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Назол Бэби 10 мл капли назальные

Availability
Not available
Model
4250369505579
Country
США
Manufacturer
Сагмел, Инк.
  • Description

Description

Instructions for medical use of

Nazol® Baby

Trade name:

Nazol® Baby

International nonproprietary name

Phenylephrine

Dosage form

Nasal drops for infants and children

Composition

1 ml of the drug contains:

Active substance:phenylephrine hydrochloride 1,25 mg;

Adjuvants: benzalkonium chloride, glycerol, macrogol 1500, disodium hydrophosphate dihydrate, potassium dihydrophosphate, disodium edetate dihydrate, purified water.

Description

Transparent solution, colored from colorless to light yellow, without a smell.

Pharmacotherapeutic group

Nasal preparations. Anti-congestants and other nasal preparations for local use.

Sympathomimetics. Phenylephrine.

Code АТХ R01AA04

Pharmacological properties

Pharmacokinetics

At local application of Phenylephrine, systemic absorption is low.

Pharmacodynamics

Phenylephrine hydrochloride is an agonist of α1-adrenergic receptors (sympathomimetic), making a vasoconstrictor effect at the expense of stimulation α1-receptors in the mucous membranes of the nose.

Infants of the first year of life have no cavernous tissue of the nasal concha, so the swelling of the nasal mucosa at rhinitis is mainly due to the blood filling of the surface arterioles on which α1-adrenomimetics (phenylephrine) effect.

Nasol Baby reduces swelling of the mucous membranes and tissue hyperemia, congestion in the nasal mucosa, and improves the patency of respiratory tracts.

Glycerin softens and moistures the irritated mucous membrane of the nasal cavity and protects it from excessive drying.

Indications

It facilitates breathing via the nose:

  • at colds, flu
  • hay fever or other allergic diseases of the upper respiratory tracts, accompanied by acute rhinitis or sinusitis
  • acute otitis media (as an aid to reduce swelling of the nasopharyngeal mucosa)

Dosage and methods of use

Being the supine position to drip into the nose, lightly pressing the pipette. To remain in this position for afew minutes.

Babies at the age from 2 months to 1 year: per 1 drop into each nostril, but no more than every 4 hours.

Babies at the age from 1 to 2 years old: per 1-2 drop into each nostril, but no more than every 4 hours.

Babies at the age from 2 to 6 years old: per 2-3 drops into each nostril, but no more than every 4 hours.

Do not exceed the recommended dosage regimen. Don't use more than four times a day. The treatment course must be no more than 3 days.

Side effect

At local use phenylephrine is well tolerated and, if the side effects occur, they are always mild and short-term.

The following is possible:

  • burning, sneezing, nose tingling
  • – allergic reactions (itching or urticaria, swelling of the hands, face or throat, chest tightness, breathing problems)
  • headache, dizziness, anxiety
  • arrhythmia and hypertension

Contraindications

The drug is contraindicated for patients:

  • with increased individual sensitivity to the ingredients of the drug
  • with severe type of hypertension
  • with acute cardiovascular diseases
  • tachyarrhythmia
  • with severe thyrotoxicosis
  • with diabetes
  • after transsphenoidal hypophysectomy
  • in case of inflammation of the skin or mucous membrane of the nasal vestibule andformation of a crust (dry rhinitis);
  • in patients receiving MAO inhibitors or patients receiving them for the previous 2 weeks
  • children at the age less 2 months.

Drug interaction

Do not intake together with other drugs containing local vasoconstrictors or antihypertensive agents.

Using simultaneously with monoamine oxidase inhibitors (MAO) or within 14 days after treatment, phenylephrine can result to the increased blood pressure. It is not recommended to intake phenylephrine together with linezolid.

Special indications

The phenylephrine-nasal containing sprays drug should be used with caution in patients with cardiovascular disease, hypertension, hyperthyroidism, angle-closure glaucoma, diabetes. These patients should ask for advice of a doctor before use.

The drug should be taken under supervision of adults.

If children under 12 years old demonstrate nervousness, dizziness or insomnia, discontinue use of the drug and consult a doctor.

The treatment duration is not more than 3 days. If the symptoms persist, you should consult a doctor.

It is recommended to use the individual vial to avoid the spread of infection.

Pregnancy and lactation
The drug is intended for children. Data on the use during pregnancy and lactation are not available.

Features of the drug effect upon the ability to drive a car or potentially dangerous mechanisms. It does not cause effects.

Overdosage

Overdose at local nasal use sometimes results to such systemic effects as increased heart rate (tachycardia) and increased blood pressure, anxiety and hallucinations.

Treatment: symptomatic.

Form of output and packing

Per 10 ml in high density polyethylene bottles with a twist cap made of polypropylene. Its pipette is made of polypropylene with a rubber cap mounted into the lid. The bottle together with the instruction on medical use in the state and Russian languages are packed together in a cardboard package.

Storage conditions

Do not store above 25 °C.

Keep out of the reach of children!

Shelf live

2 years

Do not use after the expiration date.

Conditions for drug supply

Without a prescription.

Manufacturer / packer

Istituto de Angeli S. r. l.,
50066 Reggello (Florence), Lock. Prulli 103/c, Italy.

Name and country of the Registration Certificate holder

Bayer Consumer Care AG, Switzerland

Name, address and contact details of the organization in the territory of the Republic of Kazakhstan accepting claims (offers) from consumers concerning the drug quality:

“Bayer KAZ” LLP.

Timiryazev Street, 42, Pav. 15, office 301

050057 Almaty, Republic of Kazakhstan

Tel: +7 727 258 80 40

Fax.: +7 727 258 80 39

e-mail: kz.claims@bayer.com

Address of the organization receiving claims from consumers regarding the quality of products (goods) on the territory of the Republic of Kazakhstan and responsible for post-registration supervision over the drug safety:

“Bayer KAZ” LLP.

Timiryazev Street, 42, Pavilion 15, office 301

050057 Almaty, Republic of Kazakhstan

Tel: +7 701 715 78 46 – 24 hours

Tel.: +7 727 258 80 40 (106) – during working hours

Fax.: +7 727 2588 039

e-mail: pv.centralasia@bayer.com