XYLOCAINE

Nchi: Indonesia

Lugha: Kiindonesia

Chanzo: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Shusha Tabia za bidhaa (SPC)
09-09-2021

Viambatanisho vya kazi:

LIDOCAINE

Inapatikana kutoka:

MITSUBISHI TANABE PHARMA INDONESIA - Indonesia

INN (Jina la Kimataifa):

LIDOCAINE

Kipimo:

10 MG

Dawa fomu:

SPRAY TOPIKAL

Vitengo katika mfuko:

DUS, 1 BOTOL @ 50 ML (500 DOSIS)

Viwandani na:

ASPEN BAD OLDESLOE GMBH - Federal Republic of Germany

Idhini ya tarehe:

2021-09-09

Tabia za bidhaa

                                XYLOCAINE
LIDOCAINE
SPRAY 10MG/DOSE
PUMP SPRAY FOR TOPICAL ANAESTHESIA OF MUCOUS MEMBRANE
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active constituent:
1 dose XYLOCAINE pump spray contains lidocaine base 10 mg.
For excipients see _List of excipients._
PHARMACEUTICAL FORM
XYLOCAINE is presented as cutaneous spray, solution.
XYLOCAINE pump spray is a clear to almost clear, slightly
coloured liquid with menthol and banana flavour. The active
ingredient is dissolved in a mixture of water, ethanol and
polyethylene glycol 400.
THERAPEUTIC INDICATIONS
For the prevention of pain associated with the following
procedures:
•
Nasal procedures, e.g. puncture of the maxillary sinus
•
Oral and dental procedures, e.g. prior to injection
•
Procedures in the oropharynx, e.g. gastrointestinal endoscopy
•
Procedures in the respiratory tract, e.g. insertion of
instruments and tubes
•
Procedures in the larynx, trachea and bronchi
•
Procedures in obstetrics and gynaecology, e.g. vaginal
delivery, suturing of ruptures in the mucosa and cervical
biopsies
POSOLOGY AND METHOD OF ADMINISTRATION
XYLOCAINE pump spray is intended for use on mucous
membranes and provides efficient surface anaesthesia, which
lasts for approximately 10-15 minutes. The anaesthesia usually
occurs within 1-3 minutes, depending on the area of application.
As with any local anaesthetic, reaction and complications
are best averted by employing the minimal effective dosage.
Debilitated or elderly patients and children should be given doses
commensurate with their age and physical conditions.
Each activation of the metered dose valve delivers 10 mg
lidocaine base. It is unnecessary to dry the site prior to
application. No more than 20 spray applications should be used
in any adult to produce the desired anaesthetic effect.
The number of spray depends on the extent of the area to be
anaesthetised.
Dental practice
: 1-5 applications to the mucous
membranes
Otorhinolaryngology
: 3 applications for puncture of the
maxillary sinus
Obstetrics
: up to 20 applications
                                
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