LIGNOSPAN SPECIAL 1/80000 2.2mL injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lidocaine hydrochloride monohydrate, Quantity: 20 mg/mL; adrenaline (epinephrine), Quantity: 12.5 microgram/mL (Equivalent: adrenaline (epinephrine) acid tartrate, Qty 22.8 microgram/mL)

Available from:

Specialites Septodont Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; potassium metabisulfite; disodium edetate; sodium hydroxide; water for injections

Administration route:

Infiltration

Units in package:

50x2.2mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 17 JULY 2003: Lignocaine solutions are indicated for the production of local anaesthesia in routine dental procedures and oral surgery by means of infiltration and nerve block techniques. Lignocaine solutions with adrenaline are recommended for oral surgery requiring prolonged duration of anaesthesia and haemostasis.

Product summary:

Visual Identification: Clear colourless liquid; Container Type: Cartridge; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1994-07-13

Patient Information leaflet

VARIATION TO THE REGISTRATION OF LIGNOSPAN SPECIAL
Specialites Septodont
June 2003
File: Septo/Lidocaine/Lignospan submission / lignospan CMI June03-V04
- 1 -
LIGNOSPAN SPECIAL
WHAT’S IN YOUR MEDICINE
ACTIVE INGREDIENTS
Cartridge
2.2 mL
1.8 mL
Lignocaine hydrochloride
44 mg
36 mg
Adrenaline (as acid tartrate)
27.5 µg
22.5 µg
OTHER INGREDIENTS:
Sodium chloride, sodium hydroxide, disodium edetate,
potassium metabisulfite, water for injections.
PRESENTATION:
Box of 50 cartridges single use, containing each 2.2 mL
or 1.8 mL of solution.
WHAT YOUR MEDICINE IS USED FOR AND HOW IT
WORKS
LIGNOSPAN SPECIAL is given by injection to cause
loss of feeling before and during dental procedures. It
contains two active ingredients: Lignocaine
hydrochloride, a local anaesthetic to prevent the pain,
and adrenaline tartrate, a vasoconstrictor, which makes
it, last longer (Adrenaline narrows the blood vessels at
the site of injection, which keeps the anaesthetic where
it’s needed for a longer time) and controls bleeding
during the surgery.
ADVICE BEFORE USING THE MEDICINAL PRODUCT
In deciding to use a medicine, the risks of using the
medicine must be weighed against the good it will do.
This is a decision you and your dentist will make. For
local anaesthetics, the following should be considered.
THIS PRODUCT SHOULD NOT BE USED IF:
- You are allergic to
•
adrenaline
•
lignocaine, procaine or any local
anaesthetic
•
sodium metabisulfite or any sulfites
•
any other ingredient included in the
product.
Symptoms of an allergic reaction may include
shortness of breath, wheezing or difficulty
breathing: swelling of the face, lips, tongue or
other parts of the body; rash, itching or hives
on the skin.
- You have arterial hypertension (high blood pressure),
coronary disease or valvular cardiac disease (heart or
circulation problems).
- You have an over active thyroid gland, whether or not
treated for this.
- You have cerebral arteriosclerosis (hardening in the
brain arteries).
- You have an inflammation (pain, swelling, redness a

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – LIGNOSPAN SPECIAL
(LIDOCAINE (LIGNOCAINE) HYDROCHLORIDE MONOHYDRATE,
ADRENALINE (EPINEPHRINE) ACID TARTRATE) SOLUTION FOR
INJECTION
1
NAME OF THE MEDICINE
Lidocaine (lignocaine) hydrochloride monohydrate with adrenaline
(epinephrine) (as acid
tartrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CARTRIDGE 2.2 ML
1.8 ML
Lidocaine (lignocaine) hydrochloride monohydrate .........44 mg
36 mg
Adrenaline (epinephrine)
............................................................27.5 µg
22.5 µg
(as acid tartrate)
Sodium chloride
............................................................................
14.3 mg
11.7 mg
Potassium metabisulfite
............................................................ 2.64 mg
2.16 mg
Disodium edetate
..........................................................................
0.55 mg
0.45 mg
Sodium hydroxide solution
(to adjust pH)
(to adjust pH)
Water for injection q.s. ad
........................................................... 2.2 mL
1.8 mL
For single patient use only. Contains no anti-microbial agent. Discard
unused contents after use.
LIGNOSPAN
SPECIAL
contains
a
local
anaesthetic
of
amide
type,
lidocaine
(lignocaine)
hydrochloride monohydrate (2%), combined with a vasoconstrictor,
adrenaline (epinephrine) as
acid tartrate (1/80,000).
3
PHARMACEUTICAL FORM
LIGNOSPAN SPECIAL is an injection, solution – a clear colourless
liquid.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Lidocaine (lignocaine) solutions are indicated for the production of
local anaesthesia in routine
dental procedures and oral surgery by means of infiltration and nerve
block techniques.
Lidocaine
(lignocaine)
solutions
with
adrenaline
(epinephrine)
are
recommended
for
oral
surgery requiring prolonged duration of anaesthesia and haemostasis.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The lowest dosage that results in effective anaesthesia for the
planned treatment should be used.
2
The dosage will depend upon the area of the oral cavity to be
anaesthetised, the vasculari