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Aqualor Baby (Aerosol, Otolaryngological product) Instructions for Use

Properties

The nasal cavity wash product for children and adults Aqualor Baby and Aqualor Baby Mini is used for the prevention and complex treatment of acute and chronic inflammatory diseases of the nasal cavity, paranasal sinuses and nasopharynx (infectious, allergic, atrophic), conditions after surgical interventions in the nasal cavity and paranasal sinuses, during the period of increased incidence of colds, as well as for daily hygiene of the nasal cavity and nasopharynx.

The product is intended for removing mucus, reducing discharge, softening and removing crusts, and moisturizing the nasal mucosa.

The use of Aqualor Baby and Aqualor Baby Mini products has a beneficial effect on the mucous membrane of the nasal cavity and nasopharynx, helps reduce nasal congestion and restore nasal breathing.

After washing the nasal cavity with Aqualor Baby and Aqualor Baby Mini products, the therapeutic effectiveness of drugs applied to the nasal mucosa increases, the duration of respiratory diseases is reduced, and the risk of infection spreading to the paranasal sinuses and ear cavity is reduced.

The nozzles of Aqualor Baby and Aqualor Baby Mini are equipped with a restrictive ring that prevents deep penetration and trauma to the child’s nasal mucosa; the spray type is a soft shower.

Scope of Application

Of the Aqualor Baby product

  • Prevention and complex treatment of acute and chronic inflammatory diseases of the nasal cavity, paranasal sinuses and nasopharynx (infectious, allergic, atrophic), including:
    • Rhinitis (including allergic and vasomotor);
    • Subatrophic rhinitis (dryness of the mucous membrane);
    • Sinusitis (including sinusitis);
    • Adenoiditis.
  • Prevention and complex treatment of respiratory infections (including ARVI);
  • Daily hygiene of the nasal cavity and nasopharynx;
  • Condition after surgical interventions in the nasal cavity and paranasal sinuses.

ICD codes

ICD-10 code Indication
J00 Acute nasopharyngitis (common cold)
J01 Acute sinusitis
J06.9 Acute upper respiratory infection, unspecified
J30.0 Vasomotor rhinitis
J30.1 Allergic rhinitis due to pollen
J30.3 Other allergic rhinitis (perennial allergic rhinitis)
J31.0 Chronic rhinitis (including ozaena, atrophic and hypertrophic rhinitis)
J32 Chronic sinusitis
J35.8 Other chronic diseases of tonsils and adenoids
Z29.8 Other specified prophylactic measures
Z98.8 Other specified postprocedural states
ICD-11 code Indication
CA00 Acute nasopharyngitis
CA01 Acute rhinosinusitis
CA07.0 Acute upper respiratory tract infection of unspecified site
CA08.00 Allergic rhinitis due to pollen
CA08.03 Other allergic rhinitis
CA08.3 Vasomotor rhinitis
CA09.0 Chronic rhinitis
CA0A.Z Chronic rhinosinusitis, unspecified
CA0F.Z Chronic diseases of tonsils and adenoids, unspecified
QB6Z Surgical or postprocedural conditions, unspecified
QC05.Z Prophylactic measures, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Otolaryngological product

The product is used intranasally.

Aqualor Baby and Aqualor Baby Mini are used in children from birth.

Before using the medical device, it is necessary to treat the anatomical nozzle with boiling water or a solution of ethyl alcohol.

Method of application

Nasal washing in young children (under 2 years old) is carried out in a lying position

  • Turn the child’s head to the side;
  • Insert the tip of the canister into the upper nasal passage, rinse the nasal cavity for several seconds;
  • Remove the remaining washing fluid using an aspirator, repeat the procedure if necessary.

Perform the procedure with the other nasal passage.

Nasal washing in children over 2 years old and adults

  • Tilt the head to the side;
  • Insert the tip of the canister into the upper nasal passage, rinse the nasal cavity for several seconds;
  • Remove the remaining washing fluid using an aspirator in a child/blow the nose, repeat the procedure if necessary.

Perform the procedure with the other nasal passage.

Contraindications

  • Individual intolerance to the components.

Use during pregnancy and breastfeeding

Pregnancy and breastfeeding are not contraindications to the use of Aqualor Baby and Aqualor Baby Mini products.

Special instructions

Aqualor Baby and Aqualor Baby Mini are intended for individual use and in medical institutions.

The product does not contain preservatives.

Aerosol

To facilitate the procedure before using the Aqualor Baby nasal aspirator, it is recommended to wash the child’s nasal cavity with a solution based on sea water, for example, with Aqualor Baby drops or gentle spray (1-2 sprays or a few drops into the child’s nose).

Method of application

  1. Insert the filter and put the flexible nasal applicator on the Aqualor Baby nasal aspirator.
  2. Place the mouthpiece in your mouth, and then place the nasal applicator into the child’s right nasal passage.
  3. Gently inhale through the mouth.
  4. Repeat the procedure by placing the nasal applicator into the child’s left nasal passage.

After completing the procedure, it is necessary to disassemble the Aqualor Baby nasal aspirator and wash each part with warm water and soap; do not boil. The filter should be removed and disposed of.

The filter must be changed after each use of the device.

Side effects

There are no undesirable phenomena associated with the use of the Aqualor Baby nasal aspirator with accessories.

Contraindications

No contraindications have been identified.

Special instructions

The Aqualor Baby nasal aspirator is intended for use at home.

The nasal aspirator with accessories is resistant to sanitary treatment.

The product does not require special technical maintenance during operation. Repair of the product is not provided.

The Aqualor Baby nasal aspirator, after the expiration date, is disposed of in accordance with applicable national legislative norms together with other household waste.

Storage Conditions

The product should be stored out of the reach of children, in a dry place, protected from direct sunlight, at a temperature from 5°C (41°F) to 25°C (77°F).

Shelf Life

Shelf life – 3 years. Use by the date indicated on the packaging.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Aqualor, LLC (Russia)

Manufactured By

Aurena Laboratories, AB (Sweden)

Or

YS Lab (France)

Contact Information

NIZHPHARM group of companies (Russia)

Dosage Form

Bottle OTC Icon Aqualor Baby Product for washing the nasal cavity for children: 15 ml dropper bottle
Product for washing the nasal cavity for children: 15 ml dropper bottle

Dosage Form, Packaging, and Product Composition

Product for washing the nasal cavity for children in the form of a transparent colorless liquid without odor, with a slightly salty taste.

100 ml
Natural sea water 30-33 ml
With an isotonic concentration of NaCl – 8-11 g/l
PH 6.0-8.5

Excipients: purified water.
Does not contain preservatives.

15 ml – plastic dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

Aqualor, LLC (Russia)

Manufactured By

Laboratoires Chemineau (France)

Or

YS Lab (France)

Or

Aurena Laboratories, AB (Sweden)

Contact Information

NIZHPHARM group of companies (Russia)

Dosage Forms

Bottle OTC Icon Aqualor Baby Mini Product for irrigation and washing of the nasal cavity for children and adults: 50 ml canister with anatomical nasal nozzle
Aqualor Baby Mini Product for irrigation and washing of the nasal cavity for children and adults: 50 ml canister with anatomical nasal nozzle
Aqualor Baby Mini Product for irrigation and washing of the nasal cavity for children and adults: 50 ml canister with anatomical nasal nozzle
Aqualor Baby Product for irrigation and washing of the nasal cavity for children and adults: 125 ml or 150 ml canisters with anatomical nasal nozzle
Aqualor Baby Product for irrigation and washing of the nasal cavity for children and adults: 125 ml or 150 ml canisters with anatomical nasal nozzle
Aqualor Baby Product for irrigation and washing of the nasal cavity for children and adults: 125 ml or 150 ml canisters with anatomical nasal nozzle

Dosage Form, Packaging, and Product Composition

Product for irrigation and washing of the nasal cavity for children and adults (aerosol) in the form of a transparent colorless liquid without odor, with a slightly salty taste.

100 ml
Natural sea water 30-33 ml
With an isotonic concentration of NaCl – 8-11 g/l
PH 6.0-8.5

Excipients: purified water.
Does not contain preservatives.

125 ml – metal canisters (1) with an anatomical nasal nozzle with a “soft shower” type spray – cardboard packs.
150 ml – metal canisters (1) with an anatomical nasal nozzle with a “soft shower” type spray – cardboard packs.

Aqualor Baby Mini

Product for irrigation and washing of the nasal cavity for children and adults (aerosol) in the form of a transparent colorless liquid without odor, with a slightly salty taste.

100 ml
Natural sea water 30-33 ml
With an isotonic concentration of NaCl – 8-11 g/l
PH 6.0-8.5

Excipients: purified water.
Does not contain preservatives.

50 ml – metal canisters (1) with an anatomical nasal nozzle with a “soft shower” type spray – cardboard packs.

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

YS Lab (France)

Contact Information

NIZHPHARM group of companies (Russia)

Dosage Form

Bottle OTC Icon Aqualor Baby Nasal aerosol in a set with 3 filters; accessories for nasal aspirator (10 filters and 1 nasal applicator)

Dosage Form, Packaging, and Product Composition

Nasal aspirator consists of a set of plastic parts: reusable nasal applicator, specially adapted to the anatomical features of a child’s nose; reservoir designed for collecting mucus; replaceable filter that facilitates aspiration; body equipped with an ergonomic part for convenient hand grip; long flexible tube; mouthpiece.

The nasal aspirator is supplied assembled, complete with 3 replaceable disposable filters, in a plastic storage case.
Accessories for the nasal aspirator: 10 replaceable disposable filters and 1 nasal applicator in a sealed plastic bag, packaged in a cardboard box.

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