Everything you want to know about our company.
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:
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:
Contraindications
The drug is contraindicated for patients:
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