ATO MEPIVACAINE 3% mepivacaine hydrochloride 66mg/2.2mL injection cartridge

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mepivacaine hydrochloride, Quantity: 30 mg/mL

Available from:

Specialites Septodont Pty Ltd

INN (International Name):

Mepivacaine hydrochloride

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Infiltration

Units in package:

50x66mg/2.2mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT MAY 2003: ATO Mepivacaine 3% is indicated for the production of local anaesthesia in routine dental procedures and oral surgery by means of infiltration and nerve block techniques.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Cartridge; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2008-09-19

Patient Information leaflet

ATO MEPIVACAINE 3%
CONSUMER MEDICINE INFORMATION
WHAT’S IN YOUR MEDICINE
ATO Mepivacaine contains a local anaesthetic, Mepivacaine
hydrochloride.
ATO MEPIVACAINE
3%
ACTIVE INGREDIENTS
Cartridge 2.2 mL
Mepivacaine hydrochloride
66 mg
OTHER INGREDIENTS:
Sodium chloride, Sodium hydroxide solution, water for injections.
PRESENTATION:
Box of 50 cartridges for single use, containing each 2.2 mL.
WHAT YOUR MEDICINE IS USED FOR AND HOW IT WORKS
ATO MEPIVACAINE
3% contains one active ingredient, Mepivacaine hydrochloride, a local
anaesthetic to prevent
the pain and is given by injection to cause loss of feeling before and
during dental procedures.
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 before treatment.
THIS PRODUCT SHOULD NOT BE USED IF ANY OF THE FOLLOWING APPLY TO YOU:
-
You are allergic to mepivacaine, or any local anaesthetic and any
other ingredient included in the product
-
-
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 you are treated
for this.
-
You have cerebral arteriosclerosis (hardening in the brain arteries).
-
You have inflammation (pain, swelling, redness and heat) or infection
in the region of the proposed injection
-
Children under the age of 3 years old.
YOU MUST TELL YOUR DENTIST IF YOU HAVE THE FOLLOWING CONDITIONS:
-
You have problems with your heart, blood vessels, circulation and
heart rhythm.
−
You are taking any medicine
−
You have epilepsy.
−
You have hepatic (liver) or renal (kidney) diseases.
−
You have malignant hyperthermia (history or experience of a rapid rise
in body temperature to a dangerously
high level brought on by general anaesthesia.
−
You have prostatic hypertrophy (enlarged prostate).
−
You are pregnant or breast-feeding. If ATO MEPIVACAINE is used while
you are breas

Summary of Product characteristics

1
AUSTRALIAN
PRODUCT
INFORMATION
-
ATO
MEPIVACAINE
3%
(MEPIVACAINE HYDROCHLORIDE) INJECTION
1
NAME OF THE MEDICINE
Mepivacaine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ATO MEPIVACAINE 3%
CARTRIDGE 2.2 ML
ACTIVE INGREDIENTS
Mepivacaine hydrochloride
66 mg
OTHER INGREDIENTS
Sodium chloride
13.2 mg
Sodium hydroxide solution
(for pH adjustment)
Water for injections q.s.
2.2 mL
Contains no anti-microbial agent.
Mepivacaine hydrochloride is a local anaesthetic.
Contains mepivacaine hydrochloride 3% (30 mg/mL)
3
PHARMACEUTICAL FORM
ATO MEPIVACAINE 3% is a sterile aqueous injection, solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ATO MEPIVACAINE 3% is indicated for the production of local
anaesthesia in routine dental
procedures and oral surgery by means of infiltration and nerve block
techniques.
4.2
D
OSE AND METHOD OF ADMINISTRATION
One or more cartridges should be used on a single patient on one
occasion only during each
session of treatment. If only a portion of a cartridge is used, the
remainder must be discarded.
The lowest dosage that results in effective anaesthesia for the
planned treatment should be used.
The dosage will depend upon the area of the oral cavity to be
anaesthetised, the vascularity of the
oral tissues and the technique of anaesthesia.
2
Toxic doses vary widely between patients and toxic effects may occur
after any local anaesthetic
procedure.
Careful
observation
of
the
patient
must
be
maintained
after
administration
of
the
local
anaesthetic.
The product is injected either locally or in the vicinity of a dental
nervous trunk.
The safe dose for people with acute or chronic disease may be
substantially less than that for
healthy individuals.
_Adults _
A single cartridge (2.2 mL) is generally sufficient. Do not exceed
three cartridges (6.6 mL).
_Adolescents between 14 and 17 years _
The usual dosage is one cartridge (2.2 mL). Do not exceed 2 cartridges
(4.4 mL) in general cases.
_Children between 6 and 14 years _
The usual dose is 1.35 mL. Do not exceed 2.7 mL in usual