Rhinomaris nasal spray 0.1% fl. 15ml

Release form, composition and packaging.

Nasal spray 0.1% in the form of a clear, odorless, transparent solution.

10 ml

xylometazoline hydrochloride 10 mg

Excipients: water of the Adriatic Sea - 2.4162 g, potassium dihydrogen phosphate - 4.9 mg, purified water - up to 10 ml.

10 ml - plastic bottles (1) with a dosing device and a spray head - cardboard packs.

Clinical and pharmacological group: Vasoconstrictor drug for local use in ENT practice

Pharmaco-therapeutic group: Decongestant - vasoconstrictor (alpha-adrenergic agonist)

pharmachologic effect

A vasoconstrictor drug for intranasal use.

Xylometazoline has an alpha-adrenomimetic effect: it causes narrowing of the blood vessels of the nasal mucosa and thus eliminates edema and hyperemia of the nasopharyngeal mucosa.

Eases nasal breathing with rhinitis.

In therapeutic concentrations, it does not irritate the mucous membrane, does not cause hyperemia.

The effect occurs within a few minutes after application and lasts for 12 hours.

Sterilized sea water, which is part of the Rinomaris preparation, helps to maintain the normal physiological state of the nasal mucosa, dilute mucus and normalize its production in the goblet cells of the nasal mucosa.

Trace elements improve the function of the ciliated epithelium, which helps to reduce side local reactions, such as irritation and / or dryness of the nasopharyngeal mucosa.

Pharmacokinetics

When applied topically, the drug is practically not absorbed.

The concentrations of the active substance in the blood plasma are so low that they cannot be determined by modern analytical methods.

Indications

- acute respiratory diseases with symptoms of rhinitis (rhinitis)

- allergic rhinitis (hay fever)

- sinusitis

- eustachitis

- otitis media (to reduce swelling of the nasopharyngeal mucosa)

- preparation of the patient for diagnostic manipulations in the nasal passages.

Dosage regimen

Rinomaris nasal spray 0.05%

Children aged 2 to 6 years: 1 injection into each nostril 1-2 times / day.

Children over 6 years old: 1 injection into each nostril 2-3 times / day.

Rhinomaris nasal spray dosed 0.1%

Children over 6 years old and adults: 1 injection into each nostril 2-3 times / day.

The drug should not be used more than 4 times / day.

The duration of the course is no more than 5-7 days.

Side effect

From the respiratory system: with frequent and / or prolonged use - irritation and / or dryness of the nasopharyngeal mucosa, burning, tingling, sneezing, hypersecretion, swelling of the nasal mucosa.

From the side of the cardiovascular system: palpitations, tachycardia, arrhythmias, increased blood pressure.

From the nervous system: headache, insomnia

with prolonged use in high doses - depression.

Others: vomiting, visual impairment.

Contraindications for use

- arterial hypertension

- tachycardia

- severe atherosclerosis

- glaucoma

- atrophic rhinitis

- thyrotoxicosis

- Surgical interventions on the meninges (in history)

- children under 6 years of age (for nasal spray 0.1%)

- children under 2 years of age (for nasal spray 0.05%)

- hypersensitivity to drug components.

The drug should be used with caution in diabetes mellitus, ischemic heart disease.

Application during pregnancy and lactation

During pregnancy and lactation (breastfeeding), the drug should be used only after a careful assessment of the risk-benefit ratio for the mother and the fetus or infant.

Do not exceed the recommended doses.

Application in children

Name ENG

RHINOMARIS

Clinical and pharmacological group

A vasoconstrictor drug for local use in ENT practice

ATX code

Xylometazoline)

Dosage

0.1% x 15ml

Structure

Xylometazoline hydrochloride 10 mg.

Excipients: water of the Adriatic Sea - 2.4162 g, potassium dihydrogen phosphate - 4.9 mg, purified water - up to 10 ml.

Indications

acute respiratory diseases with symptoms of rhinitis (rhinitis)

allergic rhinitis (hay fever)

sinusitis

eustachitis

otitis media (to reduce swelling of the nasopharyngeal mucosa)

preparation of the patient for diagnostic manipulations in the nasal passages.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 3 years

INN / Active ingredient

xylometazoline

Contraindications

arterial hypertension

tachycardia

severe atherosclerosis

glaucoma

atrophic rhinitis

thyrotoxicosis

surgical interventions on the meninges (in history)

children under 6 years of age (for nasal spray 0.1%)

children under 2 years of age (for nasal spray 0.05%)

hypersensitivity to drug components.

The drug should be used with caution in diabetes mellitus, ischemic heart disease.

Specifications

Category

Runny nose

Scope of the drug

Ear, Throat, Nose

Release form

Spray

Manufacturer country

Croatia

Package quantity, pcs

one

Scope of application

Virology

Minimum age from

6 years

Way of introduction

Through the respiratory tract

Vacation conditions

Without recipe

Volume, ml.

15 ml

Brand name

Jadran

The amount of the dosage form in the primary package

15 ml

Primary packaging type

Bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Decongestant - alpha adrenergic agonist

Anatomical and therapeutic characteristics

R01AA07 Xylometazoline

Dosage form

Nasal spray

Expiration date in days

1095

Dosage (volume) of the substance in the preparation

10 mg

The target audience

Children

Package weight, g

25

Mode of application

:

Children over 6 years old and adults: 1 injection into each nostril 2-3 times / day. < br> The drug should not be used more than 4 times / day.

The duration of the course is no more than 5-7 days.

Information on technical characteristics, delivery set, country of manufacture