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OKISTAR HYAL 7

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OKISTAR HYAL 7

Okistar hyal 7 is an inhaled mucolytic with hyaluronic acid for patients with cystic fibrosis

7% sodium chloride solution is an inhaled mucolytic with osmotic mechanism of action.

Hyaluronic acid reduces the irritation caused by hypertonic salt solution when inhaled.

Okistar Hyal 7 is indicated for patients with bronchitis, cystic fibrosis, bronchiectatic disease and chronic obstructive pulmonary disease (COPD) to fluidify the mucosal secretion in the lower respiratory tract and to facilitate breathing.

Composition:

1 ml of the solution contains:
Sodium hyaluronate 1,0 mg;
Sodium chloride 70,0 mg.

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Description

INSTRUCTION FOR USE FOR OKISTAR hyal 7

Sterile solution for inhalation

OKISTAR hyal 7 sterile solutions for inhalation by nebulizer, facilitating breathing by fluidifying the secretion and improving its discharge from the mucous membrane of the upper and lower respiratory tract in cases of mucus accumulation (acute bronchiolitis, cystic fibrosis and other conditions requiring sputum dilution and evacuation from upper and lower respiratory tract) due to the osmotic effect.

OKISTAR hyal 7

Sodium chloride – 70.0 mg/ml

Sodium Hyaluronate – 1.0 mg/ml

Water for injection

Classification of the product

Medical device – sterilized and pyrogen-free.

Class IIa.

Package

4 ml in pre-filled disposable polymer containers. Each package contains:

10 plastic containers with sterile OKISTAR hyal 7 solution or 60 plastic containers with sterile OKISTAR hyal 7 solution.

attempOnly the contents of the package are sterile. The medical device has been sterilized by steam sterilization.

Indications

OKISTAR hyal 7 are indicated for patients with bronchitis, bronchiolitis, cystic fibrosis, chronic obstructive respiratory diseases, bronchial asthma in adults and children and other conditions requiring sputum dilution and evacuation from upper and lower respiratory tract, to reduce mucosal edema, to fluidify secretion and to facilitate breathing .

Route of administration

The solution can be inhaled by means of a nebulizer using a facemask, an actuator or a nasal cannula, and following the nebulizer manufacturer’s instructions for use.

Use one, 4 ml vial twice a day or according to medical prescription.

Warnings and special precautions for use

  • The solution is only intended for use via inhalation. Do not inject.
  • The first administration of the solution should be under the supervision of a doctor or qualified medical staff.
  • In case of bronchial spasm or cough, discontinue the administration and consult a doctor.
  • Do not use if the solution is not transparent and colorless.
  • Do not use if the package is opened or damaged.
  • The product must be used immediately after opening.
  • The product is intended for single. After use, the unused product is no longer sterile.
  • Do not Once the product has been used for the first time, any residuals of the product are not suitable for the repeated use as the product is no longer sterile.
  • Do not re-sterilize. Repeated sterilization may cause cross-contamination.
  • Do not freeze.
  • The product must not be administered orally.
  • The use by children should be under the supervision of adults.
  • This product includes small parts, which can pose a choking. Always keep this product out of the reach of children under the age of three.

Special warnings

  • Do not use after the expiry date.
  • Do not use the solutions in combination with drugs or agents as this may alter their action which can impair the effectiveness of the treatment.
  • If a tendency to develop dyspnea or hypersensitivity is present OKISTAR hyal 7 must not be used without medical supervision.

Side effects

OKISTAR hyal 7 are contraindicated in case of individual hypersensitivity to any component of the product.

In persons with individual intolerance to the solution components allergic reactions are possible.

Hypertonic saline solution can cause reversible constriction of the bronchia when inhaled by very sensitive patients with bronchial asthma or a hyperreactive bronchial system. In particularly susceptible subjects, premedication with bronchodilators that can help prevent bronchospas- mic reactions is advisable at the start of the treatment. Premedication with bronchodilators must be carried out under the control of a doctor.

In case of the onset of bronchospasms or persistent cough, interrupt the treatment and inform the treating doctor.

How to use

For inhalation by nebulizer:

  • Check the expiry date indicated on the package. Do not use after the expiry date
  • Take one of the plastic containers from the strip of 10 plastic containers.
  • Open the plastic container turning the stopper.
  • Use the solution in conjunction with the nebulizer following the device manufacturer’s instructions for use.

Shelf life

2 years in intact packaging.

How to store

Store at a temperature from 5° to 30° C (inclusive), away from direct light and heat sources, in the adequately closed packaging.

The expiry date applies to the product when correctly stored in intact packaging.

Disposal

The product must be disposed in accordance with applicable laws on municipal waste.

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