Lysobact Spray with Peppermint flavour spray

País: Armènia

Idioma: anglès

Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

ingredients actius:

lysozyme (lysozyme hydrochloride), cetylpyridinium chloride

Disponible des:

Bosnalijek d.d.

Codi ATC:

R02AA20

Designació comuna internacional (DCI):

lysozyme (lysozyme hydrochloride), cetylpyridinium chloride

Dosis:

20mg/ml+ 1,5mg/ml

formulario farmacéutico:

spray

Unidades en paquete:

30ml glass bottle with spraying pump and spray applicator

tipo de receta:

OTC

Estat d'Autorització:

Registered

Data d'autorització:

2023-07-08

Fitxa tècnica

1. NAME OF THE MEDICINAL PRODUCT
Lysobact Spray
®
with Peppermint Flavour (20 + 1.5) mg/ml oromucosal spray, solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of Lysobact Spray
®
with Peppermint Flavour solution contains:
Lysozyme hydrochloride 20.00 mg
(corresponding to 800 000 FIP U) [International Pharmaceutical
Federation units]
Cetylpyridinium chloride 1.50 mg
For excipients see part 6.1.
3. PHARMACEUTICAL FORM
Oromucosal spray, solution.
Colourless to light yellow solution smelling of peppermint.
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
(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
-
The plastic cap from the spray pump should be removed before first
application.
-
Turn the spray aplicator tube upwards, under the right angle in
relation to the initial
position (Figure 1).
1.3.1 Summary of Product Characteristics
SmPCD004874/1
LYSOBACT Spray with Peppermint flavour (20 + 1.5) mg/ml oromucosal
spray, solution
Page: 1 / 7
Figure 1.
-
After that, the spray applicator should be placed by mild pressure on
the spray pump.
-
Before first application of the spray, the spray pump should first be
pressed several times
until spraying becomes uniform.
-
The mouth should be wide opened, direct the applicator toward the
throat and press the spray
pump as many times as specified in the drug dosage (Figure 2).
Figure 2.
-
During spraying, the breath should be held. Do not swallow.
-
After
drug
application
the
applicator
should
be
turned
downwards
which
blocks
the
spraying.
-
Each bottle should only be used by one patient (not more) in order to
prevent the spread of
infection.
_Posology_
For a sing