DELTAZINE 1:200,000 articaine HCl 4% with adrenaline 1:200,000, solution for injection 2.2 mL cartridge

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

articaine hydrochloride, Quantity: 88 mg; adrenaline (epinephrine) acid tartrate, Quantity: 0.02 mg (Equivalent: adrenaline (epinephrine), Qty 0.011 mg)

Available from:

Specialites Septodont Pty Ltd

INN (International Name):

adrenaline (epinephrine) acid tartrate,Articaine hydrochloride

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; sodium metabisulfite; sodium hydroxide; water for injections

Administration route:

Dental

Units in package:

50 cartridges

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

DELTAZINE 1:200,000 is indicated for local anaesthesia for simple dental procedures in adults, adolescents and children 4 years of age and older. DELTAZINE 1:200,000 is indicated only for dental procedures

Product summary:

Visual Identification: Clear aqueous solution in a Type 1 glass cartridge fitted with a rubber closure ("seal") and a rubber plunger; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-10-07

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – DELTAZINE 1:100,000 AND
DELTAZINE 1:200,000 (ARTICAINE HYDROCHLORIDE, ADRENALINE
(EPINEPHRINE) ACID TARTRATE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Articaine hydrochloride with adrenaline (epinephrine) acid tartrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DELTAZINE 1:100,000: articaine hydrochloride 4% with adrenaline
(epinephrine) acid tartrate
1:100,000 [i.e. articaine hydrochloride 40 mg/mL with adrenaline
(epinephrine) 10µg/mL]
DELTAZINE 1:200,000: articaine hydrochloride 4% with adrenaline
(epinephrine) acid tartrate
1:200,000 [i.e. articaine hydrochloride 40 mg/mL with adrenaline
(epinephrine) 5µg/mL]
DELTAZINE 1:100,000
Per 1.7 mL
cartridge
Per 2.2 mL
cartridge
ACTIVE INGREDIENTS
Articaine hydrochloride (INN)
68.0 mg
88.0 mg
Adrenaline (epinephrine) (as acid tartrate)
17.0 µg
22.0 µg
OTHER INGREDIENTS
Sodium chloride
2.72 mg
3.52 mg
Sodium metabisulfite
0.85 mg
1.1 mg
Sodium hydroxide solution (to adjust pH)
Water for injection q.s ad
1.7 mL
2.2 mL
Contains no antimicrobial agent.
DELTAZINE 1:200,000
Per 1.7 mL
cartridge
Per 2.2 mL
cartridge
ACTIVE INGREDIENTS
Articaine hydrochloride (INN)
68.0 mg
88.0 mg
Adrenaline (epinephrine) (as acid tartrate)
8.5 µg
11.0 µg
OTHER INGREDIENTS
Sodium chloride
2.72 mg
3.52 mg
Sodium metabisulfite
0.85 mg
1.1 mg
Sodium hydroxide solution (to adjust pH)
Water for injection q.s ad
1.7 mL
2.2 mL
Contains no antimicrobial agent.
Articaine hydrochloride is a local anaesthetic.
Adrenaline (epinephrine) acid tartrate is a vasoconstrictor.
2
3
PHARMACEUTICAL FORM
DELTAZINE 1:100 000 is a Clear, not opalescent, colourless solution
for injection cartridge,
practically free from visible particles. It is available in a 1.7mL or
2.2mL cartridge.
DELTAZINE 1:200 000 is a Clear, not opalescent, colourless solution
for injection cartridge,
practically free from visible particles. It is available in a 1.7mL or
2.2mL cartridge.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
DELTAZINE 1:100,000 is indicated for local or regional an