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LORDE® hyal

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LORDE® hyal

Lorde hyal is an inhaled mucolytic with hyaluronic acid

3% sodium chloride solution is an inhaled mucolytic with osmotic mechanism of action.

Hypertonic 3% sodium chloride solution is a natural sterile solution for improving of sputum or mucus excretion, reducing of swelling and improving of breathing.

Lorde® Hyal is indicated for patients with bronchitis, bronchiolitis, bronchiectatic disease and chronic obstructive pulmonary disease.

Composition:

1 ml of the solution contains:
Sodium hyaluronate 1,0 mg;
Sodium chloride 30,0 mg.

CE 1936

Description

INSTRUCTION FOR USE FOR LORDE hyal

Sterile solution for inhalation and intranasal administration

LORDE hyal sterile solutions for inhalation by nebulizer and/or in tranasal administration by direct instillation from the container into the nasal cavity, 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 and chronic bronchitis, acute bronchiolitis, cystic fibrosis and other conditions requiring sputum dilution and evacuation) due to the osmotic effect.

Qualitative composition

LORDE hyal

Sodium chloride – 30.0 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 containing 3% saline solution.

Each package contains:

10 plastic containers with sterile  LORDE hyal solution or 60 plastic containers with sterile LORDE hyal solution.

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

 

Indications

LORDE hyal are indicated for patients with bronchitis, bronchiolitis, cystic fibrosis, and chronic obstructive respiratory diseases. It is also indicated in the case of nasopharynx diseases, diseases of the nasal cavity, adenoid hypertrophy in children, perennial and seasonal allergic rhinitis, to reduce mucosal edema, to fluidify secretion and to facilitate breathing.

Route of administration

By inhalation

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

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

By intranasal administration

Intranasal administration of the solution can be performed by squeezing the plastic container and allowing the content to flow into each nasal cavity. Use one, 4 ml vial from 1 to 4 times a day or according to medical prescription. Apply up to 4 weeks or according to medical prescription.

Warnings and special precautions for use

  • The solution is only intended for use via inhalation or intranasal administration. 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 reuse. 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 hazard.

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 other products as this may alter their action which can impair the effectiveness of the treatment.
  • If a tendency to develop dyspnea or hypersensitivity is present, LORDE and LORDE hyal must not be used without medical supervision.

Side effects

LORDE hyal 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, pre-medication with bronchodilators that can help prevent bronchospasmic reactions is advisable at the start of the treatment. Pre-medication 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.

For intranasal administration:

  • 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.
  • Squeeze the solution from the plastic container inside the nasal cavities.

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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