LIDOCADREN TEVA

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

EPINEPHRINE AS BITARTRATE; LIDOCAINE HYDROCHLORIDE

Tersedia dari:

ABIC MARKETING LTD, ISRAEL

Kode ATC:

N01BB52

Bentuk farmasi:

SOLUTION FOR INJECTION

Komposisi:

LIDOCAINE HYDROCHLORIDE 36 MG / 1.8 ML; EPINEPHRINE AS BITARTRATE 22.5 MCG / 1.8 ML

Rute administrasi :

DENTAL INFILTRATION INJ.

Jenis Resep:

Required

Diproduksi oleh:

LABORATORIES INIBSA, S.A., SPAIN

Kelompok Terapi:

ANESTHETICS, LOCAL

Area terapi:

LIDOCAINE, COMBINATIONS

Indikasi Terapi:

Production of local anasthesia by nerve-block Infiltration technique.

Tanggal Otorisasi:

2015-07-31

Selebaran informasi

לע העדוה לע העדוה לע העדוה
( הרמחה
( הרמחה
( הרמחה עדימ עדימ עדימ
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
אפור
אפור
אפור
ןכדועמ(
ןכדועמ(
ןכדועמ(
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)
)
)
_______ ךיראת
JULY 27, 2015
__
תילגנאב רישכת םש
םושירה רפסמו
LIDOCADREN TEVA
 SOLUTION FOR INJECTION 144 03 31072 00
םושירה לעב םש
ABIC MARKETING LTD., POBOX 8077 NETANYA
_
ה טורפל דעוימ הז ספוט
דבלב תורמחה
!
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
INDICATION
CONTRAINDICATIONS
POSOLOGY, DOSAGE & ADMINISTRATION
_MAXIMUM DOSE _
Adults:
The maximum dose over a period of
24 hours is 500 mg of lidocaine (for a
person
of
70
kg),
which
must
not
exceed
7
mg/kg
of
body
weight
in
adults.
Children:
The dose will be adjusted according to
the patient’s age and weight, as well as
the type of surgery to be performed,
not
exceeding
5
mg/kg
of
body
weight.
The use of LIDOCADREN TEVA is
contraindicated
in
children
under
4
years of age.
_MAXIMUM DOSE _
Adults:
The maximum dose over a period of 24 hours is 490 500
mg of lidocaine (for a person of 70 kg), which must not
exceed 7 mg/kg of body weight in adults.
Children:
The dose will be adjusted according to the patient’s age
and
weight,
as
well
as
the
type
of
surgery
to
be
performed, not exceeding 5 mg/kg of body weight.
The use of LIDOCADREN TEVA is contraindicated in
children under 4 years of age.
LIDOCADREN TEVA is indicated for use in adults
and in children older than 4 years of age. The amount to
be injected should be determined by the age and weight
of
the
child
and
the
scale
of
the
operation.
The
anaesthetic technique must be carefully selected. Painful
anaesthetic techniques should be avoided. The behaviour
of
children
must
be
monitored
carefully
during
treatment. The mean dose for use is in the range 20 mg
to
30
mg
lidocaine
hydrochloride
per
session.
Alternativel

Karakteristik produk

LIDOCADREN TEVA Updated Working Copy 27. 7. 2015, RH
1.
NAME OF THE MEDICINAL PRODUCT
_ _
L
IDOCADREN TEVA

Solution for injection
Lidocaine hydrochloride + Epinephrine (Adrenaline)
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
1 ml of solution for injection contains:
Lidocaine hydrochloride
20.0 mg
Epinephrine (adrenaline)
0.0125 mg
(Equivalent to 0.02275 Epinephrine tartrate)
Excipients:
Sodium chloride
5.80 mg
Sodium metabisulphite
0.55 mg
1 cartridge (1.8 ml) contains 36 mg of lidocaine hydrochloride (2%)
and 0.0225 mg of epinephrine
([equivalent to 0.04095 mg of epinephrine tartrate] [1:80,000]).
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection, clear and colourless.
4.
CLINICAL PARTICULARS
_ _
4.1
THERAPEUTIC INDICATIONS
_ _
Production of local anaesthesia
by nerve-block infiltration technique
.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
LIDOCADREN TEVA is intended for use in adults, adolescents and
children above 4 years of age.
_ _
_POSOLOGY_
The
dosage
should
be
adjusted
individually
according
to
the
area
to
be
anaesthetised,
vascularisation of the tissues and anaesthetic technique to be used.
The recommended doses according to the technique used are described in
the table below.
Anaesthetic
technique
Recommended
dose
Adults
(70 kg)
Children
20 kg-child
40 kg-child
Infiltrations or
terminal
anaesthesia
in ml of solution
1 ml
0.3 ml
0.6 ml
in mg of
lidocaine HCl
20 mg
6 mg
12 mg
Truncal
anaesthesia
in ml of solution
1.5 – 2 ml
0.4 – 0.6 ml
0.8 – 1 ml
in mg of
lidocaine HCl
30 – 40 mg
8 – 12 mg
16 – 20 mg
LIDOCADREN TEVA RH SY 03.2016
2
_ _
_MAXIMUM DOSE _
Adults:
The maximum dose over a period of 24 hours is 490 mg of lidocaine (for
a person of 70 kg), which
must not exceed 7 mg/kg of body weight in adults.
Children:
The dose will be adjusted according to the patient’s age and weight,
as well as the type of surgery to
be performed, not exceeding 5 mg/kg of body weight.
The use of LIDOCADREN TEVA is contraindicated in children under 4
yea