Sinuforte lyof. d / inv. solution for intranaz. entered fl. 50mg (complete with solution and spray nozzle)

Release form, composition and packaging

Lyophilisate for preparation of a solution for intranasal administration from white to light brown, hygroscopic

the prepared solution is from colorless to light yellow.

1 fl.

lyophilisate of juice and extract of fresh tubers of European cyclamen (hemolytic index 1: 6000-1: 12000) 50 mg

Solvent: water d / i - 5 ml.

50 mg - flasks of colorless glass (1) complete with a solvent (polyethylene bottles 1 pc.) And a spray nozzle - plastic trays (1) - cardboard packs.

pharmachologic effect

A herbal preparation for the treatment of inflammatory diseases of the paranasal sinuses (SNP) and nasal cavity. The drug acts on the sensory receptors of the trigeminal nerve in the middle nasal passage and causes reflex secretion in the mucous membrane of the nasal cavity and SNP. Stimulated hypersecretion is accompanied by a change in the rheological properties of the secretion and the normalization of its viscosity. Reflex hypersecretion in combination with the anti-edematous action of the drug leads to the evacuation of secretions from the sinuses into the nasopharynx and provides physiological drainage of all sinuses at the same time. The drug helps to restore mucociliary transport in the nasal cavity and SNP by increasing the presence of the liquid part of the secretion in the surface layer of mucus. Sinuforte enhances blood microcirculation in the nasal mucosa and SNP. This is due to the factthat parasympathetic stimulation, which activates secretion, also causes vasodilation of the vessels supplying the glands.

Enhanced reflex secretion in the form of serous-mucosal secretions is detected after a few minutes and can last from 30 to 120 minutes, depending on the individual characteristics of the organism.

Pharmacokinetics

The action of the drug Sinuforte is due to the combined effects of the components of cyclamen, the most studied of which are triterpene saponins.

Carrying out kinetic studies is not possible, since all the components together cannot be traced using markers or bioassays.

For the same reason, drug metabolites cannot be detected.

Indications for use

- complex therapy of acute and chronic sinusitis: sinusitis, frontal sinusitis, ethmoiditis and sphenoiditis (in the case of purulent sinusitis, occurring with symptoms of generalization of infection and / or orbital complications, Sinufort should be used only in combination with antibiotics).

With an uncomplicated course of the disease, it is possible to use the drug as a means of monotherapy under the supervision of a physician

- complex therapy of rhinosinusitis, accompanied by exudative otitis media

- the period of early postoperative rehabilitation after endoscopic surgical interventions on the paranasal sinuses.

Contraindications for use

- hypersensitivity to drug components

- polypous rhinosinusitis

- cysts of the paranasal sinuses

- allergic rhinosinusopathies

- allergic reactions (delayed and immediate type)

- arterial hypertension II-III stage

- pregnancy and lactation period (safety of use during these periods has not been studied)

- children under 5 years of age (use in children under 5 years of age has not been studied).

Dosage regimen

Intranasally.

Adults and children over 5 years old:

- With each press, the dispenser sprays 0.13 ml (2-3 drops) of the drug, which is about 1.3 mg of the drug (single dose).

- The drug prepared in the above way is injected once a day by a single spray into each nasal passage.

It is preliminarily recommended to do 2-3 test sprays into the air.

- The drug is recommended to be used daily, if necessary, it can also be used every other day.

- The duration of one course of treatment is 12-16 days when the drug is administered every other day

Name ENG

SINUFORTE

Clinical and pharmacological group

Phytopreparation with secretolytic and secretomotor action for local use in diseases of the paranasal sinuses

ATX code

Other drugs for the treatment of respiratory diseases

Dosage

50mg x 50mg

Structure

1 bottle with lyophilisate for preparation of solution for intranasal administration contains: Active ingredient: lyophilisate of juice and extract of fresh European cyclamen tubers 50 mg

Solvent: water for injection - 5 ml.

Indications

acute and chronic sinusitis (catarrhal and purulent sinusitis, frontal sinusitis, ethmoiditis, sphenoiditis, combined sinusitis)

postoperative rehabilitation after endoscopic surgical interventions (ethmoidotomy, maxillary ethmoidotomy, frontal ethmoidogymorotomy).

In these cases, intranasal administration of Sinuforte is recommended on the second day after surgery to cleanse the paranasal sinuses and nasal cavity and reduce swelling of the mucous membranes.

Storage conditions and periods

In a dark place at a temperature not exceeding 25 degrees.

Expiration date: 5 years

after preparation - 15 days (in a dark place, at a temperature of 2-8 degrees)

Contraindications

cystic-polyposis rhinosinusitis

allergic rhinosinusopathies

acute allergic reactions in the nasal mucosa and in the face area

arterial hypertension II-III degree

pregnancy

lactation period (breastfeeding)

children under 12 years of age (clinical data on the effectiveness and safety of use are insufficient)

hypersensitivity to drug components.

INN / Active ingredient

Cyclamena European Tuber Fresh Juice and Extract

Specifications

Category

Runny nose

Scope of the drug

Ear, Throat, Nose

Release form

Solution

Manufacturer country

Spain

Package quantity, pcs

one

Minimum age from

5 years

Way of introduction

Intranasally

Vacation conditions

Without recipe

Brand name

Labiana Farmaceutica

The amount of the dosage form in the primary package

50 mg

Primary packaging type

Bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Nose diseases remedy

Expiration date in days

1825

The target audience

Children

Package weight, g

55

Mode of application

:

Intranasal, adults and children over 5 years old. < br> The sequence of actions when using the drug < br> 1. Unscrew the cap from the bottle with the drug and remove the stopper. < br> 2. Open the solvent bottle, break off the upper part. < br> 3. Completely pour the contents of the solvent into the vial with the preparation. < br> 4. Screw the dispenser onto the bottle and shake until the drug is completely dissolved. < br> 5. Remove the protective cap from the dispenser spray. < br> 6. Perform 2–3 test sprays into the air. < br> 7. With the vertical position of the head, a nebulizer-dispenser is introduced into each nasal passage, holding the breath and spraying with one press. < br> With each press, the dispenser sprays 0.13 ml (2-3 drops) of the drug, which is about 1.3 mg of the drug (single dose). < br> The drug prepared by the above method is administered once a day by a single spray into each nasal passage. < br> The drug is recommended to be used daily, if necessary, it can be used every other day. < br> The duration of one course of treatment is 12-16 days with the introduction of the drug every other day or 6-8 days with daily use.

Components

:

water for injection (polyethylene bottles) 5 ml, spray nozzle

Anatomical and therapeutic characteristics

:

R01AX Topical preparations for the treatment of nasal diseases

Dosage form

:

Lyophilisate for preparation of solution for intranasal administration

Dosage (volume) of the substance in the preparation

:

lyophilisate of juice and extract of fresh tubers of European cyclamen 50 mg

Information on technical characteristics, delivery set, country of manufacture