Pulmozyme (dornase alfa) solution for inhalation 2.5 mg/2.5 ml. ampoules №6

Description

Pulmozyme (dornase alfa) solution for inhalation 2.5 mg/2.5 ml. ampoules №6

Composition 

active ingredient: dornase alfa;

1 ampoule (2.5 ml) of inhalation solution contains dornase alfa1 2.5 mg;

excipients: sodium chloride; calcium chloride, dihydrate; water for injections.

1 mg of dornase alfa corresponds to 1000 units.

Medicinal form

Transparent colorless or slightly yellowish solution.

Pharmacotherapeutic group

Mucolytic agents. Dornase alpha (deoxyribonuclease).
ATX code R05C B13.

Pharmacological properties

This drug Pulmozyme belongs to a group of mucolytic drugs prescribed to thin the secreted sputum.
The preparation contains dornase alpha – recombinant human DNase. This substance is a genetically engineered version of a natural enzyme secreted by the human body, which has the property of cleaving extracellular DNA.

Viscous purulent secretion, accumulating in the respiratory tract of a person, leads to disruption of external respiratory function and exacerbation of infection in patients suffering from cystic fibrosis.

The purulent secretion contains a high concentration of extracellular DNA, or viscous polyanion. The latter has the property of being released from leukocytes, breaking down and accumulating as a result of infection.

When inhaled, dornase alfa promotes the hydrolysis of DNA in sputum, and causes a significant decrease in the viscosity of sputum in cystic fibrosis.

Indications

This drug Pulmozyme is intended for the treatment of symptoms of cystic fibrosis (in the complex standard therapy) in patients over the age of 5 years.

The forced vital capacity of the lungs (FVC) is not less than 40% of normal to improve lung function.

Contraindications

Not applicable if the patient has hypersensitivity (allergy) to one of the components that make up the drug.

Children

It is not used in pediatrics under the age of 5 years.

Application during pregnancy and lactation

It is permissible to use with caution for the treatment of pregnant women.
During treatment, lactation (breastfeeding) should be suspended.

Method of administration and dosage

The solution is used exclusively for inhalation.
Do not dilute or mix with other drugs in a nebulizer container.
It is recommended to use 1 ampoule per day, using a nebulizer.

Over the age of 21, it is permissible to use the drug in the same dosage, 2 times a day.
The best results are achieved with regular daily use of the drug.
Interruptions in treatment neutralize previously achieved results of treatment, which has been proven in clinical trials.

Physiotherapy, therapeutic exercises, chest massages are also recommended.
Exacerbation of the disease is not a contraindication for the use of this drug.
The safety and efficacy of this drug has not been established for patients in the age group under 5 years old, as well as for patients with FVF less than 40% of the norm.

Overdose

Overdose with a significant excess of the dose did not cause symptoms of intoxication and did not cause changes in the clinical parameters of blood, did not affect the course of the disease.

Side effects

Usually, this drug is well tolerated, and those that appear are usually mild and do not require dose adjustment.
In particular, there may be observed:

• conjunctivitis;
• hoarseness of the vocal cords (usually caused by mechanical irritation of the ligaments associated with increased cough due to increased sputum waste), shortness of breath, pharyngitis, laryngitis, rhinitis (non-infectious), cough;
• dyspepsia;
• rash, urticaria;
• pleural chest pain, fever;
• decrease in respiratory function indicators.

At the beginning of treatment with this drug, like any aerosol, lung function may slightly decrease, and sputum discharge may increase.
If you have any unusual side effects as a result of taking this drug, you should consult your doctor about possible changes in the treatment regimen.