since the liver is the primary route of elimination of azithromycin, caution should be exercised when prescribing azithromycin to patients with severe liver disease. Cases of fulminant hepatitis, resulting in life-threatening liver failure, have been reported with azithromycin. Some patients may have had a history of liver disease or were taking other hepatotoxic drugs.
Liver function tests should be performed if signs and symptoms of liver dysfunction develop, such as rapidly progressive asthenia accompanied by jaundice, dark urine, bleeding tendency, or hepatic encephalopathy. Azithromycin should be discontinued if liver function abnormalities are detected.
In patients taking ergot derivatives, the simultaneous use of some macrolide antibiotics contributes to the rapid development of ergotism. There is no data on the possibility of interaction between ergot and azithromycin. However, due to the theoretical possibility of ergotism, azithromycin should not be prescribed simultaneously with ergot derivatives.
As with other antibiotics, observation for signs of superinfection due to non-susceptible organisms, including fungi, is recommended.
Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including azithromycin, and has ranged in severity 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. C. difficile strains that overproduce toxins are associated with increased morbidity and mortality, as these infections may be resistant to antimicrobial therapy and require colectomy. The possibility of CDAD should be considered in all patients with antibiotic-associated diarrhea. Careful medical history is required, as CDAD has been reported to occur within 2 months of antibiotic therapy.
In patients with severe renal dysfunction (glomerular filtration rate < 10 mL/min), a 33% increase in systemic exposure to azithromycin was observed.
with congenital or registered prolongation of the QT interval;
who are currently being treated with other active substances known to prolong the QT interval, such as antiarrhythmics of classes IA (quinidine and procainamide) and III (dofetilide, amiodarone and sotalol), cisapride and terfenadine, neuroleptics such as pimozide; antidepressants such as citalopram, and fluoroquinolones such as moxifloxacin and levofloxacin;
with electrolyte imbalance, especially in the case of hypokalemia and hypomagnesemia;
with clinically relevant bradycardia, cardiac arrhythmia or severe heart failure.
Exacerbation of symptoms of myasthenia gravis or new development of myasthenic syndrome have been reported in patients receiving azithromycin therapy.
Streptococcal infections. Penicillin is usually the drug of choice for the treatment of pharyngitis/tonsillitis caused by Streptococcus pyogenes, and is also used for prophylaxis in acute rheumatic fever. Azithromycin is generally effective in the treatment of streptococcal oropharyngeal infections; however, there are no data demonstrating the efficacy of azithromycin in the prevention of rheumatic fever.
The safety and effectiveness of intravenous azithromycin for the treatment of infections in children have not been established.
Safety and effectiveness for the prevention or treatment of Mycobacterium Avium Complex in children have not been established.
Sumamed® powder for oral suspension contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Azithromycin powder for oral suspension contains 83.7 mg/dose of sodium phosphate. Caution should be exercised when administering to patients on a controlled sodium diet.
Use during pregnancy or breastfeeding
Pregnancy.
There are no adequate data on the use of azithromycin in pregnant women. In animal reproductive toxicity studies, azithromycin did not show teratogenic effects on the fetus, but the drug crossed the placenta. The safety of azithromycin during pregnancy has not been established. Therefore, azithromycin should be used during pregnancy only if the benefit outweighs the risk.
breast-feeding.
Azithromycin has been reported to pass into human breast milk, but adequate and well-controlled clinical studies to characterize the pharmacokinetics of azithromycin excretion into human breast milk have not been conducted.
Fertility.
Fertility studies have been conducted in rats; pregnancy rates were reduced following administration of azithromycin. The relevance of these findings to humans is unknown.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no evidence that azithromycin can impair the ability to drive or operate other mechanisms, but the possibility of developing adverse reactions such as delirium, hallucinations, dizziness, drowsiness, fainting, and seizures, which may affect the ability to drive or operate other mechanisms, should be taken into account.
Method of administration and doses
Sumamed®, powder for oral suspension, is used once a day at least 1 hour before or 2 hours after a meal.
If you miss a dose of the drug, take the missed dose as soon as possible, and the following doses should be taken at 24-hour intervals.
Dose measurement
The package contains a graduated syringe for oral dosing. The syringe volume is 5 ml.
For infections of the ENT organs and respiratory tract, skin and soft tissues (except chronic migratory erythema), the daily dose of azithromycin is 10 mg/kg body weight, which corresponds to 0.5 ml/kg body weight of the prepared suspension. The duration of treatment is 3 days.
Depending on the child's body weight, the following dosage regimen for Sumamed® suspension is recommended:
| Body weight (kg) | Daily dose of suspension (ml) | Frequency of reception | Azithromycin content in the daily dose of suspension |
5 | 2.5 | 1 time/day | 50 mg |
6 | 3 | 60 mg |
7 | 3.5 | 70 mg |
8 | 4 | 80 mg |
9 | 4.5 | 90 mg |
10–14 | 5 | 100 mg |
To obtain a ready-made suspension, add to the vial with the powder: 12 ml of water |
Preparation and use of suspension
Distilled or boiled and cooled water must be added to the bottle containing the powder.
1. Press the bottle cap down and turn it counterclockwise.
2. From a clean container, use a dosing syringe to measure 12 ml of water and add it to the vial with the powder.
4. Dip the syringe into the suspension and, pulling the piston upwards, draw the required amount of suspension.
5. If there are air bubbles in the syringe, return the drug to the vial and repeat procedure 3.
6. Position the baby as for feeding.
7. Place the tip of the syringe in the child's mouth and slowly squeeze out the contents.
8. Give the child the opportunity to gradually swallow the entire amount.
9. After taking the drug, let the child drink some tea or juice to wash away and swallow any remaining suspension in the oral cavity.
10. Disassemble the used syringe, rinse with running water, dry and store in a dry and clean place together with the drug.
11. After the child has taken the last dose of the drug, the syringe and vial should be disposed of.
In case of erythema migrans, the duration of treatment is 5 days. On the 1st day, 20 mg/kg of body weight of azithromycin should be taken, which corresponds to 1 ml/kg of the prepared suspension. From the 2nd to the 5th day, 10 mg/kg of body weight should be taken, which corresponds to 0.5 ml/kg of the prepared suspension.
The total course dose is 60 mg/kg.
| Days of treatment | 1 | 2 | 3 | 4 | 5 |
| Daily dose (ml/kg) | 1 | 0.5 | 0.5 | 0.5 | 0.5 |
To obtain a ready-made suspension in a vial with powder 12 ml of water should be added |
Azithromycin has been shown to be effective in the treatment of streptococcal pharyngitis in children given as a single dose of 10 mg/kg or 20 mg/kg for 3 days. When these 2 doses were compared in clinical trials, similar clinical efficacy was found, although bacterial eradication was greater with the daily dose of 20 mg/kg. However, penicillin is usually the drug of choice for the prevention of pharyngitis caused by Streptococcus pyogenes and secondary rheumatoid arthritis.
Elderly patients.
There is no need to change the dosage for elderly patients.
Since elderly patients may have impaired electrical conduction of the heart, caution is recommended when using azithromycin due to the risk of developing cardiac arrhythmias and torsade de pointes.
Patients with renal impairment.
In patients with mild renal impairment (glomerular filtration rate 10–80 mL/min), the same dosage can be used as in patients with normal renal function. Azithromycin should be administered with caution to patients with severe renal impairment (glomerular filtration rate < 10 mL/min).
Patients with impaired liver function.
Since azithromycin is metabolized in the liver and excreted in the bile, the drug should not be used in patients with severe hepatic impairment. Studies related to the treatment of such patients with azithromycin have not been conducted.
Children.
Use in children weighing 5 to 15 kg. Children weighing more than 15 kg are recommended to use Sumamed® forte (200 mg/5 ml).
Overdose
Experience with the clinical use of azithromycin suggests that adverse reactions that develop when taking higher than recommended doses of the drug are similar to those observed with the use of usual therapeutic doses, namely: they may include diarrhea, nausea, vomiting, reversible hearing loss. In case of overdose, if necessary, administration of activated charcoal and carrying out general symptomatic and supportive treatment measures are recommended.
Side effects
The following table lists adverse reactions identified in clinical trials and during post-marketing surveillance with all formulations of azithromycin, by system organ class and frequency. Adverse reactions reported during post-marketing surveillance are in italics. The frequency groups are defined using the following convention: very common (≥ 1/10); 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); not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Adverse reactions possibly or probably related to azithromycin based on data obtained during clinical trials and during post-marketing surveillance
| System and organ class | Adverse reaction | Frequency |
| Infections and infestations | Candidiasis, vaginal infections, pneumonia, fungal infection, bacterial infection, pharyngitis, gastroenteritis, respiratory dysfunction, rhinitis, oral candidiasis | Infrequently |
| Pseudomembranous colitis | Unknown |
| Blood and lymphatic system disorders | Leukopenia, neutropenia, eosinophilia | Infrequently |
| Thrombocytopenia, hemolytic anemia | Unknown |
| On the part of the immune system | Angioedema, hypersensitivity reactions | Infrequently |
| Anaphylactic reaction | Unknown |
| Metabolic | Anorexia | Infrequently |
| From the psyche | Nervousness, insomnia | Infrequently |
| Agitation | Rarely |
| Aggression, anxiety, delirium, hallucinations | Unknown |
| From the nervous system | Headache | Often |
| Dizziness, drowsiness, dysgeusia, paraesthesia |
| Syncope, convulsions, hypoesthesia, psychomotor hyperactivity, anosmia, ageusia, parosmia, myasthenia gravis | Unknown |
| From the organs of vision | Vision impairment | Infrequently |
| From the hearing organs | Hearing disorders, vertigo | Infrequently |
| Hearing impairment, including deafness and/or tinnitus | Unknown |
| From the heart | Palpitation | Infrequently |
| Ventricular flutter/fibrillation (torsade de pointes), arrhythmia including ventricular tachycardia, ECG QT prolongation | Unknown |
| From the vascular side | Tides | Infrequently |
| Arterial hypotension | Unknown |
| From the respiratory system | Dyspnea, epistaxis | Infrequently |
| From the digestive tract | Diarrhea | Very often |
| Vomiting, abdominal pain, nausea | Often |
| Constipation, flatulence, dyspepsia, gastritis, dysphagia, abdominal distension, dry mouth, eructation, mouth ulcers, salivary hypersecretion | Infrequently |
| Pancreatitis, tongue discoloration | Unknown |
| Hepatobiliary system | Liver dysfunction, cholestatic jaundice | Rarely |
| Hepatic failure (rarely fatal), fulminant hepatitis, hepatic necrosis | Unknown |
| Skin and subcutaneous tissue disorders | Rash, pruritus, urticaria, dermatitis, dry skin, hyperhidrosis | Infrequently |
| Photosensitivity, acute generalized exanthematous pustulosis | Rarely |
| Stevens–Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms | Unknown |
| Musculoskeletal system | Osteoarthritis, myalgia, back pain, neck pain | Infrequently |
| Arthralgia | Unknown |
| From the urinary system | Dysuria, kidney pain | Infrequently |
| Acute renal failure, interstitial nephritis | Unknown |
| Reproductive system and breast disorders | Uterine bleeding, testicular disorders | Infrequently |
| General disorders and local reactions | Edema, asthenia, malaise, fatigue, facial edema, chest pain, hyperthermia, pain, peripheral edema | Infrequently |
| Laboratory indicators | Decreased lymphocyte count, increased eosinophil count, decreased blood bicarbonate, increased basophil count, increased monocyte count, increased neutrophil count | Often |
| Aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased, blood urea increased, blood creatinine increased, blood potassium changes, alkaline phosphatase increased, chloride increased, glucose increased, platelets increased, haematocrit decreased, bicarbonate increased, sodium abnormal | Infrequently |
| Injury and poisoning | Complications after the procedure | Infrequently |
Information on adverse reactions possibly associated with the prevention and treatment of Mycobacterium Avium Complex is based on data from clinical trials and post-marketing surveillance. These adverse reactions differ in type or frequency from those reported with the immediate-release and long-release formulations.
Adverse reactions possibly associated with the prevention and treatment of Mycobacterium Avium Complex
| System and organ class | Adverse reaction | Frequency |
| Metabolic | Anorexia | Often |
| From the nervous system | Dizziness, headache, paresthesia, dysgeusia | Often |
| Hypoesthesia | Infrequently |
| From the organs of vision | Vision impairment | Often |
| From the hearing organs | Deafness | Often |
| Hearing impairment, ringing in the ears | Infrequently |
| From the heart | Palpitation | Infrequently |
| From the digestive tract | Diarrhea, abdominal pain, nausea, flatulence, gastrointestinal discomfort, frequent loose stools | Very often |
| Hepatobiliary system | Hepatitis | Infrequently |
| Skin and subcutaneous tissue disorders | Rash, itching | Often |
| Stevens–Johnson syndrome, photosensitivity | Infrequently |
| Musculoskeletal system | Arthralgia | Often |
| General disorders and local reactions | Increased fatigue | Often |
| Asthenia, malaise | Infrequently |
Expiration date
2 years.
The shelf life of the finished suspension is 5 days.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children. Store the prepared suspension at a temperature not exceeding 25 °C.
Packaging
1 vial of powder for oral suspension of 20 ml (400 mg) together with a dosing syringe in a box.
Vacation category
According to the recipe.
Producer
PLIVA Hrvatska d.o.o.
Address
Prilaz baruna Filipovića 25, 10000 Zagreb, Croatia.
