Lysobact Complete Spray spray

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Werkstoffen:

lysozyme (lysozyme hydrochloride), cetylpyridinium chloride, lidocaine (lidocaine hydrochloride)

Beschikbaar vanaf:

Bosnalijek d.d.

ATC-code:

առկա չէ (R02AA)

INN (Algemene Internationale Benaming):

lysozyme (lysozyme hydrochloride), cetylpyridinium chloride, lidocaine (lidocaine hydrochloride)

Dosering:

20mg/ml+ 1,5mg/ml+ 0,5mg/ml

farmaceutische vorm:

spray

Eenheden in pakket:

30ml glass bottle with spraying pump and spray applicator

Prescription-type:

OTC

Autorisatie-status:

Registered

Autorisatie datum:

2018-09-12

Productkenmerken

1. NAME OF THE MEDICINAL PRODUCT
Lysobact COMPLETE Spray
®
(20 + 1.5 + 0.5) mg/ml spray for topical application
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of Lysobact COMPLETE Spray
®
contains:
Lysozyme hydrochloride
20.00 mg (corresponding to 800 000 FIP U
[International Pharmaceutical Federation units])
Cetylpyridinium chloride
1.50 mg
Lidocaine hydrochloride
0.50 mg
For excipients see section 6.1.
3. PHARMACEUTICAL FORM
Spray for topical application.
Colourless to light yellow solution with peppermint odour.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Infectious and inflammatory diseases of the mouth and throat:

Local
treatment
of acute inflammatory diseases of the mouth cavity and throat
mucosa
such as gingivitis (gum disease),
stomatitis (inflammation of the mouth cavity mucosa)
and aphthae (small wounds on the mouth mucosa).

Supporting complex therapy in sore throat
and painful
swallowing,
inflammation of the
pharyngitis and the laryngitis.

Upon the doctor's recommendation in the preoperative and postoperative
periods with
tonsillectomy,
surgical
interventions
on the larynx,
traumas
and abscesses,
and after
extraction of the tooth
4.2.DOSAGE AND METHOD OF ADMINISTRATION
_Method of administration_
1.3.1 Summary of Product Characteristics
SmPCD004864/1
LYSOBACT COMPLETE SPRAY (20 + 1.5 + 0.5) mg/ml oromucosal spray,
solution
Page: 1 / 8

It is recommended that the drug be used by only one patient.

Before first use, the plastic cap should be taken off from the spray
pump.

After that, the spray applicator should be placed on the spray pump by
light pressure.

The applicator can move sideways and ensures correct application of
the spray in the oral
mucosa.

The applicator should be turned upwards, at a right angle from the
bottle.

Before first application of the spray, the spray pump should be first
pressed several times
until the spraying becomes uniform.

Wide open the mouth, direct the applicator toward affected area and
press the spray pump
as many times a