Lignospan Special

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

Adrenaline; Lignocaine hydrochloride

Sẵn có từ:

Specialites Septodont Pty Ltd

Lớp học:

Medicine Registered

Tờ rơi thông tin

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 ar

Đặc tính sản phẩm

VARIATION TO THE REGISTRATION OF A DRUG PRODUCT  
Specialites Septodont 
July 2003 

Septo / Lidocaine/ lignospan submission / Lignospan PI-July03-V05 
.H
2
O 
DESCRIPTION 
LIGNOSPAN SPECIAL contains a local anaesthetic of amide
type, lignocaine 
hydrochloride (2%), combined with a vasoconstrictor, adrenaline
tartrate (1/80.000). 

LIGNOCAINE HYDROCHLORIDE 
CAS [6108-05-0] Mr: 288.8 
Local and regional anaesthetic 
C
14
 H
23
 ClN
2
 O.H
2
O 

2-diethylaminoaceto-2’6’-xylidide hydrochloride monohydrate 
White crystalline powder practically odourless. Lignocaine
hydrochloride 
is very soluble in water, freely soluble in ethanol, and practically
insoluble in ether. 

ADRENALINE ACID TARTRATE 
CAS [51-42-3] Mr: 333.3 
C
13
 H
19
 NO
9

(R)-1-(3,4-di-hydroxyphenyl)-2-methylaminoethanol hydrogen tartrate 
White to greyish-white or light
brownish-grey, odourless, crystalline powder. Adrenaline 
acid tartrate 1.8 mg is approximately equivalent to 1 mg of
adrenaline. 

Cartridge  
2.2 mL 
1.8 mL 
Lignocaine hydrochloride .............................................44 mg 
36 mg 
Adrenaline .....................................................................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. 

PHARMACOLOGY 
PHARMACODYNAMICS 
Lignocaine stabilises the neuronal membrane by
decreasing its permeability to sodium ions 
and reversibly blocks the initiation and conduction of nerve i