Septanest with Adrenaline 1/100,000 40mg/ml +10mcg/ml solution for injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ARTICAINE HYDROCHLORIDE, ADRENALINE

Available from:

Septodont 58 Rue du Pont de Créteil, 94100 SAINT MAUR DES FOSSES, France

ATC code:

N01BB58

INN (International Name):

ARTICAINE HYDROCHLORIDE 40 mg/ml ADRENALINE 10 µg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

ARTICAINE HYDROCHLORIDE 40 mg/ml ADRENALINE 10 µg/ml

Prescription type:

POM

Therapeutic area:

ANESTHETICS

Authorization status:

Authorised

Authorization date:

2005-06-30

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEPTANEST WITH ADRENALINE 1/200,000 40 MG/ML + 5 MICROGRAMS/ML,
SOLUTION FOR INJECTION
SEPTANEST WITH ADRENALINE 1/100,000 40 MG/ML + 10 MICROGRAMS/ML,
SOLUTION FOR INJECTION
articaine hydrochloride/adrenaline
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your dentist, doctor or
pharmacist.
−
If you get any side effects, talk to your dentist, doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Septanest with adrenaline is and what it is used for
2.
What you need to know before you are given Septanest with adrenaline
3.
How to use Septanest with adrenaline
4.
Possible side effects
5.
How to store Septanest with adrenaline
6.
Contents of the pack and other information
1.
WHAT SEPTANEST WITH ADRENALINE IS AND WHAT IT IS USED FOR
Septanest with adrenaline is used to numb (anaesthetise) your oral
cavity during dental procedures.
This medicine contains two active substances:
•
articaine, a local anaesthetic which prevents pain, and
•
adrenaline, a vasoconstrictor which narrows the blood vessels at the
site of injection, and thereby
prolongs the effect of articaine. It also decreases bleeding during
surgery.
You will be given Septanest with adrenaline by a dentist.
Septanest with adrenaline is for children over 4 years of age (ca. 20
kg in body weight), adolescents and
adults.
Depending on the kind of dental procedure performed, the dentist will
choose between the two
medicines:
•
Septanest with adrenaline 1/200,000 is usually used for simple and
short dental procedures
•
Septanest with adrenaline 1/100,000 is more adapted to procedures
lasting longer or with possible
significant bleeding.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SEPTANEST WITH ADRENALINE
DO NOT USE SEPTANEST WITH ADRENALIN

Summary of Product characteristics

PAGE 1 OF 16
SUMMARY OF PRODUCT CHARACTERISTICS
PAGE 2 OF 16
1
NAME OF THE MEDICINAL PRODUCT
Septanest with adrenaline 1/200,000 40 mg/ml + 5 micrograms/ml,
solution for injection
Septanest with adrenaline 1/100,000 40 mg/ml + 10 micrograms/ml,
solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Septanest with adrenaline 1/200,000 40 mg/ml + 5 micrograms/ml,
solution for injection
1 ml of solution for injection contains 40 mg of articaine
hydrochloride and 5 micrograms of
adrenaline (as adrenaline tartrate).
Each cartridge of 1.7 ml of solution for injection contains 68 mg of
articaine hydrochloride and 8.5
micrograms of adrenaline (as adrenaline tartrate).
Septanest with adrenaline 1/100,000 40 mg/ml + 10 micrograms/ml,
solution for injection
1 ml of solution for injection contains 40 mg of articaine
hydrochloride and 10 micrograms of
adrenaline (as adrenaline tartrate).
Each cartridge of 1.7 ml of solution for injection contains 68 mg of
articaine hydrochloride and 17
micrograms of adrenaline (as adrenaline tartrate).
Excipients with known effect: sodium metabisulfite (E223), sodium
chloride, sodium hydroxide.
Septanest with adrenaline contains 0.76 mg sodium per 1 ml of solution
i.e. 1.29 mg/1.7 ml.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Local and loco-regional anaesthesia in dental procedures.
Septanest with adrenaline is indicated in adults, adolescents and
children above 4 years of age (or from
20 kg (44 lbs) of body weight).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For professional use by physicians or dentists only.
Posology
For all populations, the lowest dose leading to effective anaesthesia
should be used. The necessary
dosage must be determined on an individual basis.
For a routine procedure, the normal dose for adult patients is of 1
cartridge, but the contents of less of
a cartridge may be sufficient for effective anaesthesia. At the
discretion of the