Pharmacodynamics
Zanamivir is a strong and highly selective inhibitor of neuraminidase (the surface enzyme of the influenza virus). Viral neuraminidase mediates the release of viral particles from the infected cell and can accelerate the penetration of the virus through the mucosal barrier to the surface of epithelial cells, thereby allowing infection of other cells of the respiratory tract. The inhibitory activity of zanamivir has been shown both in vitro and in vivo and includes all 9 subtypes of influenza virus neuraminidases, incl. circulating and virulent for various species. For virus strains A and B, the 50% inhibitory concentration (IC50) ranges from 0.09 to 95.2 nM.
Replication of the influenza virus is limited to cells of the surface epithelium of the respiratory tract. Zanamivir acts in the extracellular space, reducing the reproduction of both types of influenza virus (A and B), preventing the release of viral particles from the surface epithelial cells of the respiratory tract. The effectiveness of zanamivir when administered inhaled has been confirmed in controlled clinical studies. The use of zanamivir as a treatment for acute influenza virus infections resulted in decreased viral release (compared to placebo). The development of resistance to zanamivir has not been recorded.
Relenza 5mg/dose 20doses dosed powder for inhalation
Latin name
Relenza
Release form
Powder for inhalation.
Package
20 doses.
pharmachologic effect
Relenza is an antiviral agent. Highly selectively inhibits neuraminidase, a surface enzyme of the influenza virus, incl. all known subtypes of influenza A virus neuraminidase, blocks the replication of influenza A and B viruses. Prevents the release of new viral particles from infected cells, the interaction of viruses with the surface of epithelial cells of the respiratory tract and their infection.
Indications
Prevention and treatment of influenza A and B in adults and children over 5 years of age.
Contraindications
Hypersensitivity to the components of the drug.
Use during pregnancy and breastfeeding
Contraindicated in the first trimester of pregnancy, in the second and third trimesters it is possible if the expected effect of therapy exceeds the potential risk to the fetus. Breastfeeding should be stopped during treatment.
special instructions
If bronchospasm develops, you should immediately stop inhalation and consult a doctor. If you have a history of respiratory tract diseases accompanied by bronchospasm, you should carry bronchodilators (for example, salbutamol) with you during the entire period of treatment.
Compound
1 dose contains zanamivir 5 mg, as well as lactose as an excipient.
Directions for use and doses
Inhalation, using a special device “Relenza Diskhaler”.
Treatment: 2 inhalations (5 mg x 2) 2 times a day for 5 days (maximum daily dose - 20 mg); It is recommended to start treatment within the first two days of the disease.
Prevention: 2 inhalations (5 mg x 2) 1 time per day for 10 days (maximum daily dose - 10 mg).
Side effects
Very rarely - bronchospasm, shortness of breath, allergic reactions (including rash, urticaria, swelling of the face and oropharyngeal mucosa).
Drug interactions
Do not combine with other inhaled drugs (including bronchodilators).
Overdose
Accidental overdose is unlikely due to dosed administration, route of administration and low bioavailability of the drug.
With inhalation use of 64 mg/day (more than 3 times the recommended daily dose), no side effects were reported. They are also not registered with parenteral use of the drug Relenza at a dose of 1.2 g/day. within 5 days.
Storage conditions
At a temperature not exceeding 30°C.
Best before date
5 years.
Pharmacokinetics
Suction. Absolute bioavailability is low and averages 2% after oral administration. After oral inhalation, approximately 10 to 20% of the administered dose is absorbed. After a single dose of 10 mg, Cmax in plasma was 97 ng/ml after 1.25 hours. The low degree of absorption leads to low systemic concentrations and insignificant AUC. The low degree of absorption persists with repeated inhalations.
Distribution. After oral inhalation, zanamivir is deposited in the respiratory tract in high concentrations, ensuring delivery of the drug to the “entry gate” of the infection. After inhalation of 10 mg of zanamivir in the epithelial layer of the respiratory tract, concentrations exceeded the average value of half the inhibitory concentration for neuraminidase by 340 times 12 hours after inhalation and 52 times after 24 hours, providing rapid inhibition of the viral enzyme. The main sites of deposition are the oropharynx and lungs (77.6 and 13.2% on average, respectively).
Metabolism and excretion. It is not metabolized and is excreted unchanged by the kidneys. T1/2 from blood plasma after oral inhalation varies from 2.6 to 5.05 hours. The total clearance ranges from 2.5 to 10.9 l/hour.
Special patient populations
Elderly. Bioavailability after administration of a therapeutic dose of 20 mg is 10–20%, resulting in negligible concentrations in the systemic circulation. No adjustment of the dosage regimen is required, since any age-related changes, which usually lead to changes in the pharmacokinetic profiles of various drugs, in this case do not affect the pharmacokinetics of zanamivir.
Children. The pharmacokinetics of zanamivir were evaluated in a controlled pediatric study in 24 patients aged 3 months to 12 years using a nebulizer (10 mg) and a dry powder inhaler (10 mg). Pharmacokinetic parameters in children did not differ from those in adults.
Patients with impaired renal function. When using therapeutic doses of 20 mg, bioavailability is low and amounts to 10–20%, therefore, systemic concentrations of zanamivir are negligible. Given the wide range of safety of the drug, a possible increase in systemic concentrations in patients with severe renal failure remains clinically insignificant and does not require adjustment of the dosage regimen.
Patients with impaired liver function. Since zanamivir is not metabolized, no dosage adjustment is required.
Clinical efficacy and safety. Zanamivir, used in doses used in the treatment of influenza, in healthy people at risk (usually in contact with sick people), alleviates symptoms and shortens the duration of the disease. A combined analysis of the 3 studies showed that the median time to symptom relief was reduced to 1.5 days in patients in the zanamivir group compared with patients in the placebo group (p<0.001). The number of complications was reduced in the zanamivir group 171/769 (22%) compared with placebo 208/711 (relative risk: 0.77; (95% CI: 0.65 to 0.92; p = 0.004). Antibiotic use for the treatment of complications after influenza also decreased from 136/711 (19%) in the placebo group to 110/769 (14%) in the zanamivir group (relative risk: 0.76; 95% CI: 0.60 to 0.95 ; p=0.021) The optimal effectiveness of zanamivir was shown if treatment was started as soon as possible after the first symptoms of the disease appeared.
Zanamivir has also been shown to be effective in preventing influenza in children over 5 years of age and in adults. The percentage of effective protection is 67–79% compared with placebo and 56–61% compared with active control.
Relenza por d/inhalation with inhaler 5 mg/dose 4 doses N5 (Glaxo)
Pharmaceutical group: Antiviral drug. Pharmaceutical action: Relenza is an antiviral drug, a highly selective inhibitor of neuraminidase (the surface enzyme of the influenza virus). Viral neuraminidase mediates the release of viral particles from the infected cell and can accelerate the penetration of the virus through the mucosal barrier to the surface of epithelial cells, thereby allowing infection of other cells of the respiratory tract. The inhibitory activity of zanamivir has been shown both in vitro and in vivo and includes all 9 subtypes of influenza virus neuraminidases, incl. circulating and virulent for various species. The half inhibitory concentration (IC50) for virus strains A and B ranges from 0.09 to 95.2 pM. Replication of the influenza virus is limited to cells of the surface epithelium of the respiratory tract. Zanamivir acts in the extracellular space, reducing the reproduction of both types of influenza A and B viruses, preventing the release of viral particles from the surface epithelial cells of the respiratory tract. The effectiveness of zanamivir when administered inhaled has been confirmed in controlled clinical studies. The use of zanamavir as a treatment for acute influenza virus infections resulted in reduced viral release (compared to placebo). The development of resistance to zanamivir has not been recorded. Clinical efficacy and safety Zanamivir, used in doses used in the treatment of influenza, in healthy people at risk (usually in contact with sick people), alleviates symptoms and shortens the duration of the disease. A combined analysis of 3 studies showed that the median time to symptom relief was reduced to 1.5 days in patients in the zanamivir group compared with patients in the placebo group (zanamivir has also been shown to be effective as a preventive measure for influenza in children over 5 years of age and in adults. The percentage of effective protection is 67-79% compared with placebo and 56-61% compared with active control. Pharmacokinetics: Absorption When administered by inhalation, the absolute bioavailability of the drug is low (average 2%). Systemic absorption is approximately 10-20% After a single dose of 10 mg, Cmax is 97 ng/ml and is achieved after 1.25 hours. Due to low absorption, the concentration of the active substance in the blood plasma is low (the low degree of absorption persists with repeated inhalations).Distribution After inhalation, zanamivir is distributed in the tissues of the respiratory tract, reaching high concentrations.When used in a single dose of 10 mg, zanamivir is detected in the epithelial layer of the respiratory tract, which is the main site of influenza virus replication. The concentration of zanamivir at 12 hours and 24 hours after inhalation is approximately 340 and 52 times higher than the mean IC50 value for viral neuraminidase, respectively. The high concentration of zanamivir in the respiratory tract provides rapid inhibition of viral neuraminidase. Zanamivir accumulates predominantly in the tissues of the oropharynx and lungs (on average 77.6% and 13.2%, respectively). Metabolism and elimination Zanamivir is excreted unchanged by the kidneys and is not metabolized. T1/2 of zanamivir after inhalation ranges from 2.6 to 5.05 hours. Total clearance is from 2.5 to 10.9 l/hour. Pharmacokinetics in special clinical situations: In elderly patients at a therapeutic dose of 20 mg/day. bioavailability is low (10-20%), as a result of which there is no systemic effect of zanamivir. Age-related changes in pharmacokinetics are unlikely (no dose adjustment required). In children, the pharmacokinetics of zanamivir were assessed in a controlled study in 24 patients aged 3 months to 12 years using a nebulizer (10 mg) and a dry powder inhaler (10 mg). Pharmacokinetic parameters in children did not differ from those in adults. In patients with impaired renal function, when using therapeutic doses of 20 mg, bioavailability is low and amounts to 10-20%, therefore, systemic concentrations of zanamivir are insignificant. Given the wide range of safety of the drug, a possible increase in systemic concentrations in patients with severe renal failure remains clinically insignificant and does not require adjustment of the dosage regimen. Since zanamivir is not metabolized, no dosage adjustment is required if liver function is impaired.
Use during pregnancy and breastfeeding
The effectiveness and safety of zanamivir during pregnancy and lactation have not been studied.
Experimental studies in animals have shown that zanamivir crosses the placenta and into breast milk, however, there was no teratogenic effect or decreased fertility or clinical manifestations of any disorders in the peri- and postnatal periods. There is no information about penetration through the placental barrier or into breast milk in humans.
However, zanamivir should not be used during pregnancy and breastfeeding, especially in the first trimester; use is possible only if the expected benefit to the mother outweighs the possible risk to the fetus.
Side effects
In controlled clinical trials, the incidence of adverse events was similar in the zanamivir group and the placebo group. Spontaneous reports contained information about adverse reactions to the use of zanamivir and were classified as follows: very often (≥1/10), often (≥1/100, <1/10), sometimes (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), including isolated cases.
From the immune system: very rarely - allergic reactions, including swelling of the face and larynx.
From the respiratory tract: very rarely - bronchospasm, difficulty breathing.
From the skin and its appendages: very rarely - rash, urticaria, severe skin reactions, including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Directions for use and doses
For oral inhalation, the included Diskhaler should be used to ensure correct use of the drug.
For patients taking other inhaled medications (eg, bronchodilators), Relenza should be used only after these medications.
Treatment
Adults and children over 5 years of age: the recommended dose of zanamivir is 2 inhalations (2x5 mg) 2 times a day for 5 days. The total daily dose is 20 mg. To achieve optimal effect, treatment should be started when the first symptoms of the disease appear.
Elderly patients: no dosage adjustment is required.
Patients with impaired renal function: no dosage adjustment is required.
Patients with impaired liver function: no dosage adjustment is required.
Prevention
Adults and children over 5 years of age: the recommended dose of zanamivir is 2 inhalations (2x5 mg) once a day for 10 days. The total daily dose is 10 mg. The duration of use can be increased to 1 month if the risk of infection persists for more than 10 days (for example, longer contact with sick people is expected).
Elderly patients: no dosage adjustment is required.
Patients with impaired renal function: no dosage adjustment is required.
Patients with impaired liver function: no dosage adjustment is required.
Instructions for using Diskhaler with rotadiscs
The Diskhaler device is used for inhalation of rotadisc (formulation of Relenza®).
The dischaler consists of the following parts:
— a housing with a lid and a plastic needle for piercing the rotadisk cell;
— cover for the mouthpiece;
- a retractable tray with a mouthpiece and a rotating wheel on which the rotadisc is placed.
The rotadisk consists of 4 blisters, each of which contains a certain dose of the drug.
The rotadisk can be stored in the Diskhaler inhalation device; however, the blister should be pierced immediately before inhalation of the drug. Failure to comply with this recommendation may interfere with the functioning of Diskhaler and, accordingly, reduce the effectiveness of the drug.
Important! The rotadisc should not be punctured before it is placed in the Diskhaler.
Loading a rotadisk into Diskhaler
1. Remove the cover from the mouthpiece, make sure the mouthpiece is clean inside and out.
2. Carefully pull out the pull-out tray until the plastic clips come out, grasping the corners of the tray. The tray should be pulled out all the way so that the notches on the side of the clamps are visible.
3. Pull the tray out completely by squeezing the notches on the side of the clamps with your thumb and forefinger.
4. Place the rotadisc on the wheel with the cells facing down and insert the tray back into the Diskhaler.
Carrying out inhalation
5. Lift the Diskhaler cover up as far as it will go to pierce the top and bottom foil of the rotadisc. Close the lid.
Important! Do not lift the cover until the drawer is fully installed.
6. After exhaling completely, place the mouthpiece between your teeth and tightly clasp the mouthpiece with your lips, without closing the air holes on both sides of the mouthpiece. Take a slow, deep breath (always through your mouth, not your nose). Remove the mouthpiece from your mouth. Hold your breath as much as possible. Exhale slowly. Do not exhale into the inhaler.
7. Carefully pull out the drawer until it stops once, without pressing the clamps, and push it in. In this case, the rotadisc will rotate one cell and is ready for the next inhalation.
Important! The cell should be pierced only immediately before inhalation!
To carry out repeated inhalations, repeat steps 5 and 6.
Replacing an empty rotadisk
Each rotadisk contains 4 cells. After 4 inhalations, replace the empty rotadisk with a new one (steps 2–4).
Important! Children should use the inhalation device under adult supervision.
Relenza powder for ing doses 5.0 mg rotadisc with dischaler N 5
Active substance
zanamivir
ATX code
J05AH01 (Zanamivir)
Release form, packaging and composition of the drug
Dosed powder for inhalation
from white to almost white.
| 1 dose | |
| zanamivir (micronized) | 5 mg |
[PRING] lactose monohydrate - up to 25 mg.
4 doses - laminated aluminum rotadisks (5) - plastic bottles (1) complete with Diskhaler (1 pc.) - cardboard packs.
Clinical and pharmacological group
Antiviral drug
Pharmacotherapeutic group
Antiviral agent
pharmachologic effect
Suction
Pharmacokinetic studies in humans have shown that the absolute bioavailability of zanamivir after oral administration is low, averaging 2%. Similar studies of zanamivir following oral inhalation indicate that approximately 10% to 20% of the administered dose is systemically absorbed and plasma Cmax is typically achieved within 1 to 2 hours after administration. The low degree of absorption of the drug leads to low systemic concentrations, i.e. Zanamivir does not have significant systemic effects after oral inhalation. There is no evidence of changes in the pharmacokinetics of the drug after repeated oral inhalations.
Distribution
The binding of zanamivir to plasma proteins is very low (<10%). The Vd of zanamivir in adults is about 16 L, which approximately corresponds to the volume of extracellular fluid.
After oral inhalation, zanamivir is deposited throughout the respiratory tract in high concentrations, ensuring delivery of the drug to the site of infection. After a single inhalation of 10 mg of zanamivir, the concentration of the drug in the epithelial layer of the respiratory tract - the main site of influenza virus replication - exceeded the average IC50 value for viral neuraminidase by approximately 340 times at 12 hours after inhalation and approximately 52 times at 24 hours after inhalation, providing rapid inhibition viral neuraminidase. Zanamivir is deposited mainly in the oropharynx and lungs (on average 77.6% and 13.2%, respectively).
Metabolism
Zanamivir is not metabolized and is excreted unchanged by the kidneys.
Removal
In adult patients with normal renal function, T1/2 of zanamivir is approximately 2-3 hours.
Pharmacokinetics in special groups of patients
Children.
The pharmacokinetics of zanamivir were evaluated in an open-label, single-dose nebulizer (10 mg) and dry powder inhaler (10 mg) study in 24 patients aged 3 months to 12 years. Systemic concentrations in children did not differ from those in adults when zanamivir 10 mg inhalation powder was administered.
Elderly patients.
With daily use of zanamivir in the form of inhalation at a therapeutic dose of 20 mg, the bioavailability of the drug is low and amounts to 10-20%, therefore systemic concentrations of zanamivir are insignificant. No dosage adjustment is required since any age-related changes in the pharmacokinetic profile are unlikely to have clinically significant effects.
Patients with impaired renal function.
With daily use of zanamivir in the form of inhalation at a therapeutic dose of 20 mg, the bioavailability of the drug is low and amounts to 10-20%, therefore systemic concentrations of zanamivir are insignificant. Given the wide range of safety of zanamivir, the possible increase in systemic concentrations in patients with severe renal failure is not considered clinically significant and does not require adjustment of the dosage regimen when used in the form of inhalation. In patients with severe renal impairment (creatinine clearance <30 ml/min), serum T1/2 increases to approximately 12-20 hours. In patients with end-stage chronic renal failure, the elimination of zanamivir has not been studied.
Patients with impaired liver function.
Since zanamivir is not metabolized, no dosage adjustment is required in patients with hepatic impairment.
Indications for use
- treatment of infection caused by influenza virus types A and B in children over 5 years of age and adults;
- prevention of infection caused by influenza virus types A and B in children over 5 years of age and adults.
Dosage
Relenza is used only by oral inhalation using the included Diskhaler device.
Patients prescribed other inhaled medications (eg, rapid-acting bronchodilators) with Relenza should be advised to use these medications prior to using Relenza.
Treatment
Adults
The recommended dose of Relenza is two inhalations (2x5 mg) 2 times a day for 5 days. The total daily dose is 20 mg. To achieve optimal effect, treatment should be started as early as possible (preferably within 2 days) when the first symptoms of the disease appear.
Correction of dosage regimen in children
not required.
Correction of dosage regimen in elderly patients
not required.
In patients with impaired renal and hepatic function
no dosage adjustment is required.
Prevention
Adults
The recommended dose of Relenza is two inhalations (2×5 mg) 1 time/day for 10 days. The total daily dose is 10 mg. The period of preventive therapy can be extended to one month if the period of risk of contact with the infectious agent exceeds 10 days.
The full course of preventive therapy must be completed as prescribed.
Correction of dosage regimen in children
not required.
In elderly patients
no dosage adjustment is required.
In patients with impaired renal and hepatic function
no dosage adjustment is required.
Instructions for using Diskhaler with Rotadiscs
The Diskhaler device is used for inhalation of zanamivir from Rotadisk.
The dischaler consists of the following parts:
- a housing with a lid and a plastic needle for piercing the Rotadisk cell;
- a retractable tray with a mouthpiece and a rotating wheel on which the Rotadisc is placed.
- case for mouthpiece.
The rotadisc is placed on the wheel.
Should not be used individually until you have read the step-by-step instructions.
Rotadisk is a blister with 4 cells, each of which contains 5 mg of zanamivir. The recommended dose of Relenza is two cells (10 mg).
Important!
The Rotadisk should not be pierced before it is installed in the Diskhaler inhalation device. The rotadisc can be stored in a Diskhaler, but the blister should be pierced immediately before inhalation of the drug. The Diskhaler should be kept clean. After use, wipe the mouthpiece with a clean cloth and cover it with a blue cover.
Loading Rotadisk into Diskhaler
1. Remove the blue cover from the mouthpiece. You should make sure that the mouthpiece is clean inside and out.
2. Carefully pull out the white drawer until the plastic clips come out, grasping the corners of the drawer. The tray should be pulled out all the way so that the notches on the side of the clamps are visible.
3. Pull out the white tray completely by squeezing the notches on the side of the clips with your thumb and forefinger.
4. Place the new Rotadisc on the wheel with the label facing up and the cells facing down. The cells should match the holes in the wheel.
5. Insert the tray back into the housing. If inhalation is not carried out immediately after installing the Rotadisk, you should put the blue cover back on the mouthpiece.
Preparation for inhalation
The Rotadisk should only be pierced immediately before inhalation.
6. Holding the Diskhaler horizontally, lift its lid up as far as it will go to pierce the top and bottom foil of the Rotadisk. The cover must be in a completely vertical position. Close the lid. Diskhaler is ready for use.
The diskhaler with a punctured Rotadisk should be held horizontally until the moment of inhalation.
Carrying out inhalation
7. Take a comfortable sitting position. Without bringing the Diskhaler to your mouth, exhale completely. Do not exhale into the inhaler. Otherwise, you can blow the powder out of the blister.
After exhaling completely, place the mouthpiece between your teeth and squeeze tightly with your lips. Do not squeeze the mouthpiece with your teeth or block the air holes on either side of the mouthpiece. Take one quick, deep breath through your mouth.
Important!
You should inhale through your mouth, not through your nose.
Remove the mouthpiece from your mouth. Hold your breath as long as possible, then exhale slowly.
Preparing the next cell (second part of the dose)
8. Pull the pull-out tray out as far as it will go (do not press the clips or remove the tray completely) and insert it back. In this case, the Rotadisk will rotate one cell and will be ready for the next inhalation. Repeat as necessary until the cell fits under the needle.
To carry out inhalation, repeat steps 6 and 7.
9. After completing the inhalation (usually using two cells), wipe the mouthpiece and cover with the blue cover.
It is important to keep the Diskhaler clean.
Rotadisk replacement
10. Each Rotadisk contains 4 cells. After four inhalations, remove the empty Rotadisk from the Diskhaler and replace it with a new one (steps 1-5).
Important!
Children should use the inhalation device under adult supervision.
Contraindications
- hypersensitivity to the components of the drug.
Carefully:
respiratory tract diseases accompanied by bronchospasm (including a history); lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
Overdose
Symptoms:
accidental overdose is unlikely due to the characteristics of the release form itself, the route of administration and the low bioavailability (10-20%) of zanamivir. When studying the use of an aqueous solution of zanamivir without lactose, inhalation (via a nebulizer) at a dose of 64 mg/day (more than 3 times the recommended daily dose), no side effects were recorded. In addition, no side effects were recorded with intravenous zanamivir administration for 5 days up to 1200 mg/day in clinical trials.
Treatment:
because Zanamivir is characterized by low molecular weight, insignificant binding to plasma proteins and low Vd; the possibility of elimination of the drug by hemodialysis is expected. Therefore, hemodialysis may be considered as a treatment option for Relenza overdose.
Side effects
Relenza is well tolerated when administered by oral inhalation.
In clinical studies that included high-risk patient groups (elderly patients and patients with certain chronic diseases), the incidence of adverse reactions was similar in the zanamivir group and the placebo group.
The adverse reactions presented below are listed according to the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows: very often (≥1/10), often (≥1/100, <1/10), infrequently (≥1/1000, <1/100), rarely (≥1/10,000, < 1/1000), very rare (<1/10,000, including isolated cases).
Frequency categories were formed based on clinical studies of the drug and post-registration surveillance.
From the immune system:
very rarely - allergic reactions, including anaphylactic and anaphylactoid reactions, swelling of the face and oropharynx.
From the nervous system:
very rarely - vasovagal reactions (were recorded in patients with influenza virus symptoms, such as fever, dehydration, observed immediately after taking Relenza).
From the mental side:
frequency unknown - convulsions, confusion, behavioral disturbances, hallucinations, agitation, restlessness, delirium have been reported with the use of Relenza in patients with influenza, mainly among children and adolescents. Seizures and neuropsychiatric symptoms have also been reported in patients with influenza who did not take Relenza.
From the cardiovascular system:
arrhythmia, fainting.
From the respiratory system:
very rarely - bronchospasm, shortness of breath.
From the skin and subcutaneous tissue:
very rarely - rash, urticaria, severe skin reactions, including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Overdose
Zanamivir does not bind to proteins and is not metabolized or altered in the liver. Clinically significant drug interactions are unlikely.
Storage conditions
The drug should be stored out of the reach of children at a temperature not exceeding 30°C. Shelf life: 7 years. Do not use after the expiration date stated on the package.
Conditions for dispensing from pharmacies
The drug is available with a prescription.
Special Instructions
Influenza virus infection may be accompanied by increased airway hyperresponsiveness. There have been very rare reports of bronchospasm and/or worsening respiratory function following inhalation of zanamivir in patients undergoing treatment for influenza; some of these patients had no history of respiratory disease. In such cases, it is necessary to stop treatment with zanamivir and consult a specialist for a medical examination. Patients with underlying respiratory conditions taking inhaled zanamivir should carry a rapid-acting bronchodilator.
In patients with severe bronchial asthma, it is necessary to evaluate the expected benefits and possible risks of using the drug. Relenza should not be prescribed unless under appropriate medical supervision. In patients with asthma and severe chronic obstructive pulmonary disease (COPD), treatment of the underlying disease should be optimized during therapy with Relenza. The patient should be informed of the potential risk of bronchospasm.
The drug Relenza, dosed powder for inhalation, should not be used to prepare a solution and administered through a nebulizer or a ventilator. There are reports of hospitalization of patients with influenza who were prescribed a solution prepared from zanamivir inhalation powder and administered through a nebulizer or ventilator. In addition, a fatal case was described in which it was reported that the lactose contained in the drug caused obstruction of the equipment. Therefore, Relenza should only be used with the included Diskhaler device.
Influenza can be accompanied by a variety of neurological and behavioral symptoms. Post-marketing reports (primarily observed in children in Japan) have included seizures, delirium, hallucinations, and disruptive behavior in patients with influenza receiving neuraminidase inhibitors, including zanamivir. These phenomena were observed predominantly in the early stages of the disease and were often characterized by sudden onset and rapid resolution. A cause-and-effect relationship between taking zanamivir and the above adverse events has not been established. If any neuropsychiatric symptoms occur, it is necessary to assess the risk-benefit ratio of further treatment with zanamivir for each individual patient.
Impact on the ability to drive vehicles and operate machinery
No data available.
special instructions
There have been very rare isolated reports of the development of bronchospasm and/or deterioration in respiratory function after the use of zanamivir, incl. without a history of previous diseases. If one of the above phenomena occurs, you should stop taking zanamivir and consult a doctor. Patients with respiratory diseases should have a short-acting bronchodilator as an emergency treatment when treated with zanamivir.
Influenza virus infection can be associated with a variety of neurological and behavioral disorders. Post-marketing reports have reported seizures, delirium, hallucinations and deviant behavior in influenza virus-infected patients receiving neuraminidase inhibitors, including zanamivir (predominantly reported in children in Japan). These phenomena were observed mainly in the early stages of the disease and often had a sudden onset and rapid outcome. A cause-and-effect relationship between taking zanamivir and the above adverse events has not been proven. If any neuropsychiatric symptoms occur, it is necessary to assess the risk-benefit ratio of further treatment with zanamivir for each individual patient.
Effect on the ability to drive a car and other mechanisms: not noted.
