Rinolife (Otolaryngological product) Instructions for Use

Marketing Authorization Holder

Biopharmrus, LLC (Russia)

Contact Information

BIOPHARMRUS LLC (Russia)

Dosage Form

Rinolife

Means for washing and rinsing the nose and nasopharynx: sachet 10 pcs. in set with device for nasal shower "Rinolife"; sachet 10 or 30 pcs.

Dosage Form, Packaging, and Product Composition

Means for washing and rinsing the nose and nasopharynx in the form of a white powder.

Composition sodium chloride (NaCl) 96%, potassium chloride (KCl) 2%, sodium bicarbonate (NaHCO₃) 2%.

2.35 g±0.1 g – sachets (10) in a set with a device for nasal shower "Rinolife" – cardboard packs.
2.35 g±0.1 g – sachets (10) – cardboard packs.
2.35 g±0.1 g – sachets (30) – cardboard packs.

Therapeutic Category

Medical device for moisturizing, cleansing and protecting the mucous membrane of ENT organs

Properties

The Rinolife product is intended for washing, cleansing, clearing and moisturizing the nasal passages and sinuses and for gargling.

When the product is dissolved in warm boiled water, an isotonic solution is obtained. Due to the washing and rinsing procedure, viruses, bacteria, allergens, dust and other foreign agents are washed out of the nose and nasopharynx, cleansing, clearing, moisturizing of the nasal passages and sinuses occurs, and free nasal breathing is restored.

The prepared solution has a pH of 5.5-7.5.

Scope of Application

Of the Rinolife product

• Rhinitis, sinusitis (including allergic);
• Rhinitis in pregnant women;
• Prevention of influenza and ARVI;
• Tonsillitis (sore throat) and pharyngitis;
• Preparation for surgery and postoperative rehabilitation of the nasal cavity;
• Washing, cleansing, clearing and moisturizing the nasal passages and sinuses and gargling.

ICD codes

Dosage Regimen

Rinolife is used in medical and preventive medical institutions, as well as at home.

Nasal cavity washing

The procedure should be performed 1-2 times/day at any time convenient for the patient, but no later than 1 hour before bedtime.

In case of nasal congestion and difficulty in nasal breathing, it is necessary to instill a vasoconstrictor drug into the nose, and perform the procedure after nasal breathing is restored.

Dissolve the contents of 1 sachet in 250 ml of warm (36-37°C (96.8-98.6°F)) boiled water to obtain an isotonic solution. The prepared solution is ready for use.

Perform the nasal washing procedure.

For the product with the Rinolife nasal shower device

1. Unscrew the device cap and fill the bottle with the prepared solution (or use the bottle to prepare the solution), screw the device cap on. The device with the prepared solution is ready for use.
2. Take the device in a comfortable hand.
3. The patient needs to stand in front of the sink, lean forward and tilt their head down. Open the mouth and, without holding the breath, insert the device cap into the nostril so that the hole of the cap is directed into the nasal passage.
4. Gently squeeze the bottle with minimal pressure. In this case, the solution will irrigate the nasal passage and begin to flow out from the opposite half of the nasal passage or from the oral cavity. Do not press hard on the bottle and do not tilt your head to the side, as this may cause the solution to enter the middle ear.
5. As soon as the solution stops flowing from the opposite side of the nasal passage or oral cavity, remove the device from the nasal passage, while the bottle should remain in a compressed state. If the solution gets into the mouth, it must be spit out. It is not recommended to swallow the solution.
6. Unclench the bottle.
7. The patient needs to blow their nose gently, pinching one of the nostrils with a finger. Do not blow your nose hard, as when blowing your nose hard, liquid can enter the middle ear.
8. Repeat the procedure 2 more times.
9. Wash the second nasal passage in the same way.

For children, the procedure is carried out similarly with mandatory supervision by adults. Spraying of the solution for children under 14 years of age should be carried out by an adult.

The contents of 1 sachet are intended for the preparation of 1 dose of solution for a single use.

The device is intended for reusable use. Before the first and after each use, it is necessary to disassemble the device, wash the parts in warm soapy water, then rinse the device parts in running water and dry. Assemble the device.

When used in medical and preventive medical institutions, the device must be disinfected according to MU 287-113.

Gargling

The procedure should be performed 1-2 times/day for symptoms of tonsillitis (sore throat) and pharyngitis at any time convenient for the patient.

Dissolve the contents of 1 sachet in 250 ml of warm (36-37°C (96.8-98.6°F)) boiled water to obtain an isotonic solution. The prepared solution is ready for use.

Gargle with the warm freshly prepared solution. After rinsing, spit out the solution.

Side effects

With proper storage, transportation and use according to the instructions, there are no side effects.

Contraindications

• Complete blockage of the nasal passages;
• Inflammation of the middle ear (acute otitis and exacerbation of chronic otitis);
• Frequent nosebleeds;
• Presence of benign and malignant neoplasms in the nasal cavity and nasopharynx;
• Children under 6 years of age;
• Persons with disabilities and severe chronic diseases, as well as persons on bed rest;
• Individual intolerance to the components of the product.

Use during pregnancy and breastfeeding

During pregnancy and lactation, use after consultation with a doctor.

Special instructions

Use only warm (36-37°C (96.8-98.6°F)) freshly prepared solution.

The maximum volume of liquid used to fill the bottle is no more than 250 ml.

During the postoperative rehabilitation period, use after consultation with a doctor.

The medical device is supplied non-sterile. The surface of the device according to MU 287-113 is resistant to disinfection with a 3% hydrogen peroxide solution with the addition of 0.5% detergent according to GOST 25644-96 or a 1% chloramine solution.

The medical device, when used, transported and stored, does not have a negative impact on humans and the environment.

No special precautions are required when disposing of unused/used or expired products. In medical and preventive institutions, products and/or their packaging are disposed of as class A medical waste in accordance with SanPiN 2.1.7.1322-03. At home, products and/or their packaging are disposed of together with household waste.

Independent use is recommended for children over 14 years of age.

Storage Conditions

The product should be stored out of the reach of children at a temperature from 5°C (41°F) to 40°C (104°F) and relative air humidity not more than 80%. Do not store together with chemicals. Contact with dyes and solvents is not allowed.

Guaranteed shelf life of the product (sachets) is 3 years from the date of manufacture.

Guaranteed service life of the device is 3 years from the date of sale.

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.