Lysobact Spray with Aniseed flavour spray

Land: Armenien

Sprog: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Hent Produktets egenskaber (SPC)
12-09-2018

Aktiv bestanddel:

lysozyme (lysozyme hydrochloride), cetylpyridinium chloride

Tilgængelig fra:

Bosnalijek d.d.

ATC-kode:

առկա չէ (R02AA)

INN (International Name):

lysozyme (lysozyme hydrochloride), cetylpyridinium chloride

Dosering:

20mg/ml+ 1,5mg/ml

Lægemiddelform:

spray

Enheder i pakken:

30ml glass bottle with spraying pump and spray applicator

Recept type:

OTC

Autorisation status:

Registered

Autorisation dato:

2018-09-12

Produktets egenskaber

                                1. NAME OF THE MEDICINAL PRODUCT
LYSOBACT Spray
®
with aniseed flavour (20 + 1.5) mg/ml oromucosal spray, solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of LYSOBACT Spray solution with aniseed flavour contains:
Lysozyme hydrochloride 20.00 mg (corresponding to 800 000 FIP U)
Cetylpyridinium chloride 1.50 mg
For excipients see part 6.1.
3. PHARMACEUTICAL FORM
Oromucosal spray, solution.
Colourless to light yellow solution smelling of anis.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS

Local treatment of acute inflammatory diseases of the mouth cavity and
larynx mucosa
(stomatitis, gingivitis, aphthae).

Auxiliary treatment in laryngitis or pharyngitis.

With doctor’s recommendation, preoperative and postoperative in
tonsillectomy, larynx
surgery, injuries or abscesses and after dental extraction.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
_Method of administration _

It is recommended to use the drug for one patient only.

Before the first application, remove the plastic cap from the spray
pump.

After that, place the spray pump applicator on the spray pump by a
light press.

Applicator can be moved sideways and it ensures proper application of
spray into the
mouth cavity.

Applicator should be turned upwards at a right angle from the bottle.

Before the first application of the spray, press the spray pump
several times until the
spraying is homogenous.

Open the mouth wide, point the applicator towards the affected area
and press the spray
pump as many times as noted in the posology.

Hold your breath during the spraying. Do not swallow.

After the drug dosage, you should turn the applicator downwards to
block the spraying.
_Posology _
For a single dose, you need to press the spray pump five times. The
procedure can be repeated 3
to 6 times a day, with the minimum 2 hour intervals between the doses.
One press of the spray pump releases 0.20 ml of the solution
containing 4 mg of lysozyme and
0.3 mg of cetylpyridinium.
LYSOBACT Spray is not intended for use 
                                
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