XYLOCAINE PUMP SPRAY 10 %

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LIDOCAINE

Available from:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC code:

D04AB01

Pharmaceutical form:

SOLUTION

Composition:

LIDOCAINE 10 MG / 0.1 ML

Administration route:

TOPICAL

Prescription type:

Required

Manufactured by:

ASPEN PHARMA TRADING LTD, IRELAND

Therapeutic group:

LIDOCAINE

Therapeutic area:

LIDOCAINE

Therapeutic indications:

Surface anaesthesia in dental practice otorhinolaryngology, obstetric and anaesthesiology.

Authorization date:

2014-10-31

Patient Information leaflet

העדוה
לע
הרמחה
עדימ(
ןולעב )תוחיטב
אפורל
ןכדועמ(
05/2013
) :ךיראת
10
,רבמצד
2015
םש
רישכתה
תילגנאב
רפסמו :םושירה
XYLOCAINE SPRAY 10% NO. 116-41-25500
םש
לעב :םושירה
םראפ-וא-קט
הרביל
מ"עב
!דבלב תורמחהה טורפל דעוימ הז ספוט
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
INDICATION
CONTRAINDICATIONS
POSOLOGY, DOSAGE &
ADMINISTRATION
SPECIAL WARNINGS AND
SPECIAL PRECAUTIONS FOR
USE
Xylocaine spray contains
ethanol, due to its
flammable potential do not
expose to fire.
INTERACTIONS WITH OTHER
MEDICAMENTS AND OTHER
FORMS OF INTERACTIONS
PREGNANCY, FERTILITY AND
LACTATION
ADVERSE EVENTS
OVERDOSE
4.9
OVERDOSE
–
TREATMENT
OF
ACUTE
TOXICITY
If cardiovascular depression
is evident (hypotension,
bradycardia), ephedrine 5-10
mg i.v. should be given and
repeated if necessary, after
2-3 minutes.
6.4
NATURE
AND
CONTENT OF CONTAINER
The package includes a
spray nozzle
approximately 120mm
6.6
NATURE
AND
CONTENT OF CONTAINER
The
package
includes
a
single-use
spray
nozzle
approximately 120mm long.
הרביל -םראפ-וא-קט
מ"עב
זכרמ
קב
רה ,עדמל
םילשורי ,םיבצוח
.ד.ת
45054
םילשורי
9777508
:ןופלט
02-5870875
:סקפ
02-5870873
Email:
[e-mail] www.toplibra.co.il
long.
6.5
INSTRUCTIONS
FOR
USE AND HANDLING
…The nozzle must not be
shortened, otherwise the
spray
function
will
be
destroyed.
If cleaning of the nozzle is
desired the entire nozzle
can
be
submersed
in
boiling
water
for
5
minutes. The nozzle can be
autoclaved (20 minutes at
120°C).
Additional
short
spray
nozzles
are
available
separately.
6.7
INSTRUCTIONS
FOR
USE AND HANDLING
…The nozzle must not be
shortened, as it will affect
the spray function.
Nozzles
should
not
be
reused,
and
should
be
discarded after use.
ב"צמ
ובש ,ןולעה
תונמוסמ
תורמחהה
תושקובמה
לע
עקר
בוהצ
םייוניש
םניאש
רדגב
תורמחה

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
XYLOCAINE PUMP SPRAY 10%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine 10mg/metered dose.
Excipients with known effect: Each depression also delivers 1mg of
propylene
glycol (an excipient of the banana essence). Also contains ethanol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Non-sterile solution for topical application supplied in a pump spray,
with nozzles
for single use in an individual patient.
_ _
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Surface anaesthesia in dental practice otorhinolaryngology, obstetric
and
anaesthesiology.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
As with any local anaesthetic, the safety and effectiveness of
lidocaine depends on
the proper dosage, the correct technique, adequate precautions and
readiness for
emergencies.
The following dosage recommendations should be regarded as a guide.
The
clinician's experience and knowledge of the patient's physical status
are of
importance in calculating the required dose.
The degree of absorption from mucous membranes is variable but
especially high
from the bronchial tree. Application only to areas below the vocal
cords may
result in excessive plasma concentrations because of less transfer to
the intestine
and less first-pass loss.
Each actuation of the metered-dose valve delivers 10mg Lidocaine base.
It is
unnecessary to dry the site prior to application.
Xylocaine Pump Spray 10% should not be used on cuffs of endotracheal
tubes
(ETT) made of plastic.
(See also section 4.4)
-
Otorhinolaryngology: 3 metered doses for puncture of the maxillary
sinus or
other minor surgical procedures.
-
Obstetrics – During delivery: Up to 20 metered doses (200mg
lidocaine base).
-
Introduction of instruments, tubes and catheters into the respiratory
and
digestive tract: Up to 20 metered doses (200mg lidocaine base) for
procedures
in pharynx, larynx and trachea. During prolonged procedures up to 400
mg of
lidocaine may be administered. In additi